The Four Phases of Clinical Drug Development: From First-in-Human to Post-Approval Studies

Participants will gain an understanding of the four phases of clinical drug development, from phase 1 to phase 4.  Phase 1 trials including first-in-human, single ascending dose (SAD), multiple ascending dose (MAD), drug interaction, food effect, and special population studies will be covered.  A discussion of phase 2 trials will focus on proof-of-concept trials conducted in normal healthy volunteers using experimental models and in patient samples.  A review of phase 3 trials will focus on the elements of pivotal studies.  Discussion of phase 4 trials will focus on label enhancements, secondary indications, marketing, and drug lifecycle management.