BIO Professional Development
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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!
Takeaways
- Evaluate the purposes and critical differences between Phase 0 and Phase I clinical trials.
- Enumerate the types of endpoints used to assess efficacy in Phase I studies.
- Compare the dosing strategies of Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) and explain when each is employed.
- Describe the vital steps sponsors take upon completion of Phase I clinical development.
- Emphasize the significance of Clinical Trial Safety Reports in evaluating the safety and overall success of Phase I clinical trials.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
Gain foundational knowledge on clinical development: trial conduct, design principles, GCPs, & trial phases I-IV.
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