Toxicological Insights for the Global Pharmaceutical Industry
Welcome to TigerU! Here you will find presentations that will help you learn about Toxicology for drug development.
Introduction to U.S. FDA pre-IND meetings ─ why and when a Sponsor should consider having a meeting and how the Sponsor approaches the process.
This presentation outlines the process for dealing with adverse preclinical / nonclinical events in order to 1) optimize the chances of successful drug development, or 2) to create a scientific basis for early termination of drug development.
New drugs that penetrate the central nervous system (CNS) must undergo analysis of abuse liability potential (e.g., behavioral pharmacology, animal drug discrimination, and self-administration data). Multiple variables must be considered.
Historical and current perspectives on genetic toxicology, with commentary and slides on assay predictivity and shortcomings, regulatory guidance, and high-throughput screens to enhance preclinical drug safety.