Exposure-Response FDA Guidance (Ep. 10)
Exposure-Response FDA Guidance (Ep. 10)
Exposure-Response FDA Guidance (Ep. 10)
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
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Clinical Pharmacology Podcast with Nathan Teuscher
I discuss clinical pharmacology and pharmacometrics topics from the perspective of drug development scientists. I share my expertise and knowledge about designing and conducting clinical pharmacology studies and discuss how to analyze the data using the most effective approaches. I draw from my experience of over 20 years working in drug development organizations and consultancies.Join Podchaser to...
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