Well integrated teams of scientists from across all drug discovery and development departments, communicating effectively, are necessary for successfully solving complex scientific problems that arise in the development of new drugs. The registration of the anti HIV AIDS drug efavirenz is an excellent example of this hypothesis-driven teamwork. Expertise from toxicologists, DMPK scientists, and synthetic chemists was crucial in defining the issues clearly, developing tools for insightful experiments, and driving the science supporting the conclusions. The strategy and experiments ultimately identifying the reactive metabolite responsible for the species-specific nephrotoxicity observed in rats dosed with efavirenz provide a framework for addressing nonclinical toxicities and clinical risk and providing a solid scientific basis for regulatory review.
Elsevier, Overcoming Obstacles in Drug Discovery and Development
Surmounting the Insurmountable—Case Studies for Critical Thinking
2023, Pages 215-222
