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
最吝啬的人成语
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
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郝斌中学A SSESSMENT AND C ONTROL OF DNA R EACTIVE (M UTAGENIC)豆角做法
I MPURITIES IN P HARMACEUTICALS TO L IMIT P OTENTIAL
C ARCINOGENIC R ISK
神秘岛门票
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 Harmonid Tripartite Guideline
ICH三方协调指南
教你下围棋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
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