ICHM7step4基因毒性杂质评估和控制中英
73页1、ASSESSMENT ANDCONTROL OFDNA REACTIVE(MUTAGENIC) IMPURITIES INPHARMACEUTICALS TOLIMITPOTENTIALCARCINOGENICRISK为限制潜在致癌风险而对药物中DNA活性(诱变性)杂质进行的评估和控制M7CurrentStep 4versiondated 23 June 2014This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.M7Docume
2、nt History文件历史Code文件代码History历史Date日期M7Approval by the Steering Committee under Step 2 and release for public consultation.第2阶段由筹委会批准,公开征求意见6 February 2013M7Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.第4阶段由筹委会批准,推荐ICH三方药监局采用5 June 2014Current Step 4 version现行版本第4阶段M7Corrigendum to fix typographical errors and replace word “degradants” with “degradation products” throughout the document.修正输入错误,将全文中“degradants”替换成“degradation p
3、roducts”.23 June 2014Legal Notice:This document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICHs copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impress
4、ion that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided.The document is provided as is without warranty of any kind. In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document.The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, perm
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