| Description |
1 online resource |
| Series |
Chromatographic Science Series |
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Chromatographic science.
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| Contents |
Front Cover; Contents; Preface; Editor; List of Contributors; 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 Compounds from the Carcinogenic Potency Database; 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 |
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Chapter 6: Preclinical Assessment of Genotoxic Impurities : An Overview of Current Regulatory Guidance, Available Assays, and Data InterpretationChapter 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 |
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Chapter 10: Quantification of Genotoxic Impurities in Active Pharmaceutical IngredientsChapter 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 Risks; Chapter 15: Identification and Control of Genotoxic Degradation Products |
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Chapter 16: Identification and Qualification of Genotoxic Impurities as Leachables in Drug ProductsChapter 17: Pharmaceutical Industry Survey on Genotoxic Impurities and Related Topics; Back Cover |
| Summary |
A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text:Explores the safety, quality, and regulatory as |
| Bibliography |
Includes bibliographical references and index |
| Notes |
CIP data; item not viewed |
| Subject |
Genetic toxicology.
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Drugs -- Toxicology.
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HEALTH & FITNESS -- Diseases -- General.
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MEDICAL -- Clinical Medicine.
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MEDICAL -- Diseases.
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MEDICAL -- Evidence-Based Medicine.
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MEDICAL -- Internal Medicine.
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Drugs -- Toxicology
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Genetic toxicology
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| Form |
Electronic book
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| Author |
Lee, Heewon, editor
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| ISBN |
9781439874219 |
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1439874212 |
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