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General introduction to non-clinical toxicity testing of pharmaceuticals
A selection of talks on Pharmaceutical Sciences
RNA therapeutics: clinical applications and methods of delivery
- Prof. John P. Cooke
- Houston Methodist Research Institute, USA
Overview of nonclinical safety assessment
- Dr. Claudette L. Fuller
- Merck Research Laboratories, USA
Drug-induced liver injury: risk factors and drug development in DILI
- Prof. James H. Lewis
- Georgetown University Medical Center, USA
Drugging conformational states of GPCRs
- Prof. Dr. Peter Kolb
- Philipps-Universität Marburg, Germany
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.
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.
In the next several slides, I will describe the different centers within FDA and describe their function.
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.