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

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