I. Background Information 背景研究
A. Phases of a Clinical Investigation 临床研究的阶段
1. Phase 1. 1期
2. Phase 2. 2期
3. Phase 3. 3期
B. General Principles of the IND Submission IND申报的通用原则
C. Reference to IND or Marketing Information Previously Submitted
IND参考或这之前已上市信息
D. FDA Administrative Actions FDA行政信息
1. Effective date of FDA acceptance of an IND application.
FDA接收IND申请的有效日期
2. Clinical holds and requests for modifications
临床持有人以及修订变更的申请
3. FDA termination of an IND
FDA对终止某项IND
4. Inactive status.
非激活状态
II. Initial IND Application: Content and Format
A. Form FDA 1571 FDA 1571表格
B. Table of Contents 目录
C. Introductory Statement and General Investigational Plan
介绍性说明和一般调研性计划
D. Investigator’s Brochure 研究者手册
1. Investigator-sponsored IND. 申报方赞助开展的IND
2. University-sponsored IND. 研究性大学开展的IND
E. Clinical Protocol(s) 临床方案
1. General principles. 一般原则
2. Protocol content and format. 方案内容和格式
F. Chemistry, Manufacturing and Control (CMC) Information CMC信息
1. General principles.一般原则
2. CMC content and format. CMC内容和格式
3. cGMP compliance. cGMP合规性
G. Labeling 标签
1. IND submission requirements. IND递交要求
2. Investigational drug labeling requirements. 研究性药物标签信息
H. Pharmacology and Toxicology Information 药理学和毒理学信息
1. General principles. 一般原则
2. Content and format. 内容和格式
I. Previous Human Experience with the Investigational Drug
研究性药物之前的人用经验
J. Additional Information 额外信息
1. Drug dependence and abuse potential. 药物依赖性和滥用潜能
2. Radioactive drugs. 放射性药物
3. Pediatric studies. 儿童研究
4. Other information. 其他信息
K. FDA-Requested Relevant Information FDA要求的其他相关信息
