At the end of March,() were planned.(General, Classification, Reclassification). Based on risks, the
15. FDA Powder Blends and Finished Dosage Units—Stratified In-. What were the Agency’s major conce
我们准备申报一品种上了中国药典,有关物质采用的TLC法,我们准备改成HPLC法,参照欧洲药典(EP)的有关物质的方法做的。但EP上有A、B、C、D、E杂质。我们参照EP只做了A、B、C系统(有关物质)
FDA 的Guidance for Industry ANDAs:&A中有关包装:Oral dosage forms(a) Tablets/Capsules (e.g., immediate rele
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“ANDA Submissions—Refuse-to-Receive Standards.”.. A refuse-to-, usually because of omissions., 2012
总局首次公告适用ICH指导原则三步走:中国制药加速接轨国际标准 自上而下,由顶层设计出发,引领中国行业与国际接轨 指导原则分三步实施,逐步提高我国药企药品全生命周期管理水平 企业需培
USP不同版本中收载的质量标准,部分内容发生变动,那么USP有具体公告内容吗,这块在哪里查,哪位可以告知,谢谢!比如下面这个The limit for Olanzapine related compo
2004年7月PhRMA提交给商务部的目录如下:..........................................5II.........7A. Role of Government
LTD3/F, Building A, No 388Yindu Road, Xuhui DistrictShanghai 200231, China Dear Mr. Chiu:, China
Short Title. This Act shall be known as the "(TAMA) of 1997".. Declaration of Policy...,. Section