美国FDA 指导原则 申请表的临床和统计部分的格式和内容 英文原版.pdfVIP

Center for Drug Evaluation and Research Food and Drug Administration Department of Health and Human Services GUIDELINE FOR THE FORMAT AND CONTENT OF THE CLINICAL AND STATISTICAL SECTIONS OF AN APPLICATION July 1988 For further information regarding the clinical aspects of the guideline please contact: Food and Drug Administration Center for Drug Evaluation and Research Office of Drug Evaluation I (HFD-1OO) 5600 Fishers Lane Rockville, Maryland 20857 (301 ) 443-4330 For further information regarding the statistical aspects of the guideline please contact: Food and Drug Administration Center for Drug Evaluation and Research Office of Epidemiology and Biostatistics Division of Biometrics Statistical Evaluation and Research Branch (HFD-713) 5600 Fishers Lane Rockville, Maryland 20857 (301 ) 443-4594 (ii) CONTENT OF THE GUIDELINE I. Introduction 1 II. Overall Format and Content of the Clinical and Statistical Sections 10 [21 CFR 314.50(d)(5) and (6)] A. List of Investigators and List of IND’s and NDA’s 10 B. Background/Overview of Clinical Investigations 10 c. Clinical Pharmacology [21 CFR 314.50(d)(5)(i)] 12 1. Types of studies