Clinical Development 201: Phase I

Clinical Development 201: Phase I provides insights into Phase 0 and Phase I clinical trials, including their purpose and regulatory requirements. This class, the second in the Biotech Primer Clinical Development series, showcases the indispensable role of gathering preliminary pharmacokinetics and pharmacodynamics data to determine the appropriate dosage of experimental treatments. Strategies of Single Ascending Dose (SAD), Multiple Ascending Doses (MAD), and Maximum Tolerated Dose (MTD) protocols are explained in thorough detail. Clinical Development 201 outlines how researchers vigilantly monitor participants, meticulously collect
vital safety data, and expertly evaluate the effectiveness of new treatments using well-defined endpoints. Don’t miss this opportunity to enhance your clinical trials expertise. Enroll now to secure your seat!

Section 1: Clinical Trial Prerequisites

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.

Section 2: Phase 0/I 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 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.

Section 3: Phase I 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 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.

Five Takeaways


  1. Evaluate the purposes and critical differences between Phase 0 and Phase I clinical trials.
  2. Understanding of protein synthesis and how this cellular process is optimized to create therapeutics.
  3. Compare the dosing strategies of Single Ascending Dose (SAD) and Multiple Ascending Doses
    (MAD) and explain when each is employed.
  4. Describe the vital steps sponsors take upon completion of Phase I clinical development.
  5. Emphasize the significance of Clinical Trial Safety Reports in evaluating the safety and overall
    success of Phase I clinical trials.

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