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The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review
Author(s) -
Huang SM,
Rowland M
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2011.320
Subject(s) - clinical pharmacology , physiologically based pharmacokinetic modelling , pharmacology , pharmacokinetics , drug , license , safety pharmacology , molecular pharmacology , medicine , computational biology , computer science , biology , receptor , operating system
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. Clinical Pharmacology & Therapeutics (2012); 91 3, 542–549. doi: 10.1038/clpt.2011.320