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

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作者： Claire,Mackie ^[1] ; Sumit,Arora ^[1] ; Paul,Seo ^[2] ; Rebecca,Moody ^[3] ; Bhagwant,Rege ^[3] ; Xavier,Pepin ^[4] ; Tycho,Heimbach ^[5] ; Christer,Tannergren ^[6] ; Amitava,Mitra ^[7] ; Sandra,Suarez-Sharp ^[4] ; Luiza Novaes,Borges ^[8] ; Shinichi,Kijima ^[9] ; Evangelos,Kotzagiorgis ^[10] ; Maria,Malamatari ^[11] ; Shereeni,Veerasingham ^[12] ; James E,Polli ^[13] ; Gregory,Rullo ^[14]

作者单位： Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium. ^[1] 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. ^[2] Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States. ^[3] Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States. ^[4] Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., 123 East Scott Ave., Rahway, New Jersey 07065, United States. ^[5] Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 83, Sweden. ^[6] Clinical Pharmacology, Kura Oncology, Inc., Boston, Massachusetts 02210, United States. ^[7] ANVISA, SIA Trecho 5 - Guará, Brasília, Distrito Federal 71205-050, Brazil. ^[8] Office of New Drug V, Pharmaceutical and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan. ^[9] European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands. ^[10] Medicines & Healthcare products Regulatory Agency, 10 South Colonnade, London E14 4PU, United Kingdom. ^[11] Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott Street, Ottawa, Ontario K1A 0K9, Canada. ^[12] School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States. ^[13] Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States. ^[14]

关键词 MIDD (model informed drug development)PBBM (physiologically based biopharmaceutics model(s)(ing)PBPK (physiologically based pharmacokinetics)biopredictive dissolution clinically relevant dissolution specifications (CRDS)drug product performance drug product quality patient-centric drug product quality standards safe space virtual bioequivalence (VBE)

主题词人类(Humans);生物药学(Biopharmaceutics);制药工业(Drug Industry);模型, 生物学(Models, Biological);治疗等效(Therapeutic Equivalency);药用制剂(Pharmaceutical Preparations);美国(United States)

DOI 10.1021/acs.molpharmaceut.4c00202

PMID 38600804

发布时间 2024-05-21

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