Biotechnology: Pharmaceutical Aspects

Pharmaceutical Stability Testing to Support Global Markets

Editors: Huynh-Ba, Kim (Ed.)

  • Provides an understanding of the regulatory perspective of stability testing
  • Globally positions the stability program for the 21st century
  • Explores different stability related challenges, such as monitoring impurities, evaluating shipping excursions, setting specifications, estimating expiry
  • Stability is a crucial sector of the drug development process, since companies rely on the stability data to establish an expiry for marketed pharmaceutical products.
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eBook $199.00
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Hardcover $259.00
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  • ISBN 978-1-4419-0888-9
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  • Usually dispatched within 3 to 5 business days.
Softcover $259.00
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  • ISBN 978-1-4614-2536-6
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

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.

About the authors

Kim Huynh-Ba is the founder and Technical Director of Pharmalytik (www.pharmalytik.com). She has twenty two years of experience in various analytical areas of pharmaceutical development and a primary focus in stability sciences. Prior to Pharmalytik, she held positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She has been advising pharmaceutical companies including companies operating under Consent Decree on harmonization and optimization of analytical best practices since 2001.

In addition to her consulting activities, Kim is a short course instructor and organizer on topics ranging from cGMP compliance and quality issues to stability programs under sponsorship of global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, many other international training groups. She is the founder and past co-chair of the AAPS Stability Focus Group, and an active member of the Pharmaceutical Stability Discussion Group (PSDG). She serves on the Governing Board of Eastern Analytical Symposium (EAS). She currently is Chair of the AAPS APQ e-Learning Committee and the 2008 EAS Short Course Program. She is a member of USP's Prescription/Non-Prescription Stakeholder Forum and also USP Reference Standard Project Team.

Kim Huynh-Ba is a recipient of the 2008 AAPS APQ Service Award and 2008 Recognition Award of AAPS Regulatory Section. She also received the 2001 DPCAA Leadership Award.

Kim Huynh-Ba has authored numerous technical publications and book chapters. She is invited frequently to present at national and international conferences. She is the editor of the Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices, which has been recognized as a practical reference book in the stability community.

Table of contents (31 chapters)

  • Introduction

    Huynh-Ba, Kim

    Pages 3-5

  • Regulatory Perspectives on Product Stability

    Buehler, Gary (et al.)

    Pages 9-13

  • Current International Harmonization Efforts

    Molzon, Justina A.

    Pages 15-22

  • Update on the WHO Stability Guideline

    Kopp, Sabine

    Pages 23-28

  • Development of a Regional Guideline for the Eastern Mediterranean Region

    Saleh, Abdel Aziz (et al.)

    Pages 29-35

Buy this book

eBook $199.00
price for USA (gross)
  • ISBN 978-1-4419-0889-6
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $259.00
price for USA
  • ISBN 978-1-4419-0888-9
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $259.00
price for USA
  • ISBN 978-1-4614-2536-6
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Pharmaceutical Stability Testing to Support Global Markets
Editors
  • Kim Huynh-Ba
Series Title
Biotechnology: Pharmaceutical Aspects
Series Volume
XII
Copyright
2010
Publisher
Springer-Verlag New York
Copyright Holder
Springer-Verlag New York
Distribution Rights
Distribution rights for India: Mehul Book Sales, Mumbai, India
eBook ISBN
978-1-4419-0889-6
DOI
10.1007/978-1-4419-0889-6
Hardcover ISBN
978-1-4419-0888-9
Softcover ISBN
978-1-4614-2536-6
Edition Number
1
Number of Pages
XX, 266
Number of Illustrations and Tables
7 b/w illustrations, 4 illustrations in colour
Topics