Saturday 28 November 2020

FDA new guidance: Physiologically based pharmacokinetic analyses


A new FDA draft guidance has been issued: ‘The use of physiologically based pharmacokinetic analyses — biopharmaceutics applications for oral drug product development, manufacturing changes, and controls’.


This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by sponsors of investigational new drug applications, and applicants for new drug applications, or abbreviated new drug applications, and supplements to these applications, for oral drug product development, manufacturing changes, and controls. 



PBPK analyses use models and simulations that combine physiology, population, and drug substance and product characteristics to mechanistically describe the pharmacokinetic (PK) and/or pharmacodynamic behaviors of a drug product. Although the pharmaceutical industry has in some cases been successful in developing in vitro/in vivo correlations (IVIVCs) to support biowaiver requests in lieu of in vivo BE studies for major manufacturing changes, development of an adequate IVIVC for regulatory submission remains challenging. FDA recognizes this challenge and encourages the development and use of new tools and approaches for linking pharmaceutical quality to clinical performance.


Advances in modelling and simulation have enabled the integration of factors such as the physicochemical properties of the active pharmaceutical ingredient (API), dissolution data, and the physiology of the GI tract into the development of PBPK models. As such, PBPK modeling has become a promising tool in predicting systemic drug exposure  and has been used for dose selection, food effect assessment, and drug interaction potential evaluation.


For details, see:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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