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Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective

Clinical Pharmacology & Therapeutics · 2015 · Vol. 97(3) · pp. 247–262

HM Jones✉(Pfizer (United States))Yuan ChenChristopher R. Gibson(United States Military Academy)Tycho Heimbach(Novartis (United States))Neil Parrott(Roche (Switzerland))SA Peters(AstraZeneca (Sweden))Jan Snoeys(Janssen (Belgium))Vijay Upreti(Amgen (United States))Ming Zheng(Bristol-Myers Squibb (United States))S D Hall(Eli Lilly (United States))

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Abstract

The application of physiologically based pharmacokinetic (PBPK) modeling has developed rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery and development. In this study, we provide a cross pharmaceutical industry position on "how PBPK modeling can be applied in industry" focusing on the strategies for application of PBPK at different stages, an associated perspective on the confidence and challenges, as well as guidance on interacting with regulatory agencies and internal best practices.

Pharmacogenetics and Drug Metabolism Analytical Chemistry and Chromatography Statistical Methods in Clinical TrialsPhysiologically based pharmacokinetic modellingPharmaceutical industryPerspective (graphical)Drug developmentDrug discoveryManagement sciencePharmaceutical sciencesPharmacokineticsComputer scienceDrug