Sep 07 2014

The “no observable adverse effect level” (NOAEL) has been used for communicating results of animal data to clinicians and regulators. For biotechnology-derived therapeutics, effects observed in preclinical studies are often the result of intended exaggerated pharmacology, therefore identifying ADVERSITY and a NOAEL can be a challenging and controversial endeavor.

This interactive workshop is intended to discuss the concepts of adversity and NOAEL, and their application using a case-based approach on a variety of controversial drug development scenarios, so that participants can share and learn from their collective experiences.