Accelerated predictive stability (APS) : fundamentals and pharmaceutical industry practices /

"Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Qiu, Fenghe (Editor ), Scrivens, Garry (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London, United Kingdom : Academic Press, an imprint of Elsevier, 2018.
Temas:
Drug stability > Statistical methods.
Pharmaceutical industry.
Prediction theory.
Drug stability.
Drug Industry > standards
Drug Stability
Drug Industry
M�edicaments > Stabilit�e > M�ethodes statistiques.
Industrie pharmaceutique.
Th�eorie de la pr�evision.
M�edicaments > Stabilit�e.
MEDICAL > Pharmacology.
Drug stability
Pharmaceutical industry
Prediction theory
Internet Resources.
Charts.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.

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