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- [31] Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines AgencyTHERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2023, 57 (01) : 79 - 85Ayalew, Kassa论文数: 0 引用数: 0 h-index: 0机构: US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA US FDA, 10903 New Hampshire Ave,White Oak Bldg 51, Silver Spring, MD 20993 USA US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USANing, Yang-Min论文数: 0 引用数: 0 h-index: 0机构: US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USAForinger, Michelle J.论文数: 0 引用数: 0 h-index: 0机构: US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USALeibenhaut, Susan论文数: 0 引用数: 0 h-index: 0机构: US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USASellers, Jenn W.论文数: 0 引用数: 0 h-index: 0机构: US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USAYu, Bei论文数: 0 引用数: 0 h-index: 0机构: US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USAKronstein, Phillip D.论文数: 0 引用数: 0 h-index: 0机构: US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USAHiggerson, Agata论文数: 0 引用数: 0 h-index: 0机构: European Med Agcy EMA, Inspect Off, Qual & Safety Med Dept, Domenico Scarlattilaan 6, NL-1083 HS Amsterdam, Netherlands US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USAMihaescu, Camelia论文数: 0 引用数: 0 h-index: 0机构: European Med Agcy EMA, Inspect Off, Qual & Safety Med Dept, Domenico Scarlattilaan 6, NL-1083 HS Amsterdam, Netherlands US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USARodriguez, Miguel论文数: 0 引用数: 0 h-index: 0机构: European Med Agcy EMA, Inspect Off, Qual & Safety Med Dept, Domenico Scarlattilaan 6, NL-1083 HS Amsterdam, Netherlands US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USAWilliams, LaKisha论文数: 0 引用数: 0 h-index: 0机构: US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USAKhin, Ni A.论文数: 0 引用数: 0 h-index: 0机构: US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA US FDA, Div Clin Compliance Evaluat, Off Sci Invest, Off Compliance,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
- [32] Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines AgencyTherapeutic Innovation & Regulatory Science, 2023, 57 : 79 - 85Kassa Ayalew论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchYang-Min Ning论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchMichelle J. Foringer论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchSusan Leibenhaut论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchJenn W. Sellers论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchBei Yu论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchPhillip D. Kronstein论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchAgata Higgerson论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchCamelia Mihaescu论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchMiguel Rodriguez论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchLaKisha Williams论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and ResearchNi A. Khin论文数: 0 引用数: 0 h-index: 0机构: United States (US) Food and Drug Administration (FDA),Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research