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·········································································································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················································································21.3.2Ⅱ期临床试验方案·························································································22.分析与评价····························································································3(二)申请生产··················································································································31.主要内容···················································································································41.1Ⅰ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···············································································41.2Ⅱ期临床试验概要··············································...
