Pharmaceutical Stability Testing to Support Global Markets

Table of Contents

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   Book Overview
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   Chapter 1 Introduction
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   Chapter 2 Regulatory Perspectives on Product Stability
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   Chapter 3 Current International Harmonization Efforts
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   Chapter 4 Update on the WHO Stability Guideline
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   Chapter 5 Development of a Regional Guideline for the Eastern Mediterranean Region
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   Chapter 6 The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India
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   Chapter 7 Requirements for South East Asian Markets
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   Chapter 8 The Role of USP Monographs in Stability Testing
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    Chapter 9 Regulatory Requirements for Stability Testing of Generics
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    Chapter 10 Stability Design for Consumer Healthcare Products
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    Chapter 11 Challenges of Drug/Devices Pharmaceutical Products
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    Chapter 12 Practical Challenges of Stability Testing of Nutraceutical Formulations
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    Chapter 13 Setting Tolerances for Instrument Qualification USP Chapter <1058>
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    Chapter 14 The Concept of Quality-by-Design
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    Chapter 15 Forced Degradation and Its Relation to Real Time Drug Product Stability
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    Chapter 16 Low Level Impurities in Drug Substances and Drug Products and the Analytical Challenges in Identification and Quantitation
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    Chapter 17 Stability of Repackaged Products
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    Chapter 18 Packaging-Induced Interactions and Degradation
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    Chapter 19 An Overview of Physical Stability of Pharmaceuticals
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    Chapter 20 Stability of Split Tablets
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    Chapter 21 Temperature Monitoring During Shipment and Storage
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    Chapter 22 Introducing a Science-Based Quality by Design Concept to Analytical Methods Development
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    Chapter 23 Optimizing Stability Data Package to Facilitate NDA/MAA Approval
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    Chapter 24 Maximize Data for Post Approval Changes
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    Chapter 25 Use of Statistics to Establish a Stability Trend: Matrixing
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    Chapter 26 Setting Specifications for Drug Substances
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    Chapter 27 Setting Specifications for Drug Products
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    Chapter 28 Highlights of Investigating Out-of-Specifications Test Results
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    Chapter 29 Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs
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    Chapter 30 Building and Developing of Relationships with Third Party Laboratories
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    Chapter 31 Outsourcing Stability Testing: A Tool for Resource and Risk Management