Non-Clinical Testing for Toxicity of PharmaceuticalsRegulatory and Practical Standards for Testing and Application

Published July 2009 Updated December 2016 23 lectures
Dr. Jeanine Bussiere
Amgen Inc, USA
Summary

Drug safety is a huge issue facing patients, prescribers, health care facilities, regulatory authorities and pharmaceutical companies. The non-clinical testing for toxicity of pharmaceuticals will be outlined and discussed in this series. Toxicity testing procedures will be described emphasizing experimental design considerations (dose and species selection, toxicokinetic criteria) as well... read moreas regulatory guidelines and impacts of global harmonization efforts. The talks will also provide insights into the risk assessment process in terms of evaluating and interpreting toxicity data relative to human safety.

This series of talks has been designed to provide an up-to-date introduction and review of the field of non-clinical toxicity testing and to cover areas pertinent to regulations, specific target organs of toxicity which are of greatest concern in pharmaceutical drug development, new methods for testing for toxicity of pharmaceutical agents and differences in toxicity testing for certain types of pharmaceuticals.