Handbook of Stability Testing in Pharmaceutical Development Regulations, Methodologies, and Best Practices /

A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stab...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Huynh-Ba, Kim (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: New York, NY : Springer New York : Imprint: Springer, 2009.
Edición:1st ed. 2009.
Temas:
Pharmacology.
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • Stability Regulations
  • Critical Regulatory Requirements for a Stability Program
  • Understanding ICH Guidelines Applicable to Stability Testing
  • Global Stability Practices
  • Post-approval Changes - Stability Requirements and Regulations
  • Understanding and Predicting Pharmaceutical Product Shelf-Life
  • Stability Methodologies and Best Practices
  • Development of Stability Indicating Methods
  • Method Validation and Transfer
  • Overview of USP-NF Requirements for Stability Purposes
  • Non-chromatographic Methods to Support Stability Program
  • Vibrational Spectroscopic Methods for Quantitative Analysis
  • Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product
  • Evaluation of Stability Data
  • Qualification, Calibration, and Maintenance of Stability Chambers
  • Stability Operation Practices
  • Other Stability Programs
  • Combination Products/Drugs in Devices
  • Stability Studies for Biologics.

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