Advancing Drug Development Under the Animal Rule with Modeling and Simulation
Sarah Divito
Click below to download the infographic. Developing therapies for serious or life-threatening conditions where human efficacy trials are not ethical or feasible presents a unique set of regulatory and scientific challenges. Under the FDA’s Animal Rule, sponsors must rely on well-controlled animal studies to demonstrate efficacy, requiring a clear understanding of disease pathophysiology and established […] The post Advancing Drug Development Under the Animal Rule with Modeling and Simulation app