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Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.

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Title: Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.
Authors: Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium., Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium., Seo P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States., Moody R; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States., Rege B; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States., Pepin X; Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States., Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., 123 East Scott Ave., Rahway, New Jersey 07065, United States., Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 83, Sweden., Mitra A; Clinical Pharmacology, Kura Oncology, Inc., Boston, Massachusetts 02210, United States., Suarez-Sharp S; Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States., Borges LN; ANVISA, SIA Trecho 5 - Guará, Brasília, Distrito Federal 71205-050, Brazil., Kijima S; Office of New Drug V, Pharmaceutical and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan., Kotzagiorgis E; European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands., Malamatari M; Medicines & Healthcare products Regulatory Agency, 10 South Colonnade, London E14 4PU, United Kingdom., Veerasingham S; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott Street, Ottawa, Ontario K1A 0K9, Canada., Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States., Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States.
Source: Molecular pharmaceutics [Mol Pharm] 2024 May 06; Vol. 21 (5), pp. 2065-2080. Date of Electronic Publication: 2024 Apr 10.
Publication Type: Journal Article; Research Support, Non-U.S. Gov't; 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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  Data: Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.
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  Data: <searchLink fieldCode="AU" term="%22Mackie+C%22">Mackie C</searchLink>; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium.<br /><searchLink fieldCode="AU" term="%22Arora+S%22">Arora S</searchLink>; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium.<br /><searchLink fieldCode="AU" term="%22Seo+P%22">Seo P</searchLink>; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States.<br /><searchLink fieldCode="AU" term="%22Moody+R%22">Moody R</searchLink>; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States.<br /><searchLink fieldCode="AU" term="%22Rege+B%22">Rege B</searchLink>; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States.<br /><searchLink fieldCode="AU" term="%22Pepin+X%22">Pepin X</searchLink>; Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States.<br /><searchLink fieldCode="AU" term="%22Heimbach+T%22">Heimbach T</searchLink>; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., 123 East Scott Ave., Rahway, New Jersey 07065, United States.<br /><searchLink fieldCode="AU" term="%22Tannergren+C%22">Tannergren C</searchLink>; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 83, Sweden.<br /><searchLink fieldCode="AU" term="%22Mitra+A%22">Mitra A</searchLink>; Clinical Pharmacology, Kura Oncology, Inc., Boston, Massachusetts 02210, United States.<br /><searchLink fieldCode="AU" term="%22Suarez-Sharp+S%22">Suarez-Sharp S</searchLink>; Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States.<br /><searchLink fieldCode="AU" term="%22Borges+LN%22">Borges LN</searchLink>; ANVISA, SIA Trecho 5 - Guará, Brasília, Distrito Federal 71205-050, Brazil.<br /><searchLink fieldCode="AU" term="%22Kijima+S%22">Kijima S</searchLink>; Office of New Drug V, Pharmaceutical and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan.<br /><searchLink fieldCode="AU" term="%22Kotzagiorgis+E%22">Kotzagiorgis E</searchLink>; European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Malamatari+M%22">Malamatari M</searchLink>; Medicines & Healthcare products Regulatory Agency, 10 South Colonnade, London E14 4PU, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Veerasingham+S%22">Veerasingham S</searchLink>; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott Street, Ottawa, Ontario K1A 0K9, Canada.<br /><searchLink fieldCode="AU" term="%22Polli+JE%22">Polli JE</searchLink>; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States.<br /><searchLink fieldCode="AU" term="%22Rullo+G%22">Rullo G</searchLink>; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States.
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  Data: <searchLink fieldCode="JN" term="%22101197791%22">Molecular pharmaceutics</searchLink> [Mol Pharm] 2024 May 06; Vol. 21 (5), pp. 2065-2080. <i>Date of Electronic Publication: </i>2024 Apr 10.
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