Pediatric Extrapolation (Ep. 7)

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 • 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