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Title: Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report.
Authors: Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 43183, Sweden., Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Babiskin A; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States., Borges L; Brazilian Health Regulatory Agency (ANVISA), SIA Trecho 5 - Guará, Brasília, Distrito Federal 71205-050, Brazil., Chatterjee P; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States., Cheng YH; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States., Dallmann A; Bayer HealthCare SAS, Lille, France, on behalf of Pharmacometrics/Modeling & Simulation, Research & Development, Pharmaceuticals, Bayer AG, Leverkusen 51368, Germany., Govada A; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States., Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States., Hingle M; Technical Research and Development, Novartis Pharma AG, Basel 4056, Switzerland., Kollipara S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Bachupally, Medchal Malkajgiri District, Hyderabad, Telangana 500 090, India., Kotzagiorgis E; European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands., Lindahl A; Swedish Medical Products Agency, Uppsala 752 37, Sweden., Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Malamatari M; Medicines & Healthcare Products Regulatory Agency, London E14 4PU, United Kingdom., Mitra A; Clinical Pharmacology, Kura Oncology, Inc., Boston, Massachusetts 02210, United States., Moody R; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States., Pepin X; Regulatory Strategies Center of Excellence, Simulations Plus, Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States., Polli J; Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland 21201, United States., Raines K; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States., Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States., Sanghavi M; Certara Predictive Technologies, Level 2-Acero, Simcyp, Ltd., 1 Concourse Way, Sheffield S1 2BJ, United Kingdom., Savkur R; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States., Singh R; Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania 19380, United States., Sjögren E; Pharmetheus, Uppsala 752 37, Sweden.; Department of Pharmaceutical Bioscience, Translational Drug Discovery and Development, Uppsala University, SE-75124 Uppsala, Sweden., Suarez-Sharp S; Regulatory Strategies Center of Excellence, Simulations Plus, Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States., Thomas S; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States., Veerasingham S; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott St., Ottawa, Ontario K1A 0K9, Canada., Wei K; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States., Wu F; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States., Xu Y; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States., Yoon M; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Centre for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland 20993-0002, United States., Rege B; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.
Source: Molecular pharmaceutics [Mol Pharm] 2025 Jan 06; Vol. 22 (1), pp. 5-27. Date of Electronic Publication: 2024 Dec 16.
Publication Type: Journal Article; Research Support, U.S. Gov't, P.H.S.
Journal Info: Publisher: American Chemical Society Country of Publication: United States NLM ID: 101197791 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1543-8392 (Electronic) Linking ISSN: 15438384 NLM ISO Abbreviation: Mol Pharm Subsets: MEDLINE
Database: MEDLINE Ultimate
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Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States.<br /><searchLink fieldCode="AU" term="%22Dallmann+A%22">Dallmann A</searchLink>; Bayer HealthCare SAS, Lille, France, on behalf of Pharmacometrics/Modeling & Simulation, Research & Development, Pharmaceuticals, Bayer AG, Leverkusen 51368, Germany.<br /><searchLink fieldCode="AU" term="%22Govada+A%22">Govada A</searchLink>; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.<br /><searchLink fieldCode="AU" term="%22Heimbach+T%22">Heimbach T</searchLink>; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States.<br /><searchLink fieldCode="AU" term="%22Hingle+M%22">Hingle M</searchLink>; Technical Research and Development, Novartis Pharma AG, Basel 4056, Switzerland.<br /><searchLink fieldCode="AU" term="%22Kollipara+S%22">Kollipara S</searchLink>; 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Certara Predictive Technologies, Level 2-Acero, Simcyp, Ltd., 1 Concourse Way, Sheffield S1 2BJ, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Savkur+R%22">Savkur R</searchLink>; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.<br /><searchLink fieldCode="AU" term="%22Singh+R%22">Singh R</searchLink>; Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania 19380, United States.<br /><searchLink fieldCode="AU" term="%22Sjögren+E%22">Sjögren E</searchLink>; Pharmetheus, Uppsala 752 37, Sweden.; Department of Pharmaceutical Bioscience, Translational Drug Discovery and Development, Uppsala University, SE-75124 Uppsala, Sweden.<br /><searchLink fieldCode="AU" term="%22Suarez-Sharp+S%22">Suarez-Sharp S</searchLink>; Regulatory Strategies Center of Excellence, Simulations Plus, Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States.<br /><searchLink fieldCode="AU" term="%22Thomas+S%22">Thomas S</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States.<br /><searchLink fieldCode="AU" term="%22Veerasingham+S%22">Veerasingham S</searchLink>; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott St., Ottawa, Ontario K1A 0K9, Canada.<br /><searchLink fieldCode="AU" term="%22Wei+K%22">Wei K</searchLink>; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.<br /><searchLink fieldCode="AU" term="%22Wu+F%22">Wu F</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States.<br /><searchLink fieldCode="AU" term="%22Xu+Y%22">Xu Y</searchLink>; 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