The aim of this course is to provide instruction on the basic principles of drug development, with a primary focus on the application of fundamental principles of pharmacology and toxicology to the design and conduct of early phase clinical trials. Students will become familiar with the standard safety and pharmacokinetic assessments that take place during early clinical development, as well as with proof-of-concept and proof-of-mechanism studies, evaluations of exposure- toxicity relationships and refinement of dose selection for later phase trials. In addition to actual clinical studies, the course will examine various modeling approaches that are also conducted during drug development. At the end of the course, students should understand the phases of drug development, be able to design an early phase clinical study, understand the standardized practices and ethical implications of clinical research, and be aware of some of the scientific and non-scientific career paths/roles in drug development.