Pharmaceutical Stress Testing
eBook - PDF

Pharmaceutical Stress Testing

Predicting Drug Degradation, Second Edition

  1. 624 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Pharmaceutical Stress Testing

Predicting Drug Degradation, Second Edition

About this book

The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability

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Yes, you can access Pharmaceutical Stress Testing by Steven W. Baertschi, Karen M. Alsante, Robert A. Reed in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2016
Print ISBN
9781439801796
eBook ISBN
9781439801802
Edition
2
Topic
Medicine
Subtopic
Pharmacology

Table of contents

  1. Front Cover
  2. Contents
  3. Contributors
  4. Preface
  5. Acknowledgments
  6. Chapter 1 Introduction
  7. Chapter 2 Stress testing: A predictive tool
  8. Chapter 3 Stress testing: The chemistry of drug degradation
  9. Chapter 4 Stress testing: Analytical considerations
  10. Chapter 5 Stress testing: Relation to the development timeline
  11. Chapter 6 Oxidative susceptibility testing
  12. Chapter 7 Photostability stress testing
  13. Chapter 8 Practical aspects of conducting photostability stress testing
  14. Chapter 9 Role of “mass balance” in pharmaceutical stress testing
  15. Chapter 10 Solid-state pharmaceutical development: Ensuring stability through salt and polymorph screening
  16. Chapter 11 Solid-state excipient compatibility testing
  17. Chapter 12 Small molecule parenteral drugs: Practical aspects of stress testing
  18. Chapter 13 Stability considerations in development of freeze-dried pharmaceuticals
  19. Chapter 14 Stress testing of therapeutic monoclonal antibodies
  20. Chapter 15 Stress testing of oligonucleotides
  21. Chapter 16 Stress testing to determine liposome degradation mechanisms
  22. Chapter 17 Stress testing of combination therapies
  23. Chapter 18 Rapid stress stability studies for evaluation of manufacturing changes, materials from multiple sources, and stability- indicating methods
  24. Chapter 19 Stress testing as a predictive tool for the assessment of potential genotoxic degradants
  25. Chapter 20 The power of computational chemistry to leverage stress testing of pharmaceuticals
  26. Chapter 21 Automation in conducting stress testing and excipient compatibility studies
  27. Chapter 22 Use of isothermal microcalorimetry in stress testing
  28. Chapter 23 Temperature excursions during shipment and storage
  29. Chapter 24 Stress testing: Frequently asked questions
  30. Index
  31. Back Cover