Population PK FDA guidance (Ep. 4)
Description
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
• 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
Today’s show is about different work environments and not scientific topics. Throughout my career I have worked in many different types of companies, and I would like to share some observations with you from those experiences. I have held positions at startup companies or small biotechnology...
Published 05/27/24
Today’s show discussed biosimilar development from a clinical pharmacology perspective. I describe what biosimilar products are and the necessary comparisons to the reference product. I review requirements for PK similarity, PD similarity, immunogenicity, and safety. I also touch on the idea of...
Published 05/13/24