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 Category: Pharmaceutical Sciences

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.
1:20
In the next several slides, I will describe the different centers within FDA and describe their function.
1:28
In the United States, it is illegal to test new drugs in humans or to market new drugs for human use without having approval from the FDA. FDA is responsible for ensuring that clinical trials are safely conducted and that safe and efficacious drugs are approved for marketing.
Hide

General introduction to non-clinical toxicity testing of pharmaceuticals

Embed in course/own notes