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Pharmaceutical Stability Testing to Support Global Markets

  • Kim Huynh-Ba

Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)

Table of contents

  1. Front Matter
    Pages i-xix
  2. Section I

    1. Front Matter
      Pages 1-1
    2. Kim Huynh-Ba
      Pages 3-5
  3. Stability Studies in a Global Environment

    1. Front Matter
      Pages 8-8
    2. Gary Buehler, Kim Huynh-Ba
      Pages 9-13
    3. Justina A. Molzon
      Pages 15-22
    4. Sabine Kopp
      Pages 23-28
    5. Saranjit Singh, Amrit Paudel, Gaurav Bedse, Rhishikesh Thakare, Vijay Kumar
      Pages 37-44
    6. Lucky S. Slamet, Kim Huynh-Ba
      Pages 45-50
    7. Gary Buehler, Kim Huynh-Ba
      Pages 61-66
    8. Jeffrey T. Needels, Mary W. Seibel, Karen L. Lucas, Rachael Carlisle Roehrig
      Pages 67-73
    9. Horacio N. Pappa, Kim Huynh-Ba
      Pages 93-97
  4. Technical Concepts for Stability Program

    1. Front Matter
      Pages 100-100
    2. Mark A. Staples
      Pages 101-106
    3. Mansoor A. Khan
      Pages 123-133
    4. Mark D. Argentine, Patrick J. Jansen
      Pages 135-144
    5. Vilayat A. Sayeed, Abhay Gupta, Mansoor A. Khan
      Pages 153-160
    6. Jianmei Kochling, Juma Bridgewater, Redouan Naji
      Pages 169-179
  5. Stability Data and Operational Practices

  6. Back Matter
    Pages 259-265

About this book

Introduction

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 described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.

Keywords

Aspects Biotechn Huynh-Ba Markers Stability Support Testing biotechnology drug environment pharmaceutical research toxicology

Editors and affiliations

  • Kim Huynh-Ba
    • 1
  1. 1.Pharmalytik Consulting ServicesNewarkU.S.A.

Bibliographic information