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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.

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Clinical Development 201: Phase I Course Trailer

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

Clinical Development 201 Phase I Agenda
Course Price:
$150 USD
BIO Member Price:
$120 USD
Course Length:
55 minutes
Course Level:
Intermediate
Completion Period:
2 weeks
Course Format:
On-Demand

Certificate Requirements

  • View the entire course  
  • Pass course exam with a 70 percent  
  • Complete the course evaluation  
Suggested Prerequisites
FLIP

Clinical Development 101: General Principles sets the stage for the entire clinical development process. Learn who conducts trials, how trials are conducted, and the various regulatory elements that must be performed throughout Phases I-IV trials.

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