DILIsym®

Quantitative systems toxicology (QST) software
for modeling drug-induced liver injury (DILI)

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Webinar

DILIsym® Applications in Drug Development – Perspectives from 2 Pharma Industry Executives & an Experienced Consultant

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U.S. FDA Renews Licenses of DILIsym Software

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DILIsym®

DILIsym Plays Critical Role in Submission to State of California for Common Analgesic Carcinogenicity Risk Assessment.

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Search results: DILIsym

DILIsym®

...the submodels within DILIsym: PBPK modeling Mitochondrial toxicity modeling Bile acid modeling Reactive nitrogen/oxygen species Innate immunity modeling Hepatocyte life cycle Clinical readouts SimPops™ DILIsym Development DILIsym development is supported... Read More


DILIsym Inputs from Cyprotex

DILIsym Services and Cyprotex, an Evotec Company, have teamed up to enhance the quality of your toxicology predictions! Cyprotex provides high quality in vitro data and expertise to support DILIsym... Read More


DILIsym Inputs from SOLVO

...times, DILIsym results also help with selection of future transporter assays to be completed, making the data collection / simulation cycle iterative. Team up with DILIsym and SOLVO today and... Read More


DILIsym Discovery Support Program (DDSP)

...in-house use of DILIsym. Our interdisciplinary team of experts can manage the experimental design and collection of in vitro data needed as DILIsym inputs, translate the in vitro data to... Read More


DILIsym Scientific Advisory Board

...provide strategic guidance and direction for our research and scientific programs, engaging individually with the DILIsym development team to address specific scientific areas, participate in DILIsym Review Sessions, and gather... Read More


DILIsym® 3-Day Training Workshop

...in a documented DILI event. A combination of presentations and interactive examples using DILIsym will illustrate how to gather the appropriate in vitro toxicity data, derive DILIsym related toxicity parameters,... Read More


FAQs

...a consortium of life science companies led by DILIsym Services, Inc., that is charged with developing the DILIsym software. DILIsym Software 1. What inputs do I need to run DILIsym... Read More


The DILIsym® 3-Day Training Workshop

...examples using DILIsym will illustrate how to gather the appropriate in vitro toxicity data, derive DILIsym related toxicity parameters, conduct simulations of expected outcomes and analyze results for impacting decisions.... Read More


Webinar: DILIsym® Applications in Drug Development – Perspectives from 2 Pharma Industry Executives & an Experienced Consultant

What do NURTEC™ ODT, TURALIO®, lixivaptan, solithromycin, JYNARQUE®, VEKLURI®, and UBRELVY® have in common? DILIsym®. The drug companies used the software platform for predicting and evaluating liver safety during their... Read More


The DILIsym 2-Day Introductory Virtual Workshop

...prior experience with DILIsym is not required. The course will use DILIsym X (DSX), the newest and most advanced release of DILIsym, but many of the guiding principles will be... Read More


Liver Safety Modeling and Analysis

...mechanistic safety modeling for your development pipeline. Use of the DILIsym SimPops® (interpatient and interspecies variability) Use of DILIsym for IVIVE DILIsym for Interpretation of Clinical Biomarkers DILIsym Predicts Low... Read More


2021 SLP Model-Informed Drug Development Conference

...Clinical ALT Elevations Using DILIsym Quantitative Systems Toxicology Modeling Yang K Keywords: ALT, DILIsym, FIH/Phase I, QST modeling, SLP MIDD+ Virtual Conference, SLP2021MIDDSoftware: DILIsym®Conference: SLP MIDD+Division: DILIsym Services Read More... Read More


DILIsym® 2-Day Training Workshop

DILIsym® 2-Day Training Workshop Research Triangle Park, North Carolina Sep 12-13 This two-day, hands-on course provides a working knowledge of the basic theories and application of state-of-the-art quantitative system toxicology... Read More


DILIsym Plays Critical Role in Submission to State of California for Common Analgesic Carcinogenicity Risk

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DILIsym Services Inc. Releases DILIsym® Version 8A

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U.S. FDA Renews Licenses of DILIsym Software

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U.S. FDA Renews Annual DILIsym Software Licenses for 2022

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DILIsym Services Virtual Workshops

Join our Quantitative Systems Toxicology (QST) & Quantitative Systems Pharmacology (QSP) modeling experts for a 1 or 2-day course using DILIsym® X and NAFLDsym® software!... Read More


DILIsym Services Inc., a Simulations Plus Company, Releases DILIsym® Version 6A

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FDA Review of Approved Drug, Ubrogepant, Included DILIsym Simulations

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First Approved Cancer Treatment for TGCT Included DILIsym Simulations in FDA Review

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DILIsym Introduction Seminar

DILIsym Introduction Seminar June 3rd Mielparque Kyoto, Japan Register Here!... Read More


DILIsym Introduction Seminar

DILIsym Introduction Seminar June 7 Shinagawa Intercity, Japan Register Here!... Read More


DILIsym Services Inc., a Simulations Plus Company, Releases DILIsym® Version 7A

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DILIsym Services Presents Important DILIsym and NAFLDsym Software Applications at the Virtual AASLD Liver Meeting

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Optimization of Exposure, Safety, and Efficacy through Modeling and Simulation: a Simulations Plus workshop on machine learning + PBPK (GastroPlus®), PKPD modeling (KIWI™), QSP (NAFLDsym®), and QST (DILIsym®)

Optimization of Exposure, Safety, and Efficacy through Modeling and Simulation: a Simulations Plus workshop on machine learning + PBPK (GastroPlus®), PKPD modeling (KIWI™), QSP (NAFLDsym®), and QST (DILIsym®) Workshop ACoP... Read More


Webinar: Using DILIsym to Predict Hepatoxicity Risk During Pre-clinical Development

Using DILIsym to Predict Hepatoxicity Risk During Pre-clinical Development Presented by SOLVO Biotechnology & GlaxoSmithKline July 25 7:00 AM – 8:30 AM PDT Register Here!    ... Read More


DILIsym® v8A Release Webinar

DILIsym® v8A Release: New Features for Predicting & Understand Drug-induced Liver Injury Thursday, January 24, 2019 8:00 AM PST Register Here!... Read More


DILIsym® 2-Day Training Workshop

DILIsym® 2-Day Training Workshop Sep 11-12 Research Triangle Park, North Carolina Register Here!... Read More


U.S. FDA Renews Annual DILIsym Software Licenses

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Workshop: Using DILIsym to Assess the Liver Safety of Drugs and Drug Candidates 

We’ll be hosting a free workshop Using DILIsym to Assess the Liver Safety of Drugs and Drug Candidates at the 9th annual American Conference on Pharmacometrics in San Diego, California.... Read More


Simulations Plus to Acquire DILIsym Services, Inc.

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Applications and Regulatory Impact

...renewed their DILIsym licenses package. A commentary published by employees of the FDA on the DILIsym software praised early examples of DILIsym use and commented on the prospect of future... Read More


US FDA Procures DILIsym Software License Package

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Webinar: QST and the Transformation in Drug Safety Assessment

...for the last decade has been developing a Quantitative Systems Toxicology (QST) model (DILIsym®) to improve mechanistic understanding and therefore prediction of liver safety liabilities of new drug candidates. The... Read More


U.S. FDA Renews DILIsym Software Licenses

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Simulations Plus Closes Acquisition of DILIsym Services, Inc.

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Mechanistic Modeling of Drug-Induced Liver Injury Due to mtDNA Depletion in DILIsym®

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Application of the DILIsym® QST drug-induced liver injury model to evaluate the carcinogenic hazard potential of acetaminophen

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DILIsym: Quantitative systems toxicology impacting drug development

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DILIsym Simulations Support the Liver Safety of Ubrogepant in New Toxicological Sciences Publication

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An Introduction to DILIsym® Software, a Mechanistic Mathematical Representation of Drug-Induced Liver Injury

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DILIsym Services, an SLP Company, Launches Consortium for Drug-Related Kidney Injury

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SOT Annual Meeting & ToxExpo

...(Hall B) James J. Beaudoin Scientist II, DILIsym Services Division, Simulations Plus Simulating Multidrug Resistance Protein 3 (MDR3) Inhibition-Mediated Cholestatic Liver Injury Using DILIsym X, a Quantitative Systems Toxicology (QST)... Read More


Final_DILIsym Review Session 23_Protein Binding in DILIsym

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DILIsym Services Inc. Initiates Development of IPFsym™

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Mechanistic Modeling Of Mitochondrial Biogenesis Within Dilisym Could Explain Clinically Observed Adaptation Of Serum Alanine Aminotransferase Elevations

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Simulations Plus Subsidiary DILIsym Awarded Grant for up to $1.7 Million For Model Development

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Mechanistic Modeling With Dilisym® Predicts Dose-Dependent Clinical Hepatotoxicity Of Amg 009 That Involves Bile Acid Transporter Inhibition

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PBPK

...inputs from ADMET Predictor®) in tandem with DILIsym. However, some cases may require the built-in PBPK framework within DILIsym (e.g. acetaminophen toxicity). The basic DILIsym PBPK submodel framework consists of... Read More


Mechanistic Modeling with Dilisym® Predicts Species Differences in CKA Via Multiple Hepatotoxicity Mechanisms

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DILIsym® v8A Release Webinar

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FINAL_DILIsym_Review_Session_24_Lipotoxicity_in_DILIsym_July_2018

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Modeling of Furosemide in DILIsym™ Model Reveals Testable Hypotheses about Hepatotoxicity Mechanisms

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DILIsym 8A New Features for Predicting & Understand Drug-Induced Liver Injury

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Clinical Readouts

What Clinical Readouts are Included in DILIsym? The primary clinical readouts of DILI include numerous biomarkers, many of which are included in DILIsym. DILIsym includes classic serum biomarkers such as... Read More


How To Improve Your Compound Design & Screening Using ADMET Property Prediction and PK Simulations Day 2

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Quantitative Systems Toxicology Modeling Using DILIsym Suggests That Mitochondrial Biogenesis Could Explain Adaptation to Drug-Induced Liver Injury (DILI)

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Utilizing DILIsym, a QST Platform, to Extract More from Your Data to Support Decisions

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A message from Brett Howell, President of DILIsym Services

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Modeling DILI Drug-Drug Interactions with DILIsym

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DILIsym® Applications in Drug Development – Perspectives from 2 Pharma Industry Executives & an Experienced Consultant

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Academic Licenses

DILIsym Services Inc. offers special academic pricing and various options for academic licensing to accredited academic institutions. There are two different types of academic licenses, both described below. Academic Research... Read More


Custom QSP Software

You probably know of the many QSP/QST platforms available for licensing and consulting from the DILIsym Services division of Simulations Plus, but did you know that all of those great... Read More


DILIsym Awarded $1.5 Million Phase II NIH Grant

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DILIsym® 3-Day Workshop

This three-day, hands-on course provides a working knowledge of the basic theories and application of state-of-the-art quantitative system toxicology (QST) modeling and simulation software (DILIsym®) for the analysis of the potential for drugs and drug candidates to cause drug-induced liver injury (DILI), or for the investigation of mechanisms involved in a documented DILI event. A combination of presentations and interactive examples using DILIsym will illustrate how to gather the appropriate in vitro toxicity data, derive DILIsym related toxicity parameters, conduct simulations of expected outcomes and analyze results for impacting decisions.

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DILIsym: Modeling Drug-Induced Liver Injury & Beyond

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DILIsym Releases NAFLDsym® Version 2A

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DILIsym® Flyer

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DILIsym version 7A Release Webinar

https://attendee.gotowebinar.com/register/5047597686858109185... Read More


DILIsym Services Partners with Large Pharmaceutical Company to Begin QSP Model Development for Heart Failure

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Assessing Effects of BHV-0223 40 mg Zydis® Sublingual Formulation and Riluzole 50 mg Oral Tablet on Liver Function Test Parameters Utilizing DILIsym®

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Simulating Multidrug Resistance Protein 3 (MDR3) Inhibition-Mediated Cholestatic Liver Injury Using DILIsym X, a Quantitative Systems Toxicology (QST) Modeling Platform

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Using DILIsym, A Quantitative Systems Toxicology (QST) Software Tool of Drug-Induced Liver Injury (DILI), To Assess DILI Risk in Drug Development

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NAFLDsym®

...on license terms and pricing. Alternatively, click here to find out more about how you can take advantage of NAFLDsym through a consulting arrangement with the DILIsym Services experts. DILIsym... Read More


The DILIsym® 3-Day Training Workshop

This three-day, hands-on course provides a working knowledge of the basic theories and application of state-of-the-art quantitative system toxicology (QST) modeling and simulation software (DILIsym®) for the analysis of the potential for drugs and drug candidates to cause drug-induced liver injury (DILI), or for the investigation of mechanisms involved in a documented DILI event. A combination of presentations and interactive examples using DILIsym will illustrate how to gather the appropriate in vitro toxicity data, derive DILIsym related toxicity parameters, conduct simulations of expected outcomes and analyze results for impacting decisions.

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Using DILIsym to Assess the Liver Safety of Drugs and Drug Candidates

FREE! This 1 day hands‐on workshop provides a working knowledge of the basic theories and application of state‐of‐the‐art quantitative system toxicology (QST) modeling and simulation software (DILIsym) for the analysis of the potential for drugs and drug candidates to cause drug‐induced liver injury (DILI), or for the investigation of mechanisms involved in a documented DILI event. A combination of presentations and interactive examples using DILIsym will illustrate how to gather the appropriate in vitro toxicity data, derive DILIsym related toxicity parameters, conduct simulations of expected outcomes and analyze results for impacting decisions. This is a beginner’s course ‐prior experience with DILIsym is not required.
Register Online Here!

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Elucidating Differences in the Hepatotoxic Potential of Tolcapone and Entacapone With DILIsym(®), a Mechanistic Model of Drug-Induced Liver Injury.

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Quantitative Systems Toxicology Modeling Using DILIsym Suggests That Drug-Induced Liver Injury Can Be Enhanced by Co-administered Drugs and Mitigated by Mitochondrial Biogenesis

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An Update to the DILI-sim Initiative and the DILIsym Tool

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What’s New in DILIsym® v7A?

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Linking physiology to toxicity using DILIsym®, a mechanistic mathematical model of drug-induced liver injury

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Quantitative Systems Toxicology Modeling Using DILIsym Suggests That Drug-Induced Liver Injury (DILI) Can Be Enhanced by Co-administered Drugs and Mitigated by Mitochondrial Biogenesis

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Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and CBDusing Quantitative Systems Toxicology (QST) DILIsym Correctly Predicts CBD ALT Elevations and Evaluates Interaction Mechanism(s)

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In Silico studies of novel Sildenafil self-emulsifying drug delivery system absorption improvement for pulmonary arterial hypertension

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RENAsym

  Want to avoid more development failures due to safety and reduce risks for patients? Join TODAY!   The RENAsym Consortium is a pre-competitive partnership between the DILIsym Services division... Read More


DILIsym™, a Mechanistic Model of Drug-Induced Liver Injury, Supports the Interpretation of Elevated Liver Transaminase Levels in a Healthy Volunteer Pooled Safety Population for an Orphan Drug Designed for a Life-Threatening Situation

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Prediction of the Liver Toxicity of the Endothelin Receptor Antagonists Sitaxsentan and Ambrisentan for the Treatment of Pulmonary Arterial Hypertension with a Quantitative Systems Toxicology Tool (DILIsym)

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Assessment of the Mechanism for Remdesivir-Associated Clinical ALT Elevations Using DILIsym Quantitative Systems Toxicology Modeling

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Application of the DILIsym® Quantitative Systems Toxicology drug-induced liver injury model to evaluate the carcinogenic hazard potential of acetaminophen

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Assessment of the Mechanism for Remdesivir-Associated Clinical ALT Elevations Using DILIsym Quantitative Systems Toxicology Modeling

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Quantitative systems toxicology (DILIsym) modeling of the acetaminophen (paracetamol) mode of action (MOA) pathway for hepatotoxicity supports that acetaminophen is not a carcinogenic hazard in humans

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AAPS 2020 PharmSci 360

...Toxicology (DILIsym) Modeling of the Acetaminophen (Paracetamol) Mode of Action (MOA) Pathway for Hepatotoxicity Supports that Acetaminophen Is Not a Carcinogenic Hazard in Humans Quantitative Systems Toxicology Modeling Using DILIsym... Read More


ACoP 10

...on the prediction of the potential for drugs and candidates to cause drug-induced liver injury (DILI) with DILIsym®. DILIsym examples will illustrate typical data inputs utilized and address how to... Read More


Assessing Effects of BHV-0223 40 mg Zydis® Sublingual Formulation and Riluzole 50 mg Oral Tablet on Liver Function Test Parameters Utilizing DILIsym®

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In vitro to in vivo extrapolation and species response comparisons for drug-induced liver injury (DILI) using DILIsym™: a mechanistic, mathematical model of DILI.

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QSP/QST Services from the DILIsym Services division of Simulations Plus

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MITOsym®

...more marked effects at higher concentrations). This parameter option is mirrored in DILIsym v7A. MITOsym v3B was released in January of 2018 with minor updates. DILIsym Services Home MITOsym® is... Read More


SimPops®

...SimPops allow DILIsym users to explore the inter-individual variability in response to potential DILI-causing drugs. SimPops introduce variability into several important model parameters, including: baseline glutathione levels, cellular response to... Read More


Liver Safety Comparison of Two Treatments for Autosomal-Dominant Polycystic Kidney Disease (ADPKD) Using Quantitative Systems Toxicology Software (DILIsym)

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Quantitative Systems Toxicology (DILIsym) Modeling of the Acetaminophen Cellular Pathways for Liver Toxicity Supports that Acetaminophen is Not a Carcinogenic Hazard in Humans

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Development of a Quantitative Systems Toxicology Model of Drug-Induced Cholangiocyte Injury in DILIsym

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Use of a systems model of drug-induced liver injury (DILIsym(®)) to elucidate the mechanistic differences between acetaminophen and its less-toxic isomer, AMAP, in mice.

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DILIsym® 2-Day Training Workshop

This is a beginner’s course for clinicians, pharmaceutical/biotechnology scientists, and engineers in the areas of toxicology, clinical pharmacology, pharmacovigilance, DMPK and ADME - prior experience with DILIsym is not required. The course will use DILIsym, but the guiding principles will be taught in a software-independent manner.

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DILIsym_User_Training_Add_data_plot_slides

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DILIsym_v7A_Whats_New

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DILIsym_User_Training_Param_sweep_slides

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DILIsym_v5A_User_Training

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DILIsym_v3A_User_Training

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DILIsym_v6A_User_Training

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FINAL_DILIsym_v7A_Feature_Update_Training

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DILIsym_v2A_User_Training

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DILIsym_v2B_User_Training

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DILIsym_v3B_User_Training

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DILIsym_ROS_Data_Collection

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DILIsym_v4A_User_Training

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DILIsym_v1A_User_Training

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Saturable_ETC_Setup_DILIsym

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DILIsym_User_Training_Output_panel_slides

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FINAL_AASLD-FDA Liver Meeting_2021_DILIsym_DILI DDI Biogenesis

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Watkins DILIsym Review Clin Liver Dis 2020

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FINAL_AASLD-FDA Liver Meeting_2021_DILIsym_DILI DDI Biogenesis_narration

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DILIsym v8A Flyer

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FINAL_DILIsym_Review_Session_25_SimPops_August_2018

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FINAL_DILIsym_Review_IVIVE_Nov_2018

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RENAsym™

Want to avoid more development failures due to safety and reduce risks for patients? Join TODAY! The RENAsym Consortium is a pre-competitive partnership between the DILIsym Services division of Simulations... Read More


FINAL_DILIsym_v8A_Release_Webinar_Slides

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FINAL_DILIsym_SOT_2019_LunchNLearn

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Longo BHV-0223 DILIsym AANEM2018_092518a_PRINT_FINAL

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RTP Sept 2018 – DILIsym – PC

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DILIsym_Training_Videos_Defining_Mitochondrial_toxicity_parameters

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Longo BHV-0223 DILIsym FDA DILI Meeting May 2019_FINAL

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FINAL_DILIsym_MEEX_Solvo_Boston_Sept_2019

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DILIsym-Flyer-9-27-18

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FINAL_DILIsym_IDDST_Aug_17_2018

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DILIsym-Workshop-Sept2021

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RTP Sept 2018 – DILIsym

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DILIsym_Training_ROS_in_vitro_parameterID_Oct_2015

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DRAFT_DILIsym_PBSS_Dec_2018_v2

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DILIsym_Training_Videos_Parameters_from_data_transporter

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FINAL_mtDNA_depletion_DILIsym_ACoP_2016

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FINAL_BAL30072_DILIsym_ACoP_2016

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DILIsym_Training_Mitochondrial_toxicity_data_gathering

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FINAL_Bile_acids_DILIsym_SOT_2013

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FINAL_CCl4_DILIsym_SOT_2014

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FINAL_CKA_DILIsym_ACoP_2016

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FINAL_DAMPs_DILIsym_ISSX_2013

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DILIsym- Modeling Drug-Induced Liver Injury & Beyond

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FINAL_Furosemide_DILIsym_SOT_2012

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FINAL_GGF2_DILIsym_ASCPT_2017

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Final_Hyperbilirubinemia_DILIsym_ASCPT_2016

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FINAL_Lixivaptan_DILIsym_ACoP_2017

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FINAL_Macrolides_DILIsym_ASCPT_2017

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FINAL_TAK875_DILIsym_SOT_2017

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FINAL_ALT_interpretation_DILIsym_ASCPT_2013

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Final_Troglitazone_DILIsym_ISSX_2014

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FINAL_APAP_Carc_DILIsym_PharmSci_2020_Howell

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KidneyWeek_2020_DILIsym_PO0234

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Yang_et_al_Liver_Meeting_2020_Remdesivir_DILIsym_Poster

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Longo_et_al_TAK875_DILIsym_ToxSci

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2021-06-17 16.03 DILIsym Services at SMB2021_NH

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2021-06-17 16.03 DILIsym Services at SMB2021_LC

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2018-01-30 07.58 What’s New in DILIsym version 7A_

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DILIsym-DataSheet_10-10-17

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San Diego 2018 – DILIsym

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SLP2021MIDD_KYang_DILIsym_Efavirenz

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DILIsym Applications in Drug Development_ Perspectives from Pharma Industry & Experienced Consultant

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FINAL_DILIsym_Impact_Webinar_April_2021

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Final_AMG009_DILIsym_ACoP_2015

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DILIsym Simulations Support the Liver Safety of Ubrogepant in New Toxicological Sciences Publication

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Exhib_Session_SimsPlus_DILIsym_SOT_2018

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Physiologically-based Pharmacokinetic (PBPK) Modeling in DILIsym

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DILIsym_Training_Videos_Data_Gathering_Bile_Acids

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DILIsym_Training_Input_Panel_Sept_2015

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DILIsym_Training_Videos_Bilirubin_model (2)

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DILIsym_User_Training_in_vitro_data_collection_mitochondria_oxidative_stress

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DILIsym User Training_In vitro data collection_BA transporter inhibition and IC

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Introduction to Quantitative Systems Toxicology (QST) and the DILIsym Software

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Importance of Integration of DILI Mechanisms within DILIsym

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Using the Specified Data Feature within DILIsym

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Using the DILIsym Optimization Feature

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SimPops_DILIsym_Part1_Background_Q2_2018

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FINAL_SOT_2018_poster_DILIsym_Biogenesis

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Clinical Monitoring in DILIsym

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Introduction to the DILIsym Software Environment

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Using GastroPlus PBPK to Drive DILIsym Simulations

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SimPops_DILIsym_Part2_StepByStep_Q2_2018

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Representation of the Innate Immune System in DILIsym Software

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SOT_2018_Sit_Ambri_DILIsym_FINAL

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Representing Reactive Metabolites in DILIsym

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TAK875_DILIsym_Cyprotex_Solvo_Takeda_SOT_v7

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FINAL_DILIsym_SOT_2020_LunchNLearn

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Watkins_Shoda_DILIsym_Webinar_April_2020

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FINAL_ASCPT_2020_poster_DILIsym_APAP_MOA_Kyunghee Yang

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DILIsym Simulations with Exploratory Mitochondrial Biogenesis Parameters

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Mitochondrial DNA Depletion within DILIsym

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Reactive Nitrogen/Oxygen Species

...balance of ROS/RNS within DILIsym is determined by the relative contributions of production and clearance. It has been demonstrated that compounds can either directly or via reactive metabolites elicit increases... Read More


Hepatocyte Life Cycle

What is the Hepatocyte Life Cycle Submodel? This submodel captures the life cycle of the hepatocytes. Explicit tracking of individual hepatocyte pools (necrotic, apoptotic, and mitotic) is done with DILIsym,... Read More


Optimization of Exposure, Safety, and Efficacy through Modeling and Simulation: a Simulations Plus workshop on machine learning + PBPK (GastroPlus), PKPD modeling (KIWI), QSP (NAFLDsym), and QST (DILIsym)

Modeling and simulation (M&S) is now a critical activity within the drug development process. The Simulations Plus family of companies has a wide range of experience and tools available to enable effective M&S. This workshop will provide a background knowledge of multiple M&S approaches and describe how Simulations Plus has partnered with developers to help facilitate better decisions and smarter investments. This workshop will provide an excellent foundation for those looking to learn more about various types of M&S approaches, as well as those looking for implementable solutions. This workshop is FREE for all attendees.

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Webinar: DILIsym Simulations Support the Liver Safety of Ubrogepant in New Toxicological Sciences Publication

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DILIsym Services Licensing Form

DILIsym Services Licensing Form Prospect Name* Prospect Name* First Last Company* Company* Prospect Email* Prospect Email* DILIsym® Quantity* How many DILIsym® licenses would you like? MITOsym® Quantity* How many MITOsym®... Read More


DILIsym Overview

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DILIsym Simulations Support the Liver Safety of Ubrogepant in New Toxicological Sciences Publication

Register Here!... Read More


The DILI-sim Initiative Annual Meeting

The DILI-sim Initiative Annual Meeting Research Triangle Park, NC The DILI-sim Initiative is a consortium of life science companies led by DILIsym Services, Inc., a Simulations Plus company, and charged... Read More


2-Day QST Virtual Workshop

...experience with DILIsym is not required. The course will use DILIsym X, the newest and most advanced release of DILIsym, but many of the guiding principles will be taught in... Read More


Privacy Policy

...we collect and use personal data only as it might be needed to deliver to you our world-class software products, consulting services, and websites – cognigencorp.com, dilisym.com, lixoft.com, and simulations-plus.com... Read More


Real-world Considerations in Pharma for QSP Modeling

...panel discussion will follow. Speakers: Viera Lukacova, Chief Scientist, Simulations Plus, Inc. Kyunghee Yang, Senior Scientist, DILIsym Services Brett Howell, Divisional President, DILIsym Services Scott Siler, Chief Scientific Officer, DILIsym... Read More


ACoP 9

...Phillips, and David Jawarowicz will be exhibiting in booths #1 & 2. An ACoP9 pre-meeting workshop will be held on Saturday, October 6, entitled: Using DILIsym to Assess the Liver... Read More


Corporate Licenses

Corporate licenses to DILIsym® are available by joining the DILI-sim Initiative as one of the member benefits. Corporate licenses to MITOsym® and the SimPops® feature are included in licenses to... Read More


Bile Acids

...mixed in DILIsym by specifying the inhibition constant (i.e. Ki or IC50) and accompanying alpha value. If data are not available to determine the mode of inhibition, a sensitivity analysis... Read More


Sitemap

...DILIsym® Services DILIsym Services Licensing Form RENAsym Scientific Advisory Board DSSI Team DILI-sim Initiative DILIsym Development DILIsym Scientific Advisory Board RENAsym Distributor Form Download GastroPlus Complimentary Training Sign-Up Form GPUG... Read More


Mitochondrial Function

...oxidation. Moreover, alterations in the mitochondrial proton gradient due to the accumulation of bile acids can affect ATP synthesis and provide the ability for DILIsym to simulate how multiple mechanisms... Read More


Modeling and Simulation Scientist

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IPFsym™

...The DILIsym Services division of SLP applies the IPFsym modeling software in proprietary services projects by performing simulations of compounds to evaluate and model their efficacy and other effects on... Read More


ASCPT Network & Community Experience

Scott Q Siler, Ph.D. is the Chief Scientific Officer of the DILIsym Services division of Simulations Plus. Dr. Siler will speak during the Systems Pharmacology track on Thursday, January 13th... Read More


16th Annual Simulations Plus User Forum Reception

2017 Simulations Plus User Forum at the AAPS Annual Meeting San Diego, CA Tuesday Nov. 14 Topics to be discussed: DILIsym Services joins the Simulations Plus family – learn more... Read More


Webinar IPFsym™, a platform to support the development of effective treatments for IPF patients

...is making it challenging. Join DILIsym Services Chief Scientific Officer, Scott Q Siler, who will describe the features and use of IPFsym v1A to support the development of effective treatments... Read More


Partners and Collaborators

...Quantitative Systems Pharmacology (QSP) offerings to include potential damage to the kidney. More details can be found here: Simulations Plus Subsidiary DILIsym Awarded Grant for up to $1.7 Million For... Read More


Webinar: What’s New in DSX™

What’s New in DSX™? DILIsym is quantitative systems toxicology (QST) software that integrates in vitro mechanistic data and PBPK predictions of drug concentration in the liver to predict clinical liver... Read More


SOT Annual Meeting & ToxExpo

...of Drug-Induced Cholangiocyte Injury in DILIsym” Brett Howell has a podium presentation on March 13 (8:00- 8:15am) in Room 321 entitled: “Assessing Effects of BHV-0223 40 mg Zydis Sublingual Formulation... Read More


SOT ToxExpo

SOT 57th Annual Meeting and ToxExpo San Antonio, Texas March 11-15 Simulations Plus and DILIsym Services are sponsoring the SOT Biological Modeling Specialty Section awards and will be exhibiting in... Read More


ILDsym™

...development decision-making. The DILIsym Services division of SLP has conducted simulations of compounds in proprietary projects to evaluate and model their efficacy and assess effects on other key characteristics related... Read More


QSP Virtual Workshop

This is a beginner’s course for mechanistic modelers, pharmacologists, clinicians, pharmaceutical/biotechnology scientists, and engineers in the specific area of clinical and quantitative systems pharmacology (QSP) for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). Prior experience with NAFLDsym is not required. The course will focus on NAFLDsym v2A, but many of the guiding principles will be taught in a software-independent manner. Class size is limited to encourage interaction with the course instructors and among attendees. Virtual networking among industry, government, and academic scientists is part of the experience!

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QSP Modeling of NAFLD & NASH

...large pharmaceutical companies, supporting clinical trial design optimization and clinical development decision making. DILIsym Services, Inc. applies the NAFLDsym modeling software in proprietary services projects by performing simulations of compounds... Read More


CANCELED: SOT Lunch & Learn

...platforms DILIsym (liver injury) and RENAsym (kidney injury). Application examples will be shared. John DiBella to present “Mechanistic ML/PBK Modeling to Support Next Generation Risk Assessment” Scott Siler to present... Read More


CANCELED: SOT 59th Annual Meeting & ToxExpo

...QST safety platforms DILIsym (liver injury) and RENAsym (kidney injury). Application examples will be shared. John DiBella to present “Mechanistic ML/PBK Modeling to Support Next Generation Risk Assessment” Scott Siler... Read More


Innate Immunity

...molecules in APAP hepatotoxicity. These include liposomal clodronate (for macrophage depletion), a HMGB1 antagonist, a TNF-α antagonist, and exogenous HGF. Learn more about other submodels within DILIsym: PBPK modeling Mitochondrial... Read More


GastroPlus® “Workshop from Home” April 13 GastroPlus® Introduction with Maxime Le Merdy

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In vivo Dissolution and Precipitation

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GastroPlus® “Workshop from Home” April 14 Special population predictions with Viera Lukacova

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ADMET Predictor® 9.5 Webinar

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Postdoctoral Training Position in Modeling and Simulation of Drug-Induced Liver Injury or Fatty Liver Disease Therapies

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6 Things You Need to Know about Diane Longo

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Simulations Plus Reports Record Second Quarter FY2018 Revenue

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Clinical DILI and State-of-the-Art Solutions

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Postdoctoral Training Position – M&S of Drug-Induced Liver Injury and related QSP/QST areas

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Mechanistic Modeling Aids in the Interpretation of Alanine Aminotransferase Elevations Associated with Clinical Ischemic Liver Injury

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2021 Cardiac Physiome Workshop

...is FREE. 4:20-4:55 PM ET – Scott Q. Siler, CSO at DILIsym Services will participate in a panel discussion including topics on validation framework, collaboration opportunities and career opportunities for... Read More


CANCELED: ASCPT Annual Meeting

...James Clary, Inger Darling, and Ryan Franke Kyunghee Yang will be presenting a poster on March 18 entitled: “Quantitative Systems Toxicology (DILIsym) Modeling of the Acetaminophen (APAP) Mode of Action... Read More


2020 Systems Modelling in the Pharmaceutical Industry – Problem Solving Workshop

...12.00-15.00 instead of one-week in-person workshop. Any plans for future one-week workshop in the summer of 2021 will be announced later in the year. Sponsored by DILIsym Register Here!  ... Read More


Live Stream Learning with Simulations Plus

...sure to register for each session.   Tuesday’s Agenda: 30 min presentation + 15 min Q&A: Brett Howell: Modeling DILI Drug-Drug Interactions with DILIsym 10 min posters + 5 min... Read More


Toxicity Webinar

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The GastroPlus® Additional Dosage Routes Seminar Series IM with Viera Lukacova

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The GastroPlus® Additional Dosage Routes Seminar Series Ocular with Maxime Le Merdy

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BMSS Webinar: Quantitative Systems Toxicology as a Tool for Explaining and Predicting Drug-Related Organ Toxicity

...drug development pipeline. Speakers: Jeff Woodhead & Lisl Shoda from DILIsym, Jay Mettetal from Astra-Zeneca, Melissa Hallow from UGA, and Eric Sobie from Mt. Sinai School of Medicine Register Here... Read More


International Society of Pharmacometrics Virtual Quantitative Systems Pharmacology Week 2020

...Tuesday August 25, at 12:00-12:15 PM Kyunghee Yang will be presenting her poster, “Quantitative Systems Toxicology (DILIsym) Modeling of the Acetaminophen (APAP) Mode of Action Pathway for Liver Toxicity Supports... Read More


Quantitative Modeling Uncovers a Potential Limitation in the Putative Mechanism of CCl4 Hepatotoxicity

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American Thoracic Society 2022

...grown to tackle asthma, COPD, lung cancer, sepsis, acute respiratory distress, and sleep apnea, among other diseases. Visit with Scott Q. Siler, Chief Scientific Officer, DILIsym services at the event.... Read More


Webinar: QSP Modeling of Fibrosis in Liver, Lung, and Heart

  Let’s put 2020 behind us and begin 2021 with a webinar about healing— well, the physiologic processes of wound healing, anyway.   DILIsym Services expert modelers Diane Longo, Grant... Read More


About

...Simulations Plus DILIsym becomes a wholly owned subsidiary of Simulations Plus. DILIsym is the global leader in the simulation of drug-induced liver injury (“DILI”). Learn More 2016 October 10, 2016... Read More


MIDD+ Registration

...the drug development journey, expert modelers from Cognigen, DILIsym Services, Lixoft, and Simulations Plus will present novel modeling and simulation technologies to promote public health and safety through innovative scientific... Read More


QSP/QST Modeling Scientist

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Planning for the Next Pandemic workshop

...cohort of young and diverse group of researchers into responsible scientists who will be better prepared for the next pandemic. Join DILIsym services division Scientist II Celeste Vallejo at the... Read More


Clinical Development

...DILIsym® to provide insight into any liver injury issues you face. Want to outsource modeling & simulation activities to our experts? We’ve got experience with all types of analyses, including:... Read More


FDA/CDER and AASLD 2021 DILI Conference XVIII

...Valproate (VPA) and (CBD) using Quantitative Systems Toxicology (QST) Quantitative systems toxicology (QST) to investigate mechanisms contributing to clinical bilirubin elevations Quantitative Systems Toxicology Modeling Using DILIsym Suggests That Drug-Induced... Read More


American Thoracic Society (ATS) 2021

Scott Siler, Chief Scientific Officer of DILIsym Services, Inc., to present, “Using Quantitative Systems Pharmacology Modeling to Understand the Pathophysiology of Idiopathic Pulmonary Fibrosis” Rationale Patients with idiopathic pulmonary fibrosis... Read More


Preclinical Development

...the GastroPlus PBPK modeling platform to determine the maximum tolerated dose earlier. Finally, our DILIsym® platform, when combined with in vitro data, can help give you insight into possible liver... Read More


DSSI Team

...team members, please click on their photos below. Meet our DILIsym Services Team Brett Howell President Details Scott Q. Siler CSO Details Lisl Shoda Assoc. VP and Dir. of Immunology... Read More


2017 AAPS Annual Meeting and Exposition

...@ 10:25am. Divisional president of DILIsym Services Brett Howell will be hosting a talk on Quantitave Systems Toxicology Modeling of Drug-Induced Liver Injury in room #26 on Nov. 15. https://www.aaps.org/annual-meeting-and-conferences/annual-meeting... Read More


FDA DILI Conference

...Assessing Effects of BHV-0223 40 mg Zydis® Sublingual Formulation and Riluzole 50 mg Oral Tablet on Liver Function Test Parameters Utilizing DILIsym® Zack Kenz will attend and present poster on... Read More


SMB 2020 Annual Meeting

Society for Mathematical Biology 2020 Annual Meeting August 17-20, 2020 Presentation “DILIsym, Modeling Drug- Induced Liver Injury and Beyond” from Zack Kenz on Wednesday, August 19 from 2:30 – 3:00... Read More


Grill the GastroPlus® Gurus Webinar

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AAPS Annual Meeting: PharmSci 360

...(ADPKD) Using Quantitative Systems Toxicology Software (DILIsym) Tuesday, Nov 6 3:30 PM – 4:30 PM James Mullin‘s– poster W1230-05-037 will be presented by Viera Lukacova In Vitro to In Vivo... Read More


2022 SLP Model-Informed Drug Development

Improving Health Through Innovative Solutions in Model-Based Drug Discovery Get inspired by thought leaders, scientific experts and practitioners from Cognigen, DILIsym Services, Lixoft, and more at Simulations Plus’ second annual... Read More


Solvo BioTech Meet the Expert Transporter Conference

Solvo’s Meet the Experts Transporters Conference September 3-5 Cambridge, Massachusetts Dan O’Connor will be in attendance. Brett Howell will be hosting a talk entitled: Utilizing DILIsym, a QST Platform, to... Read More


PKPlus™ 2.5 Release Webinar

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BIT’s 16th Annual Congress of International Drug Discovery Science and Technology

...Friday, August 17 from 2:50-3:15 PM. His presentation is entitled Using DILIsym, A Quantitative Systems Toxicology Modeling Tool of Drug-induced Liver Injury (DILI), to Assess DILI Risk in Drug Development... Read More


November 2020 News/Events

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Comparison of the Hepatotoxic Potential of Two Treatments for Autosomal-Dominant Polycystic Kidney DiseaseUsing Quantitative Systems Toxicology Modeling

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Quantitative Systems Toxicology Approaches to Understand and Predict Drug-Induced Liver Injury

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Simulations Plus Forms Scientific Advisory Board for RENAsym Consortium

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Providing Insight into Novel Dosing Protocols Using a Quantitative Systems Pharmacology (QSP) Model of Drug-Induced Liver Injury

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Use of a Quantitative Systems Pharmacology (QSP) Model to Predict Liver Toxicity in Simulated Populations

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Simulations Plus and the University of Pittsburgh Drug Discovery Institute Receive SBIR Grant Funding for Large Molecule Safety Collaboration

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Simulations Plus Releases RENAsym® Version 1A Software for Kidney Injury

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Mechanistic Insights into Drug-Induced Liver Injury for Macrolide Antibiotics using Quantitative Systems Toxicology Modeling

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Exploring BSEP inhibition-mediated toxicity with a mechanistic model of drug-induced liver injury

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QST Applications, Use of Data and Species Differences

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What’s New in DSX™

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Quantitative Systems Toxicology Modeling Supports Safety Determination for Ubrogepant, a Novel CGRP Inhibitor

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Mechanistic Investigations Support Liver Safety of Ubrogepant

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Simulations Plus Announces Senior Management Changes

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Assessing Effects of Sublingual BHV-0223 and Oral Riluzole on Liver Function Test Parameters

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Simulations Plus Reports Third Quarter FY2017 Financial Results

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Analyzing the Mechanisms Behind Macrolide Antibiotic-Induced Liver Injury Using Quantitative Systems Toxicology Modeling

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Simulations Plus Reports FY2017 and Fourth Quarter FY2017 Financial Results

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Simulations Plus Reports Preliminary Revenues for Fourth Quarter and Fiscal Year 2017

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Assessing the Role of Intracellular Binding Protein in Drug-Induced Bile Acid Transporter Inhibition Using QuantiativeSystems Pharmacology (QSP) Modeling

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September 2020 News/Events

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Prediction of Safety Margin and Optimization of Dosing Protocol for a Novel Antibiotic using Quantitative Systems Pharmacology Modeling

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Simulations Plus Releases RENAsym® Version 1A Software for Kidney Injury

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April 2021 News/Events

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August 2020 News/Events

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Real-world Considerations in Pharma for QSP Modeling

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Game Changing: The Latest Developments in the Machine Learning/ PBPK/QST Modeling Space

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Quantitative systems toxicology (QST) reproduces species differences in PF‐04895162 liver safety due to combined mitochondrial and bile acid toxicity

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August 2021 News/Events

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In silico modeling to optimize interpretation of liver safety biomarkers in clinical trials

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Hepatotoxicity of Compound V Evaluated with Quantitative Systems Toxicology

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Quantitative systems toxicology (QST) to investigate mechanisms contributing to clinical bilirubin elevations

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Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and (CBD) using Quantitative Systems Toxicology (QST)

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Development of a Direct CD8+ T Cell Activation QSP Model for Ovalbumin in the Context of Liver Injury Advances Groundwork for Mathematical Representation of Idiosyncratic Drug-Induced Liver Injury (iDILI)

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December 2020 News/Events

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A Rapid Method to Estimate Hepatocyte Loss Due to Drug‐Induced Liver Injury

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Activation of CD8+ T Cells in the Context of Amodiaquine-Induced Liver Injury Advances Groundwork for Mathematical Representation of Idiosyncratic Drug-Induced Liver Injury (iDILI)

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Quantitative Systems Toxicology (QST) to Investigate Mechanisms Contributing to Clinical Bilirubin Elevations

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Quantitative Systems Toxicology Analysis of In Vitro Mechanistic Assays Reveals Importance of Bile Acid Accumulation and Mitochondrial Dysfunction in TAK-875-Induced Liver Injury

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C++ Programmer

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Application of a Mechanistic Model to Evaluate Putative Mechanisms of Tolvaptan Drug-Induced Liver Injury and Identify Patient Susceptibility Factors.

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QSP Modeling of Fibrosis in Liver, Lung, and Heart

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Modeling Insights on Species Differences in Response to CD8+ T cell-mediated Liver Injury

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Representation of Efavirenz mediated Drug Induced Liver Injury (DILI) Using Quantitative Systems Toxicology (QST)

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Quantitative Systems Toxicology (QST) Modeling of Drug-Induced Liver Injury and Adaptation

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July 2020 News/Events

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An analysis of N-acetylcysteine treatment for acetaminophen overdose using a systems model of drug-induced liver injury

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Mechanistic Modeling Reveals the Critical Knowledge Gaps in Bile Acid-Mediated DILI

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May 2021 News/Events

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The role of quantitative systems pharmacology modeling in the prediction and explanation of idiosyncratic drug-induced liver injury

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Simulations Plus Receives $1.7 Million Grant for BIOLOGXsym™ Macromolecule Safety Software

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June 2020 News/Events

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Simulations Plus to Support Development of Radiation Countermeasure via New QSP Platform (RADAsym) and Pharmacometrics Modeling

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Quantitative Systems Toxicology Modeling Predicts that Reduced Biliary Efflux Contributes to Tolvaptan Hepatotoxicity

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September 2021 News/Events

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Quantitative Systems Toxicology Analysis of In Vitro Mechanistic Assays Reveals Importance of Bile Acid Accumulation in TAK-875-induced Liver Injury

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January 2020 News/Events

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QSP Modeling of Fibrosis Across Diseases

Fibrosis is a critical aspect of many diseases that are yet untreated with adequate pharmaceutical intervention. This half day workshop covers the basic theories and applications of quantitative systems pharmacology (QSP) modeling focused on fibrosis, including special emphasis on the slow developing nature of the etiology and the upstream, downstream, and clinical outcome/biomarker indicators that must be considered. Fibrosis of the liver via NASH and fibrosis of the lung as with idiopathic pulmonary fibrosis (IPF) will be used as key examples. The NAFLDsym® and IPFsym® software tools will serve as example model platforms. Presentations, demonstrations, and interactive examples will illustrate typical data inputs utilized and address how to run simulations of expected outcomes and analyze results for impacting decisions. This course is useful for all individuals interested in these fields – prior QSP experience is not required, nor is a deep existing knowledge of fibrosis. Attendees will understand the following important aspects of modeling fibrosis: key components of the pathophysiology, including initiation and stimulation of collagen production via fibroblasts and/or stellate cells, interaction with the immune system, resolution of fibrosis, and biomarkers; examples of targets represented for in silico evaluation; and stratification of simulated populations to address a planned or possible clinical study. The process of representing fibrosis across different diseases and organs will also be discussed.

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Prediction of pH-Dependent Drug-Drug Interactions for Basic Drugs using PBBM Modeling: Industry Case Studies

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Mechanistic Modelling of Drug-Induced Liver Injury: Investigating the Role of Innate Immune Responses

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Use Of Systems Toxicology Modeling To Investigate Mechanisms Of Liver Enzyme Elevations Mediated By Solithromycin And Other Macrolides

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February 2021 News/Events

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Evaluating the Hepatotoxicity of Compound V with QST/QSP Modeling

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November 2021 News/Events

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Simulations Plus Reports Record Preliminary Revenues for Third Quarter FY2017

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October 2020 News/Events

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Computational Exploration of the Role of a Prototypical Damage-Associated Molecular Pattern (DAMP) Molecule in Acetaminophen Hepatotoxicity

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May 2021 GastroPlus Newsletter

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Webinar: Introducing ILDsym, a New Tool to Facilitate Development of Drugs to Treat Interstitial Lung Disease

  Wednesday, April 20, 2022 8:00- 9:00 AM PDT Speakers: Lisl Shoda and Zack Kenz Systemic sclerosis (SSc), also known as scleroderma, is a rare connective tissue and autoimmune disease... Read More


The DILI‐sim Initiative: Insights into Hepatotoxicity Mechanisms and Biomarker Interpretation

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Prospective Liver Safety Comparison of Two Treatments for Autosomal-Dominant Polycystic Kidney Disease (ADPKD) Using Quantitative Systems Toxicology Modeling

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February 2022 News/Events

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Office Manager/Administrative Coordinator

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Looking to the future of drug-induced liver injury: an interview with Paul B Watkins

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Modeling drug- and chemical-induced hepatotoxicity with systems biology approaches

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IPFsym™, a platform to support the development of effective treatments for IPF patients

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Office Manager/Administrative Coordinator

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RENAsym, a QST Model to Predict Drug-Induced Kidney Injury

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Using Quantitative Systems Toxicology to Investigate Observed Species Differences in CKA-Mediated Hepatotoxicity

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In Silico and in Vitro Simulations to Predict Idiosyncratic DILI: What is on the Horizon?

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Simulations Plus Releases IPFsym version 1A, State-of-the-Art Quantitative Systems Pharmacology (QSP) Software for Idiopathic Pulmonary Fibrosis (IPF)

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Mathematical Modeling in Industry: Building Models to Advance Drug Development

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Quantitative Systems Toxicology Modeling Provides Novel Mechanistic Insights into Disease-related Tolvaptan Hepatotoxicity​

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Representation of Efavirenz-mediated Drug-Induced Liver Injury (DILI) Using Quantitative Systems Toxicology (QST)

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February 2020 News/Events

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Marketing and Administrative Coordinator

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Assessing the Role of Intracellular Binding Protein in Drug-Induced Bile Acid Transporter Inhibition Using Quantitative Systems Pharmacology (QSP) Modeling

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March 2020 News/Events

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April 2020 News/Events

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May 2020 News/Events

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Capturing Interpatient Variability with SimPops

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Applying the QSP Model NAFLDsym® to Predict and Understand NASH Treatments

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Representation of Crizotinib and Pazopanib-mediated Drug-Induced Liver Injury (DILI) Using Quantitative Systems Toxicology (QST)

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January 2021 News/Events

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Live Stream Learning with Simulations Plus: Day One

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2-Day QST Virtual Workshop

This is a beginner’s course for clinicians, pharmaceutical/biotechnology scientists, and engineers in the areas of toxicology, clinical pharmacology, pharmacovigilance, DMPK and ADME - prior experience with DILIsym is not required. The course will use DILIsym X, the newest and most advanced release of DILIsym, but many of the guiding principles will be taught in a software-independent manner. Class size is limited to encourage interaction with the course instructors and among attendees. Virtual networking among industry, government, and academic scientists is part of the experience!

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Using Quantitative Systems Toxicology (QST): Improving the Safety of Drugs While Reducing Animal Testing

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December 2021 News/Events

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QSP/QST Capabilities Flyer

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Applying in silico-in vitro-in vivo extrapolation (IS-IVIVE) techniques to predict exposure and guide risk assessment

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A mechanistic model of drug-induced liver injury AIDS the interpretation of elevated liver transaminase levels in a phase I clinical trial

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NDA 211-765 (ubrogepant, AGN-241688)

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Yo-Yo Dieting Predicted to Contribute to Fibrosis Score Reductions in Untreated (Placebo) Cohorts

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Systems Pharmacology Modeling Predicts Hepatotoxic Potential Of Troglitazone And Pioglitazone

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July 2021 News/Events

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MITOsym®: A Mechanistic, Mathematical Model of Hepatocellular Respiration and Bioenergetics

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Refining Liver Safety Risk Assessment: Application of Mechanistic Modeling and Serum Biomarkers to Cimaglermin Alfa (GGF2) Clinical Trials

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Mechanistic Modeling Reveals the Most Important Unknowns in Bile Acid-Mediated DILI

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June 2021 News/Events

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Mathematically modeling CD8+ T cell-mediated drug induced liver injury (DILI): from ovalbumin to amodiaquine in mice

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Mechanistic Modeling Predicts Drug-Induced HyperbilirubinemiaThat Involves Inhibition Of Enzymes And Transporters

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March 2021 News/Events

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Simulations Plus Presented Breakthrough Scientific Data at Top Liver Disease Conference

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Quantitative Systems Pharmacology Modeling of Fibrotic Diseases

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Your #1 Ranked Team for Exposure and Safety Solutions!

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Advancing Calcitonin Gene-Related Peptide Receptor Antagonists Using Quantitative Systems Toxicology Modeling to Characterize Next-in-Class Compounds Compared to the Hepatotoxic First in Class Telcagepant

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Business Development Director, Quantitative Systems Pharmacology

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Advancing Calcitonin Gene-Related Peptide Receptor Antagonists Using Quantitative Systems Toxicology Modeling to Characterize Next-in-Class Compounds Compared to the Hepatotoxic First in Class Telcagepant

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Introducing ILDsym, a New Tool to Facilitate Development of Drugs to Treat Interstitial Lung Disease

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April 2022 News/Event

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January 2022 News/Events

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Home

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Assessing and Managing DILI Risk in Trials: A Consultant’s Perspective

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Simulations Plus Releases GastroPlus™ Version 9.6

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Mechanistic PBPK modeling of special population groups – considerations and opportunities

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Mechanistic Analysis of Cisplatin-Induced Acute Kidney Injury Using Quantitative Systems Toxicology Modeling

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Adapting a quantitative systems toxicology model of mitochondrial dysfunction in liver to kidney

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Can Bile Salt Export Pump Inhibition Testing in Drug Discovery and Development Reduce Liver Injury Risk? An International Transporter Consortium Perspective

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Quantitative Systems Toxicology (QST) Supports Differentiated Liver Safety for a Next-in-Class Compound

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Simulations Plus Reports First Quarter FY2018 Financial Results

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QSP Modeling of Liver AMPK Activation Using NAFLDsym Is Predicted to Reduce Steatosis in NAFLD Patients

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QSP/QST Modeling Support for NASH Drug Development

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Mechanistic Modeling And Hepatic Biomarker Data From Ggf2 (Cimaglermin Alfa)-Treated Subjects In Phase 1 Clincial Trials Suggest Low Likelihood Of Progressive Liver Injury

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Using Systems Pharmacology Modeling to Understand the Pathophysiology of NAFLD and Response to Dietary Intervention in a Simulated Population

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Systems pharmacology modeling of drug-induced hyperbilirubinemia: Differentiating hepatotoxicity and inhibition of enzymes/transporters

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Sandwich-Cultured Hepatocytes as a Tool to Study Drug Disposition and Drug-Induced Liver Injury

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Systems pharmacology modeling predicts delayed presentation and species differences in bile acid-mediated troglitazone hepatotoxicity.

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Using Quantitative Systems Toxicology (QST) to Assess Drug Safety: The Experience of the DILIsimInitiative. ®

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Synergy Between Two Mechanisms of Action Contributes to Species Differences in the Liver Safety Profile for PF-04895162

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Mechanisms Underlying Species Differences in Hepatotoxicity

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Synergy Between Two Mechanisms of Action Contributes to Species Differences in the Liver Safety Profile for PF-04895162

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Quantitative Prediction of Cisplatin-Induced Acute Kidney Injury Using RENAsym, a Mechanistic Quantitative Systems Toxicology Model, and Renal Proximal Tubule Epithelial Cell In vitro Assays

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Quantitative Systems Toxicology Modeling of Cisplatin Nephrotoxicity Using in vitro Assays of Proximal Tubule Epithelial Cells for Mechanistic Toxicity Pathways

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Simulations Plus Offers Rapid Response COVID-19 Research Initiative

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GastroPlus™ 9.6 Release Webinar: Improvements Supporting R&D Through Regulatory Interactions

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NOMINATING COMMITTEE CHARTER 2022

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Simulations Plus Reports Record First Quarter FY2021 Financial Results

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Introducing, IPFsym™ the QSP modeling software for idiopathic pulmonary fibrosis

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PBBM PBPK Modeling Scientist

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Quantitative Systems Pharmacology (QSP) Model Predicts Lack of Efficacy for Cenicriviroc, a CCR2/5 Antagonist, in NAFLD/NASH Patients

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Predicting the Efficacy of Obeticholic Acid Treatment for Non-Alcoholic Steatohepatitis (NASH) Using NAFLDsym, a Quantitative Systems Pharmacology Model of Non-Alcoholic Fatty Liver Disease

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2021 MIDD+ Welcome and Introduction

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Quantitative Systems Pharmacology Modeling Using NAFLDsym Recapitulated Clinically Observed Histological Responses and Serum Markers to NGM282 in NASH Patients

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CARDIOsym QSP model prediction of wound healing response following myocardial infarction

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Extending MAM/PBPK modeling approaches to predict non‐oral delivery of drugs 

FREE! The focus of this 1‐day workshop will be to discuss development of MAM/PBPK models for major non oral administration routes (nasal/pulmonary, dermal, ocular, and oral cavity) and how they can be applied to address key development questions. A combination of presentations and interactive examples using the GastroPlus™ PBPK modeling platform will illustrate how to parameterize baseline models and, once validated, how they can be deployed to predict FIH exposure and simulate the impact of formulation changes on local and systemic exposure to identify clinically relevant specifications.

Please note - this FREE workshop is open to anyone – registration to the ACoP conference is not required. You will need to register your attendance to the workshop below.
Register Online Here!

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Quantitative Systems Toxicology (QST) Modeling of Drug-Induced Acute Proximal Tubule Epithelial Cell Injury and Associated Renal Hemodynamic Responses

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Quantitative Systems Toxicology Identifies the Mechanism and Data Gaps for Evaluating the Hepatotoxicity of Compound V

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Finance – Accounts Receivable Specialist

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Mathematical Modeling with NAFLDsym® Supports the Role of Adiponectin in the Reduction of Steatosis by the Anti FGFR1/KLB Bispecific Antibody

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Financial Conflict of Interest Policy

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NAFLDsym® Flyer

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DILI-sim Initiative Q4 Update Meeting

DILI-sim Initiative Q4 Update Meeting Dec. 14 7:30 – 9:00 am PST (10:30 – 12:00 EST) A GoToMeeting event open to members of the DILI-sim Initiative and the DILI-sim Initiative... Read More


Introduction to Phase III track with Beth Ludwig

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SLP Investor Presentation Q2FY22

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Proof-of-concept Simulations Using BIOLOGXsym, a Novel Quantitative Systems Toxicology (QST) Modeling Platform for Predicting Biologics-induced Liver Injury (BILI), Recapitulate Clinically Observed Hepatotoxicity of GGF2

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Quantitative Systems Pharmacology Modeling of FGF19 Pathway Using NAFLDsym Prospectively Predicted Liver Fat and Serum Biomarker Responses to MET409 in NASH Patients

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Quantitative Systems Toxicology (QST) Modeling of Cimaglermin Alfa (GGF2) Hepatotoxicity Shows the Potential of BIOLOGXsym to Predict Biologics-Induced Liver Injury (BILI)

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Workshops

Virtual Workshops Jun 6, 2022 Online Complimentary Introduction to GastroPlus® This introductory, hands-on training session will provide instruction on the GastroPlus user interface (GUI) and cover essential software operation. Training... Read More


Mechanistic modeling of biologics-induced liver injury (BILI) predicts hepatotoxicity of Tocilizumab through both on- and off-target effects

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Modeling of Cyclosporine A-Induced Acute Kidney Injury with RENAsym®

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BIOLOGXsym

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Evaluating Nephrotoxicity of Cisplatin in Rats with RENAsym, a Mechanistic Model of Drug-Induced Acute Kidney Injury

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Modeling of Indinavir-Induced Crystal Nephropathy in RENAsym®

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March 2022 News/Events

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Suppressing TGF-β activation to reduce lung fibrosis: In search for an efficacious dose regimen for alpha V integrin inhibitors

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Mechanistic Modeling of Kidney-Injury Molecule 1 (KIM-1) as a biomarker for Cisplatin-Induced Acute Kidney Injury

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GastroPlus®

The GastroPlus PBBM / PBPK modeling and simulation package – supporting internal research through regulatory filings… As a researcher in the life sciences space, you can’t measure everything as a... Read More


Simulations Plus Annual Forum “Partner with the Good Guys” at PharmSci 360

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Evaluating the Nephrotoxicity of Exemplar Compounds Using a Mechanistic Model of Drug-Induced Acute Kidney Injury

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Mechanistic Modelling of the Linkage Between Proximal Tubule Cell Sublethal Injury and Tubular Sodium Reabsorption Impairment

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Development of Drugs to Treat NAFLD/NASH using Quantitative Systems Pharmacology Modeling

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Virtual Patient Generation Strategies for Non-Alcoholic Fatty Liver Disease

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Ceftolozane/tazobactam population pharmacokinetics and dose selection for further clinical evaluation in pediatric patients with complicated urinary tract or complicated intraabdominal infections

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Mechanistic Modeling of Cyclosporine A-induced Acute Kidney Injury with RENAsym®

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Simulations Plus Announces Leadership Changes at Cognigen

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Upcoming Workshops

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NMPA’s Center for Drug Evaluation Adds Licenses of GastroPlus®

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Simulations Plus Reports Third Quarter FY2019 Financial Results

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Simulations Plus Sets Date for 3rd Quarter 2019 Earnings Release and Conference Call

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What’s Next for Fit-for-Purpose (F4P) Models?

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Policy on Disclosure and Management of Financial Conflicts of Interest related to Public Health Service Research

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Improving Interpretation of New and Old Serum Biomarkers of Drug-Induced Liver Injury Through Mechanistic Modeling

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NAFLDsym v2A Release Webinar

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Development of Quantitative Systems Toxicology Model to Predict Drug Induced Acute Kidney Injury via mtDNA Depletion Pathway

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Zonal Hepatic Stellate Cell (HSC) Activation in Nonalcoholic Steatohepatitis (NASH) Characterized by A Mathematical Model

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Using Quantitative Systems Pharmacology Modeling to Understand the Effects of Acetyl CoA Carboxylase (ACC) Inhibition on Liver and Plasma Triglycerides in a Simulated Population

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IPFsym Flyer™

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Simulations Plus Reports FY2018 and Fourth Quarter FY2018 Financial Results

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Mathematical Modeling with NAFLDsym Supports the Role of Adiponectin in the Reduction of Steatosis by the Anti-FGFR1/KLB Bispecific Antibody

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Yo-Yo Dieting Predicted to Contribute to Fibrosis Score Reductions in Untreated (Placebo) Cohorts

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Simulations Plus Announces Employee Bonuses

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DILI-sim Initiative

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Simulations Plus Reports Third Quarter FY2018 Financial Results

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Zonal Extracellular Matrix (ECM) Accumulation in Nonalcoholic Steatohepatitis (NASH) Characterized by a Mathematical Model of Fibrosis

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Using Quantitative Systems Pharmacology Modeling to Understand the Pathophysiology of Idiopathic Pulmonary Fibrosis

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NAFLDsym Application Showcase: Key Examples of NAFLDsym Use within Drug Development

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