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A comprehensive approach to qualify and validate the essential parameters of an in vitro release test (IVRT) method for acyclovir cream, 5.

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第一作者： Katrin I,Tiffner

第一单位： Joanneum Research Forschungsgesellschaft mbH, Health - Institute for Biomedicine and Health Sciences, Neue Stiftingtalstr. 2, 8010 Graz, Austria.

作者： Katrin I,Tiffner ^[1] ; Isadore,Kanfer ^[2] ; Thomas,Augustin ^[1] ; Reingard,Raml ^[1] ; Sam G,Raney ^[3] ; Frank,Sinner ^[1]

作者单位： Joanneum Research Forschungsgesellschaft mbH, Health - Institute for Biomedicine and Health Sciences, Neue Stiftingtalstr. 2, 8010 Graz, Austria. ^[1] Rhodes University, Faculty of Pharmacy, Artillery Road, Grahamstown 6140, South Africa; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada. Electronic address: izzy.kanfer@gmail.com. ^[2] Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, U.S. FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. ^[3]

关键词 Acyclovir cream Apparatus qualification In vitro release testing Method validation Vertical diffusion cell

医学主题词阿昔洛韦(Acyclovir);抗病毒药(Antiviral Agents);化学, 药物(Chemistry, Pharmaceutical);色谱法, 高压液相(Chromatography, High Pressure Liquid);软膏(Ointments);结果可重复性(Reproducibility of Results)

DOI 10.1016/j.ijpharm.2017.09.049

PMID 28935255

发布时间 2018-08-29

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