Preclinical Animal Models: Selection & Rationale

This lecture covers the selection and rationale behind preclinical animal models in drug development, focusing on the 10 to 15-year path to a marketed small-molecule drug. It discusses the timeline of preclinical studies, clinical trials, and FDA approval, emphasizing the importance of the 3Rs principle in animal research. The lecture explores the complexity of species used in preclinical models, the validity scoring systems, and the practical application of different models at various stages of drug discovery. It also delves into the challenges of reproducibility in preclinical research and the need for improved methodologies to predict human toxicities. Case studies involving zebrafish and fruit fly models are presented to illustrate the potential of these models in drug discovery.