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Prediction of Safety: An Evolving Field for Selecting Low-Risk Compounds Towards an Effective Life Cycle of a Product
Session Chair(s)
Pradip Paul, MD, MS
Consultant, Strategic Pharmacovigilance and Risk Management, United States
Using Virtual Population Simulation to Generate Insights on Drug Performance in Special Populations
Learning Objective : Discuss the recent technical advancements in predicting safety of a compound under development; Judge the level of a possible safety risk in late-stage development or after marketing; Utilize strategic planning in selecting an ideal candidate in drug development with low safety risk.
Speaker(s)
Badri Rengarajan, MD
Life Sciences, Jazz Pharmaceuticals, United States
Using Virtual Population Simulation to Generate Insights on Drug Performance in Special Populations
Keith K. Burkhart, MD
Senior Advisor for Medical Toxicology, DARS, OCP, OTS, FDA, United States
Stevens Johnson Syndrome: Mechanistic Insights
Mark Avigan, MD
Associate Director for Critical Path Initiatives, OPE, OSE, CDER, FDA, United States
Prediction of Drug Induced Liver Injury (DILI)
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