24小时热门版块排行榜

返回列表

【奖励】本帖被评价155次，作者1949stone增加金币 121.8 个

当前只显示满足指定条件的回帖，点击这里查看本话题的所有回帖

1949stone

荣誉版主 (知名作家)

应助: 95 (初中生)
贵宾: 2.38
金币: 2622.9
帖子: 9829
在线: 2692.8小时
虫号: 765987

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

如果adobe阅读器打不开,请试一下其他pdf阅读器.

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

回复此楼

» 本帖附件资源列表

欢迎监督和反馈：小木虫仅提供交流平台，不对该内容负责。
本内容由用户自主发布，如果其内容涉及到知识产权问题，其责任在于用户本人，如对版权有异议，请联系邮箱：xiaomuchong@tal.com
附件 1 : Pharmaceutical_Industry_Practices_on_Genotoxic_Impurities_(1).pdf

2015-04-06 03:02:10, 5.65 M