Mice to Men: Completing the Circle, the Preclinical Safety Flag to Clinical Validations
Colin Pattison, BSc
Functional Manager, Charles River
Jason W. Boggs, BSc
Senior Research Scientist, Charles River
Lauren Black, PhD
Senior Scientific Advisor, Charles River
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.