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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.

Features

  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates

FAQ

  • How long do I have to complete an on-demand course?  You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
  • What happens if I don’t complete the course in one year?  There are no time extensions. If you want to complete the course, you must purchase it again.
  • How long are the on-demand classes?  Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes.  The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
  • Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
  • What is the format of the on-demand classes?  The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
  • Can I repeat the course?  You can repeat the course as often as you like within your one-year access.
  • How many times can I take the course quiz?  You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
  • May I share a course I purchased with others?  Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.

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