Dr. Marc Lefebvre, B. Pharm., M.Sc., PhD. Vice President, Scientific & Regulatory Affairs, Algorithme Pharma.
This presentation examines study design considerations used in developing efficient FIH clinical trials. With the recent trends evolving in drug development models, FIH study design considerations typically now include sponsor objectives, regulations, type of compounds and timelines. However, external factors such as formulations, bioanalytical methods, study population and safety events can have a significant study design impact. In this session, we use a case study analysis to discuss the development of efficient study designs while accounting for standard considerations and external factors. Presented at The Science Exchange Symposium, February 27th, 2014 in Montreal, Quebec, Canada.