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...
| Συγγραφή απο Οργανισμό/Αρχή: | |
|---|---|
| Άλλοι συγγραφείς: | |
| Μορφή: | Ηλεκτρονική πηγή Ηλ. βιβλίο |
| Γλώσσα: | English |
| Έκδοση: |
New York, NY :
Springer New York,
2010.
|
| Σειρά: | Biotechnology: Pharmaceutical Aspects ;
XII |
| Θέματα: | |
| Διαθέσιμο Online: | Full Text via HEAL-Link |
Πίνακας περιεχομένων:
- 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.
