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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.doc
(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·········································································································?11.?主要内容···················································································································?11.1?命名依据··············································································································?11.2?立题目的和依据································································································?11.3?临床研究计划·····································································································?21.3.1?人体耐受性试验方案················································································?21.3.2?期临床试验方案·························································································?22.?分析与评价····························································································?3(二)?申请生产··················································································································?31.?主要内容···················································································································?41.1?期临床试验概要···························································································?41.1.1?人体耐受性试验概要···············································································?41.1.2?临床药理学试验概要···············································································?41.2?Ⅱ期临床试验概要·····························································································?51.3?期临床试验概要·····························································································?52.?分析与评价····························
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