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Pharmaceutical Stress Testing Book from C.H.I.P.S.

Pharmaceutical Stress Testing
Predicting Drug Degradation
Second edition
edited by Steven Baertschi

This new second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for traditional drug substances.

This is the only guide available to tackle this subject in-depth. The new edition has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years.

Contents

  1. Introduction
  2. Stress Testing: A Predictive Tool
  3. The Chemistry of Drug Degradation
  4. Stress Testing: Analytical Considerations
  5. Relation to the Development Timeline
  6. Oxidative Susceptibility Testing
  7. Photostability Stress Testing
  8. Practical Aspects of Conducting Photostability Stress Testing
  9. Role of ‘‘Mass Balance’’ in Pharmaceutical Stress Testing
  10. Solid-State Pharmaceutical Development: Ensuring Stability Through Salt and Polymorph Screening
  11. Solid-State Excipient Compatibility Testing
  12. Small Molecule Parenteral Drugs: Practical Aspects of Stress Testing
  13. Stability Considerations in Development of Freeze Dried Pharmaceuticals
  14. Stress Testing of Therapeutic Monoclonal Antibodies
  15. Stress Testing of Oligonucleotides
  16. Stress Testing to Determine Liposome Degradation Mechanisms
  17. Stress Testing of Combination Therapies
  18. Comparative Stress Stability Studies for Rapid Evaluation of Manufacturing Changes or Materials from Multiple Sources
  19. Stress Testing as a Predictive Tool for the Assessment of Potential Genotoxic Degradants
  20. The Power of Computational Chemistry to Leverage Stress Testing of Pharmaceuticals
  21. Use of Automation in Conducting Stress Testing and Excipient Compatibility Studies
  22. The Use of Microcalorimetry in Stress Testing
  23. Stress Testing as it Relates to Shipping / Distribution – Real World Measurements and Implications
  24. Stress Testing: Frequently Asked Questions

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Pharmaceutical Stress Testing
Predicting Drug Degradation
Second edition
edited by Steven Baertschi

2011 • 504 pages • $328.95 + shipping
Texas residents please add 6.75 % sales tax

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