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Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices
ISBN: 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.
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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 - 2010)
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...
PDF weblink

Workshop summary is made available.
PDF weblink



 Recent Publications 


Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. (12-2013)
Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms
AAPS Pharm SciTech (2013)
AAPS.  Published online: 27 November 2013.

The final publication is available at link.springer.com.


Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. (12-2013)
Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape
AAPS Pharm SciTech (2013)
AAPS.  Published online: 21 December 2013.

The final publication is available at link.springer.com.


Note: The above publications summarized an AAPS workshop on Impurities held in October 2012 in Chicago, Illinois.


 Global Documents 


These documents are provided as a service to communicate industry news. Pharmalytik holds no responsibility nor endorsements with regards to their content.
  • FDA Guidance on Method Validation for Drugs and Biologics (February 2014) PDF weblink
  • WHO guidance on variation to multisource (generic) pharmaceutical products (February 2014) PDF weblink
  • FDA SUPAC draft guidance (01-April-2013) PDF weblink
  • WHO Guidelines on submission for Multisource (Generic) finished product: Quality Section (01-Mar-2013) PDF weblink
  • WHO Updated Text for WHO GMP for Pharmaceutical Products (24-Jan-2013) PDF weblink
  • FDA Guidance for ANDs” Stability Testing of Drug Substances and Products – Draft (19-Oct-2012) PDF weblink
  • WHO Guideline on Quality Risk Management (31-Aug-2012) PDF weblink
  • ASEAN Guidelines – Draft 3 (27-Jul-2012) PDF weblink
  • WHO Expert Committee on Specifications for Pharmaceutical Preparations (45th report) PDF weblink
  • Generic Submission Guideline-Quality (03 Jun 2011) PDF weblink
  • Pharmaceutical development of multisource (generic) FPPs - points to consider – Comments requested PDF weblink
  • Draft WHO Guidelines - Pharmaceutical Development for Multisource Products – June 2010 PDF weblink
  • Draft WHO Guidelines - Storage and Transport Products – June 2010 PDF weblink
  • WHO Guidelines - Stability Testing of active pharmaceutical ingredients and finished pharmaceutical products – August 2009 – Courtesy of Dr. S. Kopp, WHO PDF weblink
  • Draft WHO Good Practices for Pharmaceutical Quality Control Laboratories – May 2009 – Courtesy of Dr. S. Kopp, WHO PDF weblink
  • Draft WHO Stability Guideline v 3, Sept 2008 - Courtesy of Dr. S. Kopp, WHO PDF weblink
  • WHO GMP API - Proposed for Revision - Sept 2007 PDF weblink
  • Recent Developments on Long-Term Stability Test Conditions, The Pharma Review, December 2006 - Review article - courtesy of Dr. S. Singh, NIPER. PDF weblink
  • 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. PDF weblink
  • Panama Stability Guidelines, dated 9 November 2005 PDF weblink
  • ASEAN Stability Guidelines, dated 22 Feb 2005 - courtesy of Dr. L. Slamet, Indonesia. PDF weblink
  • Brazil - English, dated 1 Aug 2005 PDF weblink
  • China - CP App XX C - Stability Guidelines - English, dated July 2005 PDF weblink
  • Mexico NOM-073-SSA1-2005 - English, dated 04 Jan 2006 PDF weblink
  • Saudi Arabia - Draft, dated May 2005 PDF weblink
  • WHO Technical Report Series 908, Geneva 2003 PDF weblink
  • Climatic Zone Classification, extracted from W.Grimm (1993) publication. PDF weblink
  • Pharm Tech: Forced Degradation, 2002 PDF weblink
  • Pharm Tech: Out-of-Trend I, 2003 PDF weblink
  • Pharm Tech: Out-of-Trend II, 2005 PDF weblink

Highlights

  • Coming soon.

"Introduction of Pharmaceutical Analysis"

Expected in September 2016,
John Wiley & Sons Publisher.

by K. Huynh-Ba (ed.)



Pharmaceutical Stability Testing to Support Global Markets

February 2010,
Springer Publisher & AAPS.

by K. Huynh-Ba (ed.)



"Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices"

November 2008,
Springer Publisher.

by K. Huynh-Ba (ed.)


Contact Info



Pharmalytik

Newark, DE USA


info@pharmalytik.com


(302) 731-9959