ICH M7（step4)：诱变性杂质评估和控制（翻译：zhuyujiao1972）
A SSESSMENT AND C ONTROL OF DNA R EACTIVE (M UTAGENIC) I MPURITIES IN P HARMACEUTICALS TO L IMIT P OTENTIAL C ARCINOGENIC R ISK 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
M7
Current Step 4 version
dated 23 June 2014
This 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.
M7
Document History 文件历史
Current Step 4 version 现行版本第4阶段
reactive substance
Legal 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 ICH's 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 impression that the adaptio
n, 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, permission for reproduction must be obtained from this copyright holder.
A SSESSMENT AND C ONTROL OF DNA R EACTIVE (M UTAGENIC)
I MPURITIES IN P HARMACEUTICALS TO L IMIT P OTENTIAL
C ARCINOGENIC R ISK
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
ICH Harmonised Tripartite Guideline
ICH三方协调指南
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 5 June 2014, this Guideline is recommended for adoption to the three regulatory parties to ICH

版权声明：本站内容均来自互联网，仅供演示用，请勿用于商业和其他非法用途。如果侵犯了您的权益请与我们联系QQ:729038198，我们将在24小时内删除。