Population PK FDA guidance (Ep. 4)

Released Monday, 3rd July 2023

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Population PK FDA guidance (Ep. 4)

Monday, 3rd July 2023

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In this episode, I discuss the 2022 FDA Guidance on Population PK analysis. This includes a discussion of the applications, methods, and submission requirements for population PK models.

Links discussed in the show:

• FDA Population PK Guidance

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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.

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