BIO Professional Development
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Clinical Development 201: Phase I
Clinical Development 201: Phase I explores the prerequisites, purpose, design, and conduct of Phase I trials. Topics such as bioequivalence, pharmacokinetics, pharmacodynamics, endpoints, selection of dose, and more are explained in detail.
Takeaways
- Requirements for and maintenance of an Investigational New Drug (IND) application and a Clinical Trials Application (CTA).
- Purpose of, and characteristics of Phase 0 and Phase I clinical trials.
- Expectations related to clinical benefit in early clinical trials for a standard development programs, and development of treatments for conditions associated with serious unmet medical need.
- Typical endpoints assessed in Phase I clinical trials.
- Steps to take at the conclusion of the Phase I clinical study.
Download Course Syllabus
Certificate Requirements
- View the entire course
- Pass course exam with a 70 percent
- Complete the course evaluation
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