Regulatory Experience with Continuous Manufacturing and Real Time Release Testing for Dissolution in New Drug Applications.

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作者： Maziar,Kakhi ^[1] ; Jing,Li ^[2] ; Angelica,Dorantes ^[2]

作者单位： Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: maziar.kakhi@fda.hhs.gov. ^[1] Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. ^[2]

关键词 Biopharmaceutics Continuous manufacturing Design of experiments (DoE)FDA Modeling Real time release testing (RTRT) for dissolution

主题词美国(United States);溶解度(Solubility);生物药学(Biopharmaceutics);片剂(Tablets);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1016/j.xphs.2023.08.004

PMID 37572781

发布时间 2023-09-20

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