Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best PracticesISBN: 978-0387856261 (Springer Publishing)
K. Huynh-Ba (ed.), Pharmalytik, Newark, DE
A comprehensive and practical guide to Stability Testing in Pharmaceutical Development
Stability testing is required to demonstrate the pharmaceutical product meets its acceptance criteria throughout its shelf life, and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality and regulatory affairs.
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners. Read more...
Quoted Feedbacks:
"Thank you for your excellent textbook. I use it frequently as a resource."
Joan Garapolo, Stability Operations Manager, Abbott Labs, Lake County, IL
"…a lot of very helpful, interesting, and well-written information…"
Steve Baertschi, Research Fellow, Eli Lilly, Indianapolis, IN
"Thorough, organized, and updated....this authoritative text on stability testing is written by experts who understand both best practices and regulatory aspects."
Michael Dong, Senior Scientist, Genentech, San Francisco, CA
"…one of the best existing extensive combination of theory, practice, regulations…"
Marina Senko, Associate Director, Othera, Chadds Ford, PA
Pharmaceutical Stability Testing to Support Global Markets ISBN: 978-1-4419-0888-9
(Springer Publishing - expected in November 2009)
K. Huynh-Ba (ed.), Pharmalytik, Newark, DE
On September 10-12 in Bethesda MD, featuring 45 speakers of pharmaceutical industry and world wide regulatory agencies, AAPS Stability Workshop "Pharmaceutical Stability Testing To Support Global Markets" has drawn close to 300 scientists worldwide.
Topics of discussion include global regulations, impurities monitoring, establishing specifications, biologics stability, challenges of OTC and generics, quality by design, physicochemical stability, etc...
Workshop summary is made available.
These documents are provided as a service to communicate industry news. Pharmalytik holds no responsibility nor endorsements with regards to their content.
- Draft WHO Guidelines - Pharmaceutical Development for Multisource Products – June 2010
- Draft WHO Guidelines - Storage and Transport Products – June 2010
- WHO Guidelines - Stability Testing of active pharmaceutical ingredients and finished pharmaceutical products – Aug 2009 –
Courtesy of Dr. S. Kopp, WHO
- Draft WHO Good Practices for Pharmaceutical Quality Control Laboratories – May 2009 –
Courtesy of Dr. S. Kopp, WHO
- Draft WHO Stability Guideline v 3, Sept 2008 -
Courtesy of Dr. S. Kopp, WHO
- WHO GMP API - Proposed for Revision - Sept 2007
- Recent Developments on Long-Term Stability Test Conditions, The Pharma Review, December 2006 - Review article -
courtesy of Dr. S. Singh, NIPER.
- Draft Regional Stability Guideline for the WHO Eastern Mediterranean Region (EMR), version 2.0, dated 19 April 2006 -
courtesy of Dr. M. Zahn, 3R Pharma.
- Panama Stability Guidelines, dated 9 November 2005
- ASEAN Stability Guidelines, dated 22 Feb 2005 - courtesy of Dr. L. Slamet, Indonesia.
- Brazil - English, dated 1 Aug 2005
- China - CP App XX C - Stability Guidelines - English, dated July 2005
- Mexico NOM-073-SSA1-2005 - English, dated 04 Jan 2006
- Saudi Arabia - Draft, dated May 2005
- WHO Technical Report Series 908, Geneva 2003
- Climatic Zone Classification, extracted from W.Grimm (1993) publication.
- Pharm Tech: Forced Degradation, 2002
- Pharm Tech: Out-of-Trend I, 2003
- Pharm Tech: Out-of-Trend II, 2005
