International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 12 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on analytical(国际协调人用药品注册技术要求会议 (ICH) 指南 Q4B 附件 12 用于评估和推荐用于 ICH 地区分析的药典文本的说明)