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.
- Learn the essential activities and regulatory requirements involved in Phase 0 and Phase I clinical trials
- Understand how bioequivalence, maximum tolerated dose, and dose escalation strategies influence go/no-go decisions
- Explore the reasoning behind combining trial phases when developing treatments for rare diseases
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- Overview
- Agenda
- Features
- Justify This Training
- FAQ
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Agenda
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Clinical Trial Prerequisites
Identifies the CMC, preclinical safety, and pharmacology prerequisites for entering early-phase clinical trials.
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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.
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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
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