2009

Handbook of Stability Testing in Pharmaceutical Development

Regulations, Methodologies, and Best Practices

Editors:

ISBN: 978-0-387-85626-1 (Print) 978-0-387-85627-8 (Online)

Table of contents (17 chapters)

  1. Front Matter

    Pages I-XVII

  2. Introduction

    1. Front Matter

      Pages 1-1

    2. No Access

      Book Chapter

      Pages 1-6

      Introduction

  3. Stability Regulations

    1. Front Matter

      Pages 7-7

    2. No Access

      Book Chapter

      Pages 9-19

      Critical Regulatory Requirements for a Stability Program

    3. No Access

      Book Chapter

      Pages 21-41

      Understanding ICH Guidelines Applicable to Stability Testing

    4. No Access

      Book Chapter

      Pages 43-91

      Global Stability Practices

    5. No Access

      Book Chapter

      Pages 93-114

      Post-approval Changes – Stability Requirements and Regulations

    6. No Access

      Book Chapter

      Pages 115-135

      Understanding and Predicting Pharmaceutical Product Shelf-Life

  4. Stability Methodologies and Best Practices

    1. Front Matter

      Pages 137-137

    2. No Access

      Book Chapter

      Pages 139-161

      Development of Stability Indicating Methods

    3. No Access

      Book Chapter

      Pages 163-188

      Method Validation and Transfer

    4. No Access

      Book Chapter

      Pages 189-199

      Overview of USP-NF Requirements for Stability Purposes

    5. No Access

      Book Chapter

      Pages 201-221

      Non-chromatographic Methods to Support Stability Program

    6. No Access

      Book Chapter

      Pages 223-240

      Vibrational Spectroscopic Methods for Quantitative Analysis

    7. No Access

      Book Chapter

      Pages 241-261

      Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product

    8. No Access

      Book Chapter

      Pages 263-283

      Evaluation of Stability Data

    9. No Access

      Book Chapter

      Pages 285-302

      Qualification, Calibration, and Maintenance of Stability Chambers

    10. No Access

      Book Chapter

      Pages 303-320

      Stability Operation Practices

  5. Other Stability Programs

    1. Front Matter

      Pages 321-321

    2. No Access

      Book Chapter

      Pages 323-351

      Combination Products/Drugs in Devices

    3. No Access

      Book Chapter

      Pages 353-369

      Stability Studies for Biologics

  6. Back Matter

    Pages 371-389