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.
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.
Regulatory applications of dissolution testing as per published FDA guidance...
Slides from the OPCO Fireside Chat
GastroPlus applications to various drug delivery routes of administration.
An introduction to Model-Informed Drug Development (MIDD) for Malaria and Volunteer Infection Studies (VIS)
Compound V is a small molecule with potential therapeutic benefits in patients with obesity.
This talk will present how quantitative systems toxicology (QST) modeling can aid in evaluating potential drug-drug interactions.
Owing to ethical and logistical constraints, clinical investigation of drugs in the pediatric population is challenging.
Drug products undergo many chemistry, manufacturing, and control (CMC) changes throughout their lifecycle, making the overall process costly and time consuming.
DILIsym Services, Inc. (DSSI) is a Simulations Plus company...
DILIsym Services, Inc. (DSSI) is a Simulations Plus company..
Dr. Paul B. Watkins and Dr. Jeff Woodhead discuss the DILIsym analysis of the latest publication in Toxicological Sciences! Small-molecule calcitonin gene...
DILIsym Services, Inc. offers comprehensive program services:
Mechanistic Absorption and PK modeling using GastroPlus®
Our mission is to improve the productivity of science-based research & development enterprises by delivering innovative modeling and simulation software and insightful consulting services
Simulations Plus to Present at the 22nd Annual Needham Growth Conference