中药、天然药物临床研究资料综述撰写格式和要求技术指导原则

中药、天然药物临床研究资料综述撰写格式和要求技术指导原则

中药、天然药物临床研究资料综述撰写

格式和要求技术指导原则

（第二稿草稿）

二OO五年三月

中药、天然药物临床研究资料综述撰写格式和要求技术指导原则

目 录

一. 概述································································································································ 1

二. 撰写格式和要求···································································· 1

(一) 申请临床研究········································································································· 1

1. 主要内容··················································································································· 1

1.1 命名依据 ·············································································································· 1

1.2 立题目的和依据 ································································································ 1

1.3 临床研究计划 ····································································································· 2

1.3.1 人体耐受性试验方案 ················································································ 2

1.3.2 Ⅱ期临床试验方案························································································· 2

2. 分析与评价················