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Advancing Predictions of Tissue and Intracellular Drug Concentrations Using In Vitro, Imaging and Physiologically Based Pharmacokinetic Modeling Approaches
Eli Lilly & Co, Lilly Corp Ctr, Invest Drug Disposit, Indianapolis, IN 46285 USA.
Merck & Co Inc, Depat Pharmacokinet Pharmacodynam & Drug Metab, Kenilworth, NJ USA.
F Hoffmann La Roche Ltd, Roche Innovat Ctr Basel, Pharmaceut Sci Pharmaceut Res & Early Dev, Basel, Switzerland.
Univ N Carolina, UNC Eshelman Sch Pharm, Div Pharmacotherapy & Expt Therapeut, Chapel Hill, NC 27515 USA.
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2018 (English)In: Clinical Pharmacology and Therapeutics, ISSN 0009-9236, E-ISSN 1532-6535, Vol. 104, no 5, p. 865-889Article, review/survey (Refereed) Published
Abstract [en]

This white paper examines recent progress, applications, and challenges in predicting unbound and total tissue and intra/subcellular drug concentrations using in vitro and preclinical models, imaging techniques, and physiologically based pharmacokinetic (PBPK) modeling. Published examples, regulatory submissions, and case studies illustrate the application of different types of data in drug development to support modeling and decision making for compounds with transporter-mediated disposition, and likely disconnects between tissue and systemic drug exposure. The goals of this article are to illustrate current best practices and outline practical strategies for selecting appropriate in vitro and in vivo experimental methods to estimate or predict tissue and plasma concentrations, and to use these data in the application of PBPK modeling for human pharmacokinetic (PK), efficacy, and safety assessment in drug development.

Place, publisher, year, edition, pages
John Wiley & Sons, 2018. Vol. 104, no 5, p. 865-889
National Category
Pharmacology and Toxicology Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-369941DOI: 10.1002/cpt.1183ISI: 000448068500014PubMedID: 30059145OAI: oai:DiVA.org:uu-369941DiVA, id: diva2:1272246
Funder
NIH (National Institute of Health), R01 GM041935, R35 GM122576, 1R01GM104178, 1R01GM114369, DA P01DA032507Available from: 2018-12-18 Created: 2018-12-18 Last updated: 2018-12-18Bibliographically approved

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Matsson, Pär

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