Empowering professionals for over 24 years

Empowering professionals for over 24 years

Clinical Development 201: Phase I  | CPE

Clinical Development 201: Phase I  | CPE
  • Level: Intermediate
  • CPE: 1.0 Credits
  • Time: 50 Minutes

Explore how early trials drive smart drug development with Clinical Development 201: Phase I. Compare pharmacology data, dose escalation, and safety monitoring differences in standard vs. fast-track programs—key insights for reducing risk and maximizing ROI.

  1. Learn the essential activities and regulatory requirements involved in Phase 0 and Phase I clinical trials
  2. Understand how bioequivalence, maximum tolerated dose, and dose escalation strategies influence go/no-go decisions
  3. Explore the reasoning behind combining trial phases when developing treatments for rare diseases
  • Best Value: Unlimited Learning
  • Purchase Single Course

Choose your subscription and start exploring a rich library of expert led, on-demand biotech training.

  • Up to 12-month unlimited access
  • Content designed for all skill levels: Beginner to Advanced
  • CPE credits included with every course
  • Learn at your own pace
  • Choose the subscription plan that fits your goals

Get full access to this course with a one time purchase.

  • 1-month access to all course material
  • CPE credits included
  • No subscription required
  • Self-paced and on-demand
  • Ideal for focused, one-off learning
  • Overview
  • Agenda
  • Features
  • Justify This Training
  • FAQ

Watch Trailer

Agenda

  1. Clinical Trial Prerequisites

    Identifies the CMC, preclinical safety, and pharmacology prerequisites for entering early-phase clinical trials.

  2. Phase 0/I: Study Designs and Objectives

    Describes the purpose and process of Phase 0 and Phase I study designs focusing on bioequivalence studies for standard development programs and serious unmet medical needs programs.

  3. 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 required for Clinical Trial Safety Reports.

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

Justify This Training

View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.

FAQ

Whom should I contact if I have a question about an on-demand course or a program?
What are my options for purchasing on-demand courses?
Who takes Biotech Primer courses?
What is the format of an on-demand course?
How long are the on-demand courses and programs?
How long do I have to complete a course?
Can I repeat a course or program?
What happens if I don’t finish the course or program in time?
How many times can I retake the course quiz?
Will I receive a certificate after completing the Microcourse or Deep Dive program?
Do I receive Continuing Professional Education (CPE) Credits?
What are NASBA-approved Continuing Professional Education (CPE) Credits?
Do you offer course materials to download?
Are Microcourses and Deep Dive programs available in other languages?
Can I share my course with others?
What if I need training on a topic not listed on your website?

WHAT PEOPLE ARE SAYING

No testimonials found.

Stay Informed: Get the Latest Blog Updates!

Understand the Science Behind Biotech So You Can Lead, Advise, and Strategize With Clarity.

Unlock Your Biotech