Pharmaceutical Stress Testing

2005·9.86 MB·English

by  Steven W. Baertschi

Preface Page: xiii
Contents Page: xv
Contributors Page: xxi
Chapter 1. Introduction Page: 1
Chapter 2. Stress Testing: A Predictive Tool Page: 13
Chapter 3. Stress Testing: The Chemistry of Drug Degradation Page: 51
Chapter 4. Stress Testing: Analytical Considerations Page: 141
Chapter 5. Stress Testing: Relation to the Development Timeline Page: 173
Chapter 6. Role of ‘‘Mass Balance’’ in Pharmaceutical Stress Testing Page: 181
Chapter 7. Oxidative Susceptibility Testing Page: 205
Chapter 8. Comparative Stress Stability Studies for Rapid Evaluation of Manufacturing Changes or Mat Page: 235
Chapter 9. Physical and Chemical Stability Considerations in the Development and Stress Testing of F Page: 261
Chapter 10. Photostability Stress Testing Page: 293
Chapter 11. The Use of Microcalorimetry in Stress Testing Page: 327
Chapter 12. The Power of Computational Chemistry to Leverage Stress Testing of Pharmaceuticals Page: 355
Chapter 13. Solid-State Excipient Compatibility Testing Page: 419
Chapter 14. Stress Testing: Frequently Asked Questions Page: 459
Index Page: 471
Back Cover Page: B