CDER published a survey article in February 2019 giving a capsule description of the application of Physiologically Based Pharmacokinetic Modeling (PBPM) in modern drug development. The article presents one of the nicest visuals for PBPM I’ve seen and goes on to describe the work of CDER pharmacologists to use these predictive models to support regulatory decision making. The publications list and links to guidance at the end of the article offer a helpful and current set of references on the use of this tool to support INDs and NDAs.

Text Copyright © 2019 Katrina Rogers