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药学资料撰写的格式内容技术指导.

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  • 药学资料撰写的格式内容技术指导.的内容简介:

    一、概述···················································································································· 1二、撰写格式和要求······································································ 1(一)中药、天然药物新药申请········································································· 11、申请临床研究··························································································11.1主要研究结果综述····················································································· 11.2分析与评价······················································································ 32、申请生产············································································································· 32.1主要研究结果综述··················································································· 32.2分析与评价································································································ 4(二)已有国家标准的中药、天然药物的申请········································· 51、主要研究结果综述··············································································· 52、分析与评价································································································ 6三、参考文献··································································································· 6四、著者··················································································································· 6

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