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Pharmaceutical Stability Testing to Support Global Markets Pdf Free

Pharmaceutical Stability Testing to Support Global Markets: This book is written by Kim Huynh-Ba which you can download freely in pdf format. The International Conference on Harmonization (ICH) has worked on the harmonization of stability standards in the US, Europe, and Japan since the early 1990s. Although the Q1A(R2) Stability Guidelines were issued for more than a decade, issues related to this field continue to arise as the principles outlined in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and seek ways to harmonize regulatory requirements, streamline practices, and improve processes to bring safe and effective medical supplies to patients around the world.

In 2007, the American Association of Pharmaceutical Scientists (AAPS) Focus Group on Stability organized two workshops: the Stability Workshop and the Degradation Mechanisms Workshop. These meetings attracted many industry scientists as well as representatives from various regulatory agencies from around the world to discuss important issues related to pharmaceutical stability practices.

Recognizing the importance of documenting these discussions and with permission from AAPS, I have worked with speakers to put together a 30-article collection of presentations made at these two meetings, primarily the Stability Workshop. I trust this book will be of benefit to all of you by providing guidance and up-to-date information for developing quality stability programs.


Book Name Pharmaceutical Stability Testing to Support Global Markets
Author of Book Kim Huynh-Ba
Edition 1st
Language English
Format PDF
Category Pharmaceuticals Books


Overview of Pharmaceutical Stability Testing to Support Global Markets Pdf Free

According to Kim Huynh-Ba, the articles in this book are based on presentations given at the AAPS Workshop on “Pharmaceutical Stability Testing to Support Global Markets” in Bethesda, Maryland, September 10-12, 2007. This workshop brought together 45 speakers from the United States and internationally, representing the four different climatic zones. Its content attracted more than 350 attendees from around the world. The authors discussed current trends in global stability testing and presented specific technical issues that still need to be resolved to fully harmonize stability practices.

Stability is a critical quality attribute of all pharmaceutical products and therefore stability testing is a crucial component of the drug development process. Companies rely on stability data to establish the shelf life of marketed pharmaceuticals and ensure drug efficacy and safety. Many guidelines have been written in this field; however, new problems continue to pose and challenge established practices.


Topics of this Edition

Section I
• Introduction
Section II
Stability Studies in a Global Environment
• Regulatory Perspectives on Product Stability
• Current International Harmonization Efforts
• Update on the WHO Stability Guideline
• Development of a Regional Guideline for the Eastern Mediterranean Region
• The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India
• Requirements for southeast Asian Markets
• The Role of USP Monographs in Stability Testing
• Regulatory Requirements for Stability Testing of Generics
• Stability Design for Consumer Healthcare Products
• Challenges of Drug/Devices Pharmaceutical Products
• Practical Challenges of Stability Testing of Nutraceutical Formulations
• Setting Tolerances for Instrument Qualification USP Chapter <1058>
Section III
Technical Concepts for Stability Program
• The Concept of Quality-by-Design
• Forced Degradation and Its Relation to Real-Time Drug Product Stability
• Low-Level Impurities in Drug Substances and Drug Products and the Analytical Challenges in Identification and     Quantitation

About the Author

Kim Huynh-Ba is the founder and CTO of Pharmalytik ( He has 22 years of experience in various analytical areas of pharmaceutical development with a primary focus on stability sciences. Prior to Pharmalytik, he held drug development roles at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb, and Wyeth Vaccines. He has been advising pharmaceutical companies, including companies operating under the Consent Decree, on the harmonization and optimization of best analytical practices since 2001.

In addition to her consulting activities, Kim is an instructor and organizer of short courses on topics ranging from cGMP compliance and quality issues to stability programs under the auspices of global organizations such as the American Chemical Society (ACS), the Association American Pharmaceutical Scientists (AAPS), Pittsburgh Conference, many other international training groups. She is the founder and former co-chair of the AAPS Stability Focus Group and an active member of the Pharmaceutical Stability Discussion Group (PSDG). He is a member of the Eastern Analytical Symposium (EAS) Governing Board. She is currently the Chair of the AAPS APQ e-Learning Committee and the 2008 EAS Short Course Program. She is a member of the USP Prescription/Non-Prescription Stakeholder Forum and also the USP Reference Standards Project Team. . She is a Visiting Professor at Rowan University and an Adjunct Professor in the Professional Master of Science Program in Analytical Chemistry at the Illinois Institute of Technology.



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