Bookedited by Fenghe Qiu, Garry Scrivens.
Contents:
1. Accelerated predictive stability: an introduction
2. Regulatory expectations and industry practice on stability testing
3. Theory and fundamentals of accelerated predictive stability (APS) studies
4. Practical considerations
5. The humidity exposure of packaged products
6. Data evaluation and statistical methods
7. Strategies for improving the reliability of accelerated predictive stability (APS) studies
8. Integration of APS into a rapid, early clinical drug product development paradigm
9. Accelerated predictive stability (APS) regulatory strategies
10. Embedding APS within business
11. Implementing an accelerated predictive stability program
12. Accelerated stability assessment program (ASAP) applications in a postapproval environment
13. ASAP application: unstable drug candidate in early development
14. ASAP application in suspension, liquid, lyophilized, and controlled-release drug products
15. Applications of ASAP to generic drugs
16. ASAP application: nicotine lozenges
17. ASAP applications in clinical development: prediction of degradation and dissolution performance
18. Accelerated predictive stability (APS) applications: packaging strategies for controlling dissolution performance
19. Accelerated stability modeling: investigation of disintegration time of a drug product with sodium bicarbonate
20. Accelerated stability modeling: an ionic liquid drug product
21. Accelerated stability modeling: assay loss of nicotine lozenges
22. Accelerated stability modeling: desolvation of a solvate drug product.