- 536 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
Pharmaceutical Industry Practices on Genotoxic Impurities
About this book
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, interpretati
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Table of contents
- Cover
- Half Title
- Chromatographic Science Series
- Title Page
- Copyright Page
- Dedication
- Table of 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
- Chapter 5 In Silico/Computational Assessment for the Evaluation of Genotoxic Impurities
- Chapter 8 Analysis of Genotoxic Impurities in Pharmaceuticals by Gas Chromatography-Mass Spectrometry
- 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 Ingredients
- 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 Risks
- 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 Pharmaceutical Industry Survey on Genotoxic Impurities and Related Topics
- Index
- Notes
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Yes, you can access Pharmaceutical Industry Practices on Genotoxic Impurities by Heewon Lee in PDF and/or ePUB format, as well as other popular books in Technology & Engineering & Toxicology. We have over 1.5 million books available in our catalogue for you to explore.