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Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications.

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第一作者： Sandra,Suarez-Sharp

第一单位： Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. Sandra.Suarez@fda.hhs.gov.

作者： Sandra,Suarez-Sharp ^[1] ; Poonam R,Delvadia ^[2] ; Angelica,Dorantes ^[2] ; John,Duan ^[2] ; Anna,Externbrink ^[3] ; Zongming,Gao ^[3] ; Tapash,Ghosh ^[2] ; Sarah Pope,Miksinski ^[4] ; Paul,Seo ^[2]

作者单位： Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. Sandra.Suarez@fda.hhs.gov. ^[1] Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. ^[2] Division of Pharmaceutical Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, St. Louis, Missouri, USA. ^[3] Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. ^[4]

关键词 biowaivers immediate release oral dosage forms multi-unit dissolution testing strength-dependent dissolution acceptance criteria strength-dependent dissolution profiles