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1949stone

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[资源] Pharmaceutical Industry Practices on Genotoxic Impurities (2015出版)

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Pharmaceutical Industry Practices on Genotoxic Impurities (2015出版)


Chapter 1  Overview of Regulatory Guidelines on Impurities and Genotoxic Impurities
Chapter 2  Structural Alerts for Genotoxicity and Carcinogenicity
Chapter 3  Acceptable Exposure Calculations for Impurities and Selected
Chapter 4  Genotoxic Impurities from Toxicology Perspectives Including
Cancer Risk Assessment, In Silico, In Vitro/In Vivo Testings, and Regulatory Aspects
Chapter 5  In Silico/Computational Assessment for the Evaluation of Genotoxic Impurities
Chapter 6  Preclinical Assessment of Genotoxic Impurities An Overview of Current Regulatory Guidance, Available Assays, and Data Interpretation
Chapter 7  Purification of Lead Compounds for Early Toxicology Profiling such as Ames and Short-Term Non-GLP (Good Laboratory Practice) Toxicology Tests
Chapter 8  Analysis of Genotoxic Impurities in Pharmaceuticals by Gas Chromatography–Mass Spectrometry
Chapter 9  Control of Chloroethane in Raw Materials and Drug Substances Using Headspace/Gas Chromatography Analysis
Chapter 10  Quantification of Genotoxic Impurities in Active Pharmaceutical Ingredient
Chapter 11  Analytical Testing and Control for Genotoxic Impurities in Drug Substances
Chapter 12  Approaches to Assess, Analyze, and Control Genotoxic Impurities in Drug Substance Development
Chapter 13  Control and Analysis of Genotoxic Impurities in Drug Substance Development
Chapter 14  Salt Formation of Pharmaceutical Compounds and Associated Genotoxic Risk
Chapter 15  Identification and Control of Genotoxic Degradation Products  
Chapter 16  Identification and Qualification of Genotoxic Impurities as Leachables in Drug Products
Chapter 17  Pharmaceutical Industry Survey on Genotoxic Impurities and Related Topics
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楼主你真是太好了,多谢!
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1949stone

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引用回帖:
3楼: Originally posted by allylation at 2015-04-06 08:36:41
打不开

我试过了可以下载也可以打开.
这个文件你要是用adobe打开有时会有问题,换了pdf软件就可以了
5楼2015-04-06 09:55:16
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简单回复
2015-04-06 07:48   回复  
五星好评  顶一下,感谢分享!
qiute6216楼
2015-04-06 14:05   回复  
五星好评  顶一下,感谢分享!
lazio1117楼
2015-04-06 15:22   回复  
五星好评  顶一下,感谢分享!
plumty8楼
2015-04-06 15:27   回复  
五星好评  顶一下,感谢分享!
ashlink9楼
2015-04-06 15:34   回复  
五星好评  顶一下,感谢分享!
苦头陀10楼
2015-04-06 15:41   回复  
五星好评  顶一下,感谢分享!
sjshvdc11楼
2015-04-06 16:43   回复  
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2015-04-06 16:58   回复  
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wang36913楼
2015-04-06 17:11   回复  
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2015-04-06 17:23   回复  
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