Clinical Development 201: Phase I explains the purpose of Phase I and the regulatory roles of the FDA, IRB, and EMA. Class highlights include how data from bioequivalence, pharmacokinetics, and pharmacodynamics studies are used to assess the success of Phase I endpoints. The last section explores how the single ascending dose and multiple ascending dose protocols help refine patient dosage schedules.
Suggested Prerequisites
Clinical Development 101: General Principles
Certificate Requirements
- View the entire course
- Pass course exam with a 70 percent
Certificate Requirements
- View the entire course
- Pass course exam with a 70 percent
02 Clinical Development 201: Phase I
Section 1: Clinical Trail Prerequisites
Clinical Trial Prerequisites identifies the CMC, preclinical safety, and pharmacology prerequisites for entering early phase clinical trials. Learn th...More
Section 2: Study Designs and Objectives
Study Designs and Objectives describes the purpose of, and characteristics of Phase 0 and Phase I clinical trials and the general approach associated...More
Section 3: Conducting the Clinical Study
Phase I Conducting the Clinical Study explains how dosage is determined using maximum tolerated dose (MTD), single ascending dose (SAD), and multiple...More
Certificate Requirements
- View the entire course
- Pass course exam with a 70 percent