Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

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作者： Jenn W,Sellers ^[1] ; Camelia M,Mihaescu ^[2] ; Kassa,Ayalew ^[3] ; Phillip D,Kronstein ^[3] ; Bei,Yu ^[3] ; Yang-Min,Ning ^[3] ; Miguel,Rodriguez ^[2] ; LaKisha,Williams ^[3] ; Ni A,Khin ^[3]

作者单位： Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA. jenn.sellers@fda.hhs.gov. ^[1] Inspections Office, Quality and Safety of Medicines Department, European Medicines Agency (EMA), Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands. ^[2] Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA. ^[3]

关键词 Bioresearch monitoring Clinical investigator Good clinical practice inspection Inspection finding Sponsor

主题词文献工作(Documentation);坚持准则(Guideline Adherence);人类(Humans);营销(Marketing);研究人员(Research Personnel);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1007/s43441-022-00417-w

PMID 35610469

发布时间 2022-08-26

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Therapeutic innovation & regulatory science

2022年56卷5期

753-764页

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Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

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Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

Therapeutic innovation & regulatory science

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Therapeutic innovation & regulatory science

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