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Pharmaceutical Industry Practices on Genotoxic Impurities (2015出版)
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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 |
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