Clinical Development 201: Phase I

  • Course Price: $150 USD
  • BIO Member Price: $120 USD
  • Course Run Time: 50 minutes
  • Course Level: Level 2 - General
  • Completion Period: 2 week

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

 
Takeaways
  1. Requirements for and maintenance of an Investigational New Drug (IND) application and a Clinical Trials Application (CTA).
  2. Purpose of, and characteristics of Phase 0 and Phase I clinical trials.
  3. 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.
  4. Typical endpoints assessed in Phase I clinical trials.
  5. Steps to take at the conclusion of the Phase I clinical study.
 
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  
Trailer
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
Final Quiz
LinkedIn Certificate Demo
Certificate Requirements
  • View the entire course  
  • Pass course exam with a 70 percent