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Exposure-Response FDA Guidance (Ep. 10)
Exposure-Response FDA Guidance (Ep. 10)
ratings:
Length:
25 minutes
Released:
Sep 25, 2023
Format:
Podcast episode
Description
This episode is a discussion of the FDA guidance “Exposure-Response Relationships”. The relationship between drug exposure and response is critical to any determination of the safety and effectiveness of a drug product. In this episode I discuss the regulatory applications of exposure-response, the exposure-response relationships over time, the design of studies to collection exposure-response information, and modeling exposure-response relationships.
Links discussed in the show:
• FDA guidance “Exposure-Response Relationships”
• ICH E4 guideline “Dose-Response Information”
• You can connect with me on LinkedIn and send me a message
• Send me a message
• Sign up for my newsletter
Copyright Teuscher Solutions LLC
All Rights Reserved
Links discussed in the show:
• FDA guidance “Exposure-Response Relationships”
• ICH E4 guideline “Dose-Response Information”
• You can connect with me on LinkedIn and send me a message
• Send me a message
• Sign up for my newsletter
Copyright Teuscher Solutions LLC
All Rights Reserved
Released:
Sep 25, 2023
Format:
Podcast episode
Titles in the series (24)
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