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Clinical Pharmacology Podcast with Nathan Teuscher

Pediatric Extrapolation (Ep. 7)

25 min • 14 augusti 2023

Thank you to everyone who sent me feedback on this podcast. This episode is based on a suggestion from Kushal and Parmesh. In this episode, I discuss a general clinical pharmacology pediatric extrapolation plan. I describe the basics of the plan that is commonly proposed to regulatory bodies. I discuss specific technical approaches for extrapolation of adult pharmacokinetic data to pediatric patients and the extrapolation of adult exposure-response or pharmacodynamic data to pediatrics. And I conclude with a discussion of how to use physiologic-based pharmacokinetic models for pediatric extrapolation.


Links discussed in the show:

Baby arms over head video

PBPK Models in Pediatric Development

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