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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