General introduction to non-clinical toxicity testing of pharmaceuticals

Published on September 16, 2009 Updated on December 28, 2016   29 min

Other Talks in the Series: Non-Clinical Testing for Toxicity of Pharmaceuticals

0:00
Hello, I am Andrea Weir. I'm a toxicologist by training, and I've spent the majority of my career in drug development. I was a reviewer of non-clinical pharmacology and toxicology submissions at the US Food and Drug Administration from 1993 to 2005. In 2005, I joined Charles River Laboratories as part of a group known as Navigator Services. In that role, I provided scientific and regulatory advice to clients regarding their non-clinical development programs. In 2015, I joined ToxStrategies Incorporated as a senior consultant with the Biopharmaceutical/Pharmaceutical Practice. In this role, I assist clients with managing the scientific and regulatory challenges of their non-clinical drug development programs.
0:53
During this presentation, I will be providing an overview of the Food and Drug Administration and of drug development from the non-clinical perspective. I will be addressing potential safety concerns that could be identified in non-clinical studies, as well as considerations for using data from non-clinical studies to support safe drug development. Finally, I'll be providing information on the correlation between non-clinical and clinical toxicities.
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General introduction to non-clinical toxicity testing of pharmaceuticals

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