Epidiolex (highly purified CBD) is efficacious in treating seizures associated with Dravetsyndrome (DS), Lennox-Gastautsyndrome (LGS), and Tuberous Sclerosis Complex (TSC)
Quantitative Systems Toxicology (QST) to Investigate Mechanisms Contributing to Clinical Bilirubin Elevations
Some patients treated with Drug X experienced elevations in serum bilirubin with concomitant ALT elevations, potentially indicative of severe liver injury.
Quantitative systems toxicology (QST) to investigate mechanisms contributing to clinical bilirubin elevations
To be presented at the FDA/CDER and AASLD 2021 DILI Conference XVIII. Quantitative systems toxicology (QST) to investigate mechanisms contributing to clinical bilirubin elevations: Some patients treated with Drug X experienced clinically relevant elevations in serum bilirubin with concomitant ALT elevations, indicative of potentially severe liver injury (Hy’s Law cases). However, the interpretation is complicated if there is evidence that a compound directly alters bilirubin disposition, leading to bilirubin elevations absent liver injury. Distinguishing between these two possibilities is critical to inform drug development decisions. DILIsym, a QST platform of drug-induced liver injury (DILI), was used to investigate the interpretation of putative Drug X-related elevations in liver biomarkers.
Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and (CBD) using Quantitative Systems Toxicology (QST)
To be presented at the FDA/CDER and AASLD 2021 DILI Conference XVIII. Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and (CBD) using Quantitative Systems Toxicology (QST). We aimed to identify the mechanism(s) accounting for the higher incidence of ALT elevation observed in individuals treated with VPA and CBD by using a Quantitative Systems Toxicology (QST) model of hepatotoxicity (DILIsym®) to test the hypothesis that increased incidence of ALT elevation was due to VPA and CBD (or metabolites of each) inhibiting mitochondrial respiration.
The Future of Clinically Relevant Dissolution Testing and Physiologically Based Biopharmaceutics Modeling (PBBM/PBPK) in Drug Product Development, Manufacturing Changes and Controls
Regulatory applications of dissolution testing as per published FDA guidance...
OPCO Fireside Chat
Slides from the OPCO Fireside Chat
AAPS VCU Chapter Webinar
GastroPlus applications to various drug delivery routes of administration.
Novel Clinical Trial Designs for Optimizing Parameter Estimation in Malaria Disease-Drug Models
An introduction to Model-Informed Drug Development (MIDD) for Malaria and Volunteer Infection Studies (VIS)
Hepatotoxicity of Compound V Evaluated with Quantitative Systems Toxicology
Compound V is a small molecule with potential therapeutic benefits in patients with obesity.
Quantitative Systems Toxicology (QST) Modeling of Drug-Induced Liver Injury and Adaptation
This talk will present how quantitative systems toxicology (QST) modeling can aid in evaluating potential drug-drug interactions.
Prediction of midazolam pediatric plasma profiles for multiple routes of administration using physiologically based pharmacokinetic model
Owing to ethical and logistical constraints, clinical investigation of drugs in the pediatric population is challenging.
Utilization of PBBM/PBPK Models for Building a Safe Space and Regulatory Applications in Support of Drug Product Quality
Drug products undergo many chemistry, manufacturing, and control (CMC) changes throughout their lifecycle, making the overall process costly and time consuming.
DILIsym: Modeling Drug-Induced Liver Injury & Beyond
DILIsym Services, Inc. (DSSI) is a Simulations Plus company...
QST Applications, Use of Data and Species Differences
DILIsym Services, Inc. (DSSI) is a Simulations Plus company..
DILIsym Simulations Support the Liver Safety of Ubrogepant in New Toxicological Sciences Publication
Dr. Paul B. Watkins and Dr. Jeff Woodhead discuss the DILIsym analysis of the latest publication in Toxicological Sciences! Small-molecule calcitonin gene...
Modeling DILI Drug-Drug Interactions with DILIsym
DILIsym Services, Inc. offers comprehensive program services:
Physiologically Based Biopharmaceutics Modeling and Virtual Bioequivalence Assessment to Support Formulation Development
Mechanistic Absorption and PK modeling using GastroPlus®