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  • Book
    edited 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.
    Digital Access ScienceDirect 2018