Clinical Trial Prerequisites identifies the CMC, preclinical safety, and pharmacology prerequisites for entering early phase clinical trials. Learn the requirements needed for the IND application and how ethics committees and Institutional Review Boards (IRBs) must review the protocols prior to a drug entering humans for the first time....Less

Study Designs and Objectives describes the purpose of, and characteristics of Phase 0 and Phase I clinical trials and the general approach associated with bioequivalence studies. Compare and contrast the expectations related to clinical benefit in early clinical trials for a) standard development programs, and b) development of treatments for conditions associated with serious unmet medical needs....Less

Phase I Conducting the Clinical Study explains how dosage is determined using maximum tolerated dose (MTD), single ascending dose (SAD), and multiple ascending dose (MAD), pharmacokinetics, and pharmacodynamics data. Become familiar with typical endpoints assessed in Phase I clinical trials and learn how and why clinical trial phases are sometimes combined. This section also describes the requirements for Clinical Trial Safety Reports associated with adverse events and what steps take place at the conclusion of the clinical study....Less