Thursday, April 27, 2017
11:00 AM – 12:00 PM EDT

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This webinar will discuss a tiered approach to clinical validations and tools for translating preclinical data to the clinic through a brief overview of human PK profile projections, human equivalent dose predictions, and PK/PD modeling techniques. It will also highlight common preclinical safety flags to consider in order to assist mitigating clinical trial risk. Key guidance from both the FDA and EMA will be discussed, as well as options for program acceleration.

Presenters

• Colin Pattison, BSc, Functional Manager, Charles River
• Jason W. Boggs, BSc, Senior Research Scientist, Charles River
• Lauren Black, PhD, Senior Scientific Advisor, Charles River