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天然药物临床研究资料综述撰写技术指导原则.DOC
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
1
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···························································································· 3
(二) 申请生产·················································································································· 3
1. 主要内容··················································································································· 4
1.1 Ⅰ期临床试验概要··························································································· 4
1.1.1 人体耐受性试验概要··············································································· 4
1.1.2 临床药理学试验概要··············································································· 4
1.2 Ⅱ期临床试验概要····························································································· 5
1.3 Ⅲ期临床试验概要····························································································· 5
2. 分析与评价········································
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