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Webinar: Physiology Based Pharmacokinetic Modeling in Generic Drug Development and Regulatory Decisions- Opportunities and Challenges
April 29, 2019 @ 10:30 pm - 11:30 pm
Physiology Based Pharmacokinetic Modeling in Generic Drug Development and Regulatory Decisions- Opportunities and Challenges
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 was performed. Various quintessential points were explained with relevant examples and light has been thrown on how PBPK modeling can fasten drug development process. Further, challenges and ‘keep in mind’ points were discussed with regulatory filing perspectives.
Maitri Sanghavi, MS (Pharma),
Cadila Healthcare Ltd. India.