CLI 8551 'Drug Development - from Bench to Bedside
This course will provide students the knowledge, skills and perspectives on pre-clinical and clinical drug development with an emphasis on interventional clinical trials. Major topics include preclinical testing, introduction to pharmacokinetics and modeling, GMP facilities, regulatory aspects of human subjects research, operations and management of clinical research teams, overview of clinical trials management systems and case report forms, endpoints and statistical considerations, protocol and consent documents.