Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables.

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作者： Daniela,Amaral Silva ^[1] ; Maxime,Le Merdy ^[1] ; Khondoker Dedarul,Alam ^[2] ; Yan,Wang ^[2] ; Quanying,Bao ^[3] ; Nilesh,Malavia ^[3] ; Diane,Burgess ^[3] ; Viera,Lukacova ^[1]

作者单位： Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, CA 93534, USA. ^[1] Division of Quantitative Methods and Modeling, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA. ^[2] Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA. ^[3]

关键词 PBBK PBBM complex generics long-acting injectable suspensions medroxyprogesterone acetate

DOI 10.3390/pharmaceutics16040552

PMID 38675213

发布时间 2024-04-29

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