Pharmaceutical Stability Testing to Support Global Markets

Editors:

ISBN: 978-1-4419-0888-9 (Print) 978-1-4419-0889-6 (Online)

Table of contents (31 chapters)

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  1. Front Matter

    Pages i-xix

  2. Section I

    1. Front Matter

      Pages 1-1

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      Book Chapter

      Pages 3-5

      Introduction

  3. Stability Studies in a Global Environment

    1. Front Matter

      Pages 8-8

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      Pages 9-13

      Regulatory Perspectives on Product Stability

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      Pages 15-22

      Current International Harmonization Efforts

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      Pages 23-28

      Update on the WHO Stability Guideline

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      Pages 29-35

      Development of a Regional Guideline for the Eastern Mediterranean Region

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      Pages 37-44

      The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India

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      Pages 45-50

      Requirements for South East Asian Markets

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      Pages 51-60

      The Role of USP Monographs in Stability Testing

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      Book Chapter

      Pages 61-66

      Regulatory Requirements for Stability Testing of Generics

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      Book Chapter

      Pages 67-73

      Stability Design for Consumer Healthcare Products

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      Book Chapter

      Pages 75-83

      Challenges of Drug/Devices Pharmaceutical Products

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      Book Chapter

      Pages 85-91

      Practical Challenges of Stability Testing of Nutraceutical Formulations

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      Book Chapter

      Pages 93-97

      Setting Tolerances for Instrument Qualification USP Chapter <1058>

  4. Technical Concepts for Stability Program

    1. Front Matter

      Pages 100-100

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      Book Chapter

      Pages 101-106

      The Concept of Quality-by-Design

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      Pages 107-116

      Forced Degradation and Its Relation to Real Time Drug Product Stability

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      Pages 117-121

      Low Level Impurities in Drug Substances and Drug Products and the Analytical Challenges in Identification and Quantitation

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      Pages 123-133

      Stability of Repackaged Products

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      Pages 135-144

      Packaging-Induced Interactions and Degradation

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      Book Chapter

      Pages 145-152

      An Overview of Physical Stability of Pharmaceuticals

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      Book Chapter

      Pages 153-160

      Stability of Split Tablets

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