The role of physiologically based pharmacokinetic modeling in regulatory review.
During regulatory review of clinical pharmacology data in new drug applications and biologics license applications, questions are routinely asked about how intrinsic factors (e.g., organ dysfunction, age, and genetics) and extrinsic factors (e.g., drug-drug interactions) might influence dose-response and exposure-response and about the impact of these individual factors on the efficacy and safety of the candidate compound. Physiologically based pharmacokinetic (PBPK) modeling and simulation is one of the tools that can be used to address these critical questions.
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. ShiewMei.Huang@fda.hhs.gov
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D003198:Computer Simulation; D004347:Drug Interactions; D004335:Drug and Narcotic Control / Q000379:methods*; D006801:Humans; D017387:Investigational New Drug Application; D008954:Models, Biological; D010599:Pharmacokinetics; D010601:Pharmacology, Clinical; D010827:Physiology; D018570:Risk Assessment