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  3. Exposure-Response FDA Guidance (Ep. 10)

Exposure-Response FDA Guidance (Ep. 10)

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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”
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Exposure-Response FDA Guidance (Ep. 10)
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Exposure-Response FDA Guidance (Ep. 10)
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