This webinar highlights common preclinical safety flags to consider in order to assist mitigating clinical trial risk, including recommendations from both FDA and EMA guidance documents. Our scientists also discuss a tiered approach to clinical validations and tools to accelerate translation of preclinical data to the clinic through a brief overview of human PK profile projections, human equivalent dose predictions and PK/PD modeling techniques.

Presenters

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