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

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

Edited by Kim Huynh-Ba


In my professional career as a pharmaceutical scientist, I have been involved with severalaspectsofthe drugdevelopmentprocessfrompre-INDto commercialization and, somehow, I usually found myself coming back to a stability-related issue.

The stability area seemed to draw my utmost interest because in my day-to-day work, my opportunities involved more than one product, and none of the issues were the same.Eachsituationposedchallengesthatusuallyrequiredanexerciseofjudgment, an understandingof regulations,a knowledgeof science, a graspof compliance,and an appreciation of common practices.

Sinceearly2000,Ihavealsobeeninvolvedwithseveraltrainingopportunitiesand I struggled to ?nd good, concise, practical resources, one of which I could just hand to a new scientist who wishes to gain a greater understanding of stability sciences.

In addition, I encountered the same questions posted over and over on different stability best practices discussion forums.

As a book lover, I also have a good collection of technical books.

Unfor- nately, most of the stability related volumes are outdated.

Many of these materials are theoretical and do not contain much practical information. I understand that the pharmaceutical industry during this period is quite volatile, and guidelines are changingrapidlywhileregulatoryagenciesareworkingcloselywiththepharmac- tical industryto accommodatethese changes;however,thefundamentalinformation continues to remain quite the same, just as current Good Manufacturing Practices (cGMP) continue to be the standard industry practice.

Therefore, I hoped to ass- ble a practical handbook to ?ll this void.


  • Format: Hardback
  • Pages: 389 pages, 98 Tables, black and white; 72 Illustrations, black and white; XVII, 389 p. 72 illus.
  • Publisher: Springer-Verlag New York Inc.
  • Publication Date:
  • Category: Pharmacology
  • ISBN: 9780387856261



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