Pharmaceutical Industry Practices on Genotoxic Impurities
eBook - ePub

Pharmaceutical Industry Practices on Genotoxic Impurities

  1. 536 pages
  2. English
  3. ePUB (mobile friendly)
  4. 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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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 Medicine & Science Research & Methodology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2014
Print ISBN
9781439874202
eBook ISBN
9781040162392
Topic
Medicine
Subtopic
Science Research & Methodology

Table of contents

  1. Cover
  2. Half Title
  3. Chromatographic Science Series
  4. Title Page
  5. Copyright Page
  6. Dedication
  7. Table of Contents
  8. Preface
  9. Editor
  10. List of Contributors
  11. Chapter 1 Overview of Regulatory Guidelines on Impurities and Genotoxic Impurities
  12. Chapter 2 Structural Alerts for Genotoxicity and Carcinogenicity
  13. Chapter 3 Acceptable Exposure Calculations for Impurities and Selected Compounds from the Carcinogenic Potency Database
  14. Chapter 4 Genotoxic Impurities from Toxicology Perspectives Including
  15. Chapter 5 In Silico/Computational Assessment for the Evaluation of Genotoxic Impurities
  16. Chapter 8 Analysis of Genotoxic Impurities in Pharmaceuticals by Gas Chromatography-Mass Spectrometry
  17. Chapter 7 Purification of Lead Compounds for Early Toxicology Profiling such as Ames and Short-Term Non-GLP (Good Laboratory Practice) Toxicology Tests
  18. Chapter 8 Analysis of Genotoxic Impurities in Pharmaceuticals by Gas Chromatography-Mass Spectrometry
  19. Chapter 9 Control of Chloroethane in Raw Materials and Drug Substances Using Headspace/Gas Chromatography Analysis
  20. Chapter 10 Quantification of Genotoxic Impurities in Active Pharmaceutical Ingredients
  21. Chapter 11 Analytical Testing and Control for Genotoxic Impurities in Drug Substances
  22. Chapter 12 Approaches to Assess, Analyze, and Control Genotoxic Impurities in Drug Substance Development
  23. Chapter 13 Control and Analysis of Genotoxic Impurities in Drug Substance Development
  24. Chapter 14 Salt Formation of Pharmaceutical Compounds and Associated Genotoxic Risks
  25. Chapter 15 Identification and Control of Genotoxic Degradation Products
  26. Chapter 16 Identification and Qualification of Genotoxic Impurities as Leachables in Drug Products
  27. Chapter 17 Pharmaceutical Industry Survey on Genotoxic Impurities and Pharmaceutical Industry Survey on Genotoxic Impurities and Related Topics
  28. Index
  29. Notes