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Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.

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Title: Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.
Authors: Pepin X; Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States., Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Borges L; ANVISA, SIA Trecho 5́, Guara, Brasília, Federal District 71205-050, Brazil., Cano-Vega M; Drug Product Technologies, Amgen Inc., Thousand Oaks, California 91320-1799, United States., Carducci T; Analytical Commercialization Technology, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, New Jersey 07065, United States., Chatterjee P; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Chen G; Takeda Development Center Americas Inc., 300 Shire Way, Lexington, Massachusetts 02421, United States., Cristofoletti R; College of Pharmacy, University of Florida, 6550 Sanger Rd., Orlando, Florida 32827, United States., Dallmann A; Bayer HealthCare SAS, 59000 Lille, France, on behalf of Bayer AG, Pharmacometrics/Modeling and Simulation, Systems Pharmacology & Medicine, PBPK, Leverkusen, Germany., Delvadia P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Dressman J; Fraunhofer Institute of Translational Medicine and Pharmacology, Frankfurt am Main 60596, Germany., Fotaki N; University of Bath, Claverton Down, Bath BA2 7AY, United Kingdom., Gray E; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States., Holte Ø; Norwegian Medical Products Agency, Oslo 0213, Norway., Kijima S; Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan., Kotzagiorgis E; European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands., Lennernäs H; Translational Drug Discovery and Development, Department of Pharmaceutical Bioscience, Uppsala University, Uppsala 751 05, Sweden., Lindahl A; Swedish Medical Products Agency, Uppsala 752 37, Sweden., Loebenberg R; Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmontonton T6G 2E1, Canada., Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Malamatari M; Medicines & Healthcare Products Regulatory Agency, 10 S Colonnade, London SW1W 9SZ, United Kingdom., McAllister M; Global Biopharmaceutics, Drug Product Design, Pfizer, Sandwich CT13 9NJ, United Kingdom., Mitra A; Clinical Pharmacology, Kura Oncology Inc., Boston, Massachusetts 02210, United States., Moody R; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Mudie D; Global Research and Development, Small Molecules, Lonza, 63045 NE Corporate Pl., Bend, Oregon 97701, United States., Musuamba Tshinanu F; Belgian Federal Agency for Medicines and Health Products, Galileelaan 5/03, Brussel 1210, Belgium., Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States., Rege B; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Ren X; PK Sciences/Translational Medicine, BioMedical Research, Novartis, One Health Plaza, East Hanover, New Jersey 07936, United States., Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States., Scherholz M; Pharmaceutical Development, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, New Jersey 08543, United States., Song I; Takeda Development Center Americas Inc., 300 Shire Way, Lexington, Massachusetts 02421, United States., Stillhart C; Pharmaceutical R&D, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland., Suarez-Sharp S; Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States., Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 50, Sweden., Tsakalozou E; 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 K1A 0K9, Canada., Wagner C; Global Drug Product Development, Global CMC Development, the Healthcare Business of Merck KGaA, Darmstadt D-64293, Germany., Seo P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.
Source: Molecular pharmaceutics [Mol Pharm] 2024 Aug 05; Vol. 21 (8), pp. 3697-3731. Date of Electronic Publication: 2024 Jun 30.
Publication Type: Journal Article; Review; 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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