Barriers to Unleashing the Full Potential of Model-Informed Drug Development

Author: Ping Zhao, PhD on April 24, 2019


A recent industry perspective by Jain, et al. identified barriers to unleashing the full potential of Model-informed Drug Development (MIDD). The barriers fall into two categories: the lack of acceptance by key stake holders, and the lack of consensus in standards among global regulators. In the same issue of CPT: Pharmacometrics  & Systems Pharmacology, a commentary by Madabushi and colleagues from the US FDA presents how a holistic and integrative approach under PDUFA IV may help address these issues, and calls for a critical review within the modeling and simulation community of the root cause of acceptance barrier. 

Dr. Rajanikanth Madabushi from the US Food and Drug Administration and Drs. Lokesh Jain, Larissa Wenning, and Nitin Mehrotra from Merck all sat down to discuss their articles on two episodes of PSPod to explore solutions to these challenges.

Image by Madabushi, et al. CPT Pharmacometrics Syst. Pharmacol., doi.org/10.1002/psp4.12379, is licensed under CC BY-NC 4.0. ©2018 The authors.

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