中药、天然药物主要研究结果的总结及评价撰写格式和要求技术指导原则.pdfVIP

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中药、天然药物主要研究结果的总结及评价撰写格式和要求技术指导原则.pdf

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中药、天然药物主要研究结果的总结及评价撰写格式和要求技术指导原则

中药、天然药物主要研究结果的总结及评价撰写格式和要求技术指导原则（第二稿草稿）二 OO 五年三月目录一、概述··································································································································· 1 二、撰写格式和要求····················································································· 1 （一）中药、天然药物新药申请 ················································································ 1 1.申请临床研究·····················································································································1 1.1 品种概况·························································································································· 1 1.2 主要研究结果的总结···································································································· 2 1.2.1 药学····································································································· 2 1.2.2 药理毒理································································································ 3 1.2.3 临床···································································································· 3 1.3 综合分析与评价············································································································ 4 2. 申请生产··························································································································· 6 2.1 品种概况··