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Absorption Predictions: Current Capabilities and Knowing the Gaps
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Absorption Predictions: Current Capabilities and Knowing the Gaps
  • September 11, 2022
  • Presentation

Absorption Predictions: Current Capabilities and Knowing the Gaps

Authors: Lukacova V
Conference: ISSX
Keywords: Advanced Compartmental Absorption Transit (ACAT) model, dissolution, in vivo, mechanistic absorption models (MAM), oral absorption, solubility
Software: ADMET Predictor®, GastroPlus®
Division: PBPK

Number of different processes contribute to net drug absorption

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Complex Delivery Routes and Generics: The Next Frontier for PBBM/PBPK Modeling
  • July 20, 2022
  • Presentation, Videos

Complex Delivery Routes and Generics: The Next Frontier for PBBM/PBPK Modeling

Authors: Spires J
Conference: CRS
Keywords: bioequivalence, generic drugs, in vitro, in vivo, pbbm, PBPK modeling
Software: GastroPlus®
Division: PBPK

Generic drug development for locally acting drug products is a fast-growing field of interest

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Data required to build a fit-for-purpose PBPK model: How much is necessary?
  • June 23, 2022
  • Presentation

Data required to build a fit-for-purpose PBPK model: How much is necessary?

Authors: Ketkar AR
Conference: DISSO
Keywords: biopredictive dissolution, modeling and simulation, PBPK modeling, physiological based biopharmaceutics models (PBBM)
Software: ADMET Predictor®, DDDPlus™, GastroPlus®, MembranePlus™
Division: PBPK

PBPK/PBBM model development can be initiated at any stage of product development

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Predictive Dissolution Modeling with Clinically Relevant Specifications
  • June 15, 2022
  • Presentation

Predictive Dissolution Modeling with Clinically Relevant Specifications

Authors: Suarez-Sharp S
Conference: IFPAC
Keywords: biopharmaceutics, dissolution, pbbm
Division: PBPK

The role of biopharmaceutics risk assessment

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Simulations Plus General Overview
  • May 27, 2022
  • Presentation

Simulations Plus General Overview

Authors: Le Merdy M
Conference: GMP
Keywords: drug development, machine learning, PBPK modeling, QST modeling
Software: ADMET Predictor®, DILIsym®, GastroPlus®, IPFsym®, NAFLDsym®, RENAsym®
Division: PBPK

Our solutions inform the entire drug development process

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API Enabled HTPK Deployment of Early PK Assessments for Drug Discovery
  • May 4, 2022
  • Presentation

API Enabled HTPK Deployment of Early PK Assessments for Drug Discovery

Authors: Jamois E
Conference: IKTOS
Keywords: admet predictor, api, drug discovery, gastroplus, HTPK deployment
Software: ADMET Predictor®
Division: PBPK

Mechanistic High-Throughput PK

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Your #1 Ranked Team for Exposure and Safety Solutions!
  • March 28, 2022
  • Presentation

Your #1 Ranked Team for Exposure and Safety Solutions!

Authors: Howell BA, DiBella J
Conference: SOT
Keywords: model-informed drug development, Modeling and simulations, research and development, toxicokinetics
Software: ADMET Predictor®, DILIsym®, GastroPlus®, RENAsym®
Division: PBPK, Quantitative Systems Pharmacology (QSP)

Do you think modeling and simulation might help?

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Building a Machine Learning Model for Tautomer Prediction
  • March 23, 2022
  • Presentation

Building a Machine Learning Model for Tautomer Prediction

Authors: Waldman M
Conference: ACS
Keywords: admet predictor, logP, machine learning, permeability, QSAR model, solubility, tautomer
Software: ADMET Predictor®
Division: PBPK

Many drug molecules exhibit tautomerism

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AI-driven Lead Discovery
  • March 20, 2022
  • Presentation

AI-driven Lead Discovery

Authors: Lawless M, Miller D, Waldman M
Conference: ACS
Keywords: admet predictor, AI-driven compound optimization, AIDD Module, BACE1 inhibitors, de novo design
Software: ADMET Predictor®
Division: PBPK

Computer based de novo drug design background

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Patient-Centric Design of Long-Acting Injectable Drug Products
  • March 9, 2022
  • Presentation

Patient-Centric Design of Long-Acting Injectable Drug Products

Authors: Lukacova V
Conference: AAPS
Keywords: drug products, in vivo dissolution, long-acting injectable formulations, PBPK model
Division: PBPK

PBPK model description

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Current status and gaps in mechanistic in-silico modeling for clinical translation and performance
  • March 9, 2022
  • Presentation

Current status and gaps in mechanistic in-silico modeling for clinical translation and performance

Authors: Lukacova V
Conference: AAPS
Keywords: active pharmaceutical ingredient (API), clinical translation & performance, in silico, PBPK model
Software: GastroPlus®
Division: PBPK

Exploring mechanisms affecting in vivo dissolution of low-solubility compound crystalline suspensions

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Post-Approval/Generics Track: Pushing the Boundaries Beyond – NextGen Session Panel Discussion and Live Q&A
  • February 17, 2022
  • Presentation

Post-Approval/Generics Track: Pushing the Boundaries Beyond – NextGen Session Panel Discussion and Live Q&A

Conference: SLP MIDD+
Keywords: MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, Post-Approval/Generics Track, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Q&A presented at SLP MIDD+ Virtual Conference February 16th-17th, 2022

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Post Approval: Generics Track – Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and CBD using Quantitative Systems Toxicology (QST)
  • February 17, 2022
  • Presentation

Post Approval: Generics Track – Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and CBD using Quantitative Systems Toxicology (QST)

Authors: Lakhani VV
Conference: SLP MIDD+

Presented by Vinal Lakhani at SLP MIDD+ Virtual Conference February 16th-17th, 2022

  • Read More
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Clinical Track: Pushing the Boundaries Beyond – NextGen Session Panel Discussion and Live Q&A
  • February 17, 2022
  • Presentation

Clinical Track: Pushing the Boundaries Beyond – NextGen Session Panel Discussion and Live Q&A

Conference: SLP MIDD+
Keywords: Clinical Track, MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Q&A presented at SLP MIDD+ Virtual Conference February 16th-17th, 2022

  • Read More
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Clinical Track Poster Presentation: Count data model for Alzheimer disease progression MMSE score using MonolixSuite®
  • February 17, 2022
  • Presentation

Clinical Track Poster Presentation: Count data model for Alzheimer disease progression MMSE score using MonolixSuite®

Authors: Traynard P
Conference: SLP MIDD+
Keywords: Alzheimers, Clinical Track, MIDD (model-informed drug development), MIDD+ 2022, MMSE, modeling and simulation, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Presented by Pauline Traynard at SLP MIDD+ Virtual Conference February 16th-17th, 2022

  • Read More
  • Click to View
Post-Approval/Generics Track Poster Presentation: Use of PBBM to Establish Dissolution Safe Space via IVIVR for Concor®
  • February 17, 2022
  • Presentation

Post-Approval/Generics Track Poster Presentation: Use of PBBM to Establish Dissolution Safe Space via IVIVR for Concor®

Authors: Macwan J
Conference: SLP MIDD+
Keywords: Concor, MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, pbbm, PBBM modeling, Post-Approval/Generics Track, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Presented by Joyce Macwan at SLP MIDD+ Virtual Conference February 16th-17th, 2022

  • Read More
  • Click to View
Post-Approval/Generics Track Poster Presentation: Relationship between Pimavanserin Exposure and QTc Interval in Patients with Schizophrenia: Modelling Analysis from Randomized, Double-Blind, Placebo-Controlled Studies
  • February 17, 2022
  • Presentation

Post-Approval/Generics Track Poster Presentation: Relationship between Pimavanserin Exposure and QTc Interval in Patients with Schizophrenia: Modelling Analysis from Randomized, Double-Blind, Placebo-Controlled Studies

Authors: Huang H
Conference: SLP MIDD+
Keywords: MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, pimavanserin, Placebo-Controlled Studies, Post-Approval/Generics Track, QTc, schizophrenia, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Presented by Hannah Huang at SLP MIDD+ Virtual Conference February 16th-17th, 2022

  • Read More
  • Click to View
Post-Approval/Generics Track Poster Presentation: Therapeutic Drug Monitoring for Tyrosine Kinase Inhibitors. Possibilities, difficulties, and challenges
  • February 17, 2022
  • Presentation

Post-Approval/Generics Track Poster Presentation: Therapeutic Drug Monitoring for Tyrosine Kinase Inhibitors. Possibilities, difficulties, and challenges

Authors: Chauvin J
Conference: SLP MIDD+
Keywords: MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, Post-Approval/Generics Track, SLP MIDD+ Virtual Conference, SLP2022MIDD, therapeutic drug monitoring, Tyrosine Kinase Inhibitors
Division: PBPK

Presented by Jonathan Chauvin at SLP MIDD+ Virtual Conference February 16th-17th, 2022

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  • Click to View
Clinical Track Poster Presentation: Clinical Ocular Exposure Extrapolation Using PBPK Modeling & Simulation: Levofloxacin Solution Case Study
  • February 17, 2022
  • Presentation

Clinical Track Poster Presentation: Clinical Ocular Exposure Extrapolation Using PBPK Modeling & Simulation: Levofloxacin Solution Case Study

Authors: Le Merdy M
Conference: SLP MIDD+
Keywords: Clinical Track, levofloxacin, MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Presented by Maxime LeMerdy at SLP MIDD+ Virtual Conference February 16th-17th, 2022

  • Read More
  • Click to View
Clinical Track: Yo-Yo Dieting Predicted to Contribute to Fibrosis Score Reductions in Untreated (Placebo) Cohorts
  • February 17, 2022
  • Presentation

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

Authors: Shoda LKM
Conference: SLP MIDD+
Keywords: Clinical Track, MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, SLP MIDD+ Virtual Conference, SLP2022MIDDConference: SLP MIDD+, untreated cohorts, yo-yo dieting
Division: PBPK

Presented by Lisl Shoda at SLP MIDD+ Virtual Conference February 16th-17th, 2022

  • Read More
  • Click to View
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