Pharmaceutical Stability Testing to Support Global Markets

The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles...

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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, 2010.
Edición:1st ed. 2010.
Colección:Biotechnology: Pharmaceutical Aspects ; XII
Temas:
Pharmacology.
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • Section I
  • Stability Studies in a Global Environment
  • Regulatory Perspectives on Product Stability
  • Current International Harmonization Efforts
  • Update on the WHO Stability Guideline
  • Development of a Regional Guideline for the Eastern Mediterranean Region
  • The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India
  • Requirements for South East Asian Markets
  • The Role of USP Monographs in Stability Testing
  • Regulatory Requirements for Stability Testing of Generics
  • Stability Design for Consumer Healthcare Products
  • Challenges of Drug/Devices Pharmaceutical Products
  • Practical Challenges of Stability Testing of Nutraceutical Formulations
  • Setting Tolerances for Instrument Qualification USP Chapter
  • Technical Concepts for Stability Program
  • The Concept of Quality-by-Design
  • Forced Degradation and Its Relation to Real Time Drug Product Stability
  • Low Level Impurities in Drug Substances and Drug Products and the Analytical Challenges in Identification and Quantitation
  • Stability of Repackaged Products
  • Packaging-Induced Interactions and Degradation
  • An Overview of Physical Stability of Pharmaceuticals
  • Stability of Split Tablets
  • Temperature Monitoring During Shipment and Storage
  • Introducing a Science-Based Quality by Design Concept to Analytical Methods Development
  • Stability Data and Operational Practices
  • Optimizing Stability Data Package to Facilitate NDA/MAA Approval
  • Maximize Data for Post Approval Changes
  • Use of Statistics to Establish a Stability Trend: Matrixing
  • Setting Specifications for Drug Substances
  • Setting Specifications for Drug Products
  • Highlights of Investigating Out-of-Specifications Test Results
  • Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs
  • Building and Developing of Relationships with Third Party Laboratories
  • Outsourcing Stability Testing: A Tool for Resource and Risk Management.

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