title: The successes and failures of physiologically based pharmacokinetic modeling: there is room for improvement.
abstract: From the year 2000 onwards, physiologically based pharmacokinetic (PBPK) models in the field of drug research and development have been increasingly used. This proliferation of applications was prompted by the availability of new data and computational approaches required for the parameterization of PBPK models, as well as the availability of commercial software platforms. PBPK approaches have been used to predict drug pharmacokinetics in humans based on nonclinical data, the potential for drug-drug interactions and the expected changes in the pharmacokinetics in case of different physiopathological conditions. In this respect, PBPK is also assuming a more important role in regulatory submissions. Although PBPK methodologies are not perfect yet, their continuous and consistent application is providing a more profound understanding of the determinants of the drug absorption and disposition of new and candidate drugs. We are confident that, with increased use, PBPK methodologies will gradually improve in their predictive capabilities.
authors: Quantitative Sciences/Model-Based Drug Development, Janssen Pharmaceutical Companies of Johnson & Johnson, c/o Janssen Cilag S.p.A. , Via M. Buonarroti 23, 20093 Cologno Monzese (MI) , Italy +39 340 303 4178 ; +39 022 510 319 ; ipoggesi@its.jnj.con.
authors: Italo
authors: I
authors: Poggesi
authors: Jan
authors: J
authors: Snoeys
authors: Achiel
authors: A
authors: Van Peer
mesh_terms: D004347:Drug Interactions; D006801:Humans; D008954:Models, Biological; D010599:Pharmacokinetics; D010601:Pharmacology, Clinical / Q000379:methods / Q000639:trends; D010827:Physiology / Q000379:methods / Q000639:trends