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®
Annual Shareholders’ Meeting
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
Simulations Plus to Present at the 22nd Annual Needham Growth Conference
LD Micro 12th Annual Main Event Investor Conference
Our mission is to improve the productivity of science-based research & development enterprises by delivering innovative modeling and simulation software and insightful consulting services
QSP/QST Modeling Support for NASH Drug Development
Quantitative Systems Pharmacology (QSP) Supports Clinical Development by Emphasizing Mechanistic Understanding of Pathophysiology and Treatment
Benchmark 8th Annual Discovery Conference
Our mission is to improve the productivity of science-based research & development enterprises by delivering innovative modeling and simulation software and insightful consulting services
Mechanistic Insights into Drug-Induced Liver Injury for Macrolide Antibiotics using Quantitative Systems Toxicology Modeling
DILIsym Services Is Using QSP and QST Modeling to Predict Efficacy and Safety of Drugs in Development
Development of Drugs to Treat NAFLD/NASH using Quantitative Systems Pharmacology Modeling
This session will provide scientific background and overview of the application of quantitative systems pharmacology (QSP) modeling in drug development to treat NALFD/NASH
Different Perspectives – Informing Drug Development Decision Making Through Complementary M&S Approaches
Although fundamental principles are different between PBPK and population PK approaches, both techniques have been used to study drug disposition during drug development.
Mechanistic PBPK modeling of special population groups – considerations and opportunities
Unwarranted studies, due to the general nature of regulatory guidelines, may be avoided.
Utilizing DILIsym, a QST Platform, to Extract More from Your Data to Support Decisions
Recently Completed Clinical Trial Indicates that DILIsym Backup Compound Predictions Were Correct
New approach to regression uncertainty analysis and applications to drug design
When can you trust a decision/prediction from a machine learning model?
Using Quantitative Systems Toxicology (QST): Improving the Safety of Drugs While Reducing Animal Testing
QST modeling is having a significant impact on decision making in drug development.
How to obtain biowaivers for clinical trials using PBPK models, two case studies
FDA is open to proposals of using modeling approaches for bioequivalence (BE), or for new drugs,with the proper justification and model verification