17、说明书撰写
药品说明书中[适应症]、[用法用量]、[不良反应]等各项内容撰写均基于临床试验结果。以说明书中的适应症为例，在ABSSSI适应症中需列出由何种病原菌所致者，可列入适应症的细菌种类必须是ABSSSI的目标病原菌，其所致感染临床疗效为治愈和微生物学疗效为细菌清除或假定清除。病例数需达该目标适应症观察例数的10％（至少10例）。有关说明书撰写详见《抗菌药物说明书撰写技术指导原则》中相关内容。 三、主要参考文献
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