Physiology Based Pharmacokinetic Modeling in Generic Drug Development and Regulatory Decisions- Opportunities & Challenges

Authors: Sanghavi M
Software: GastroPlus®
Division: PBPK

Physiology based pharmacokinetic (PBPK) modeling is widely used within the pharmaceutical industry to predict oral drug absorption. The potential utility of PBPK absorption modeling in the regulatory setting has been highlighted by both industry and regulators. A recent survey of the pharmaceutical industry highlighted that in silico PBPK absorption modeling is widely used during development to address a variety of biopharmaceutics issues. Application of PBPK modeling to support clinically relevant specifications has been encouraged by various regulatory agencies.

A sequential process of implementing PBPK modelling and simulation at various steps of generic drug product development is discussed. Various quintessential points are explained with relevant examples, and how PBPK modeling can accelerate the drug development process is highlighted. Further, challenges and ‘keep in mind’ points are discussed with regulatory filing perspectives.

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