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  • Book
    edited by Fenghe Qiu, Garry Scrivens.
    Digital : ScienceDirect2018
    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.