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Handbook of Analytical Validation, by Michael E. Swartz, Ira S. Krull
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Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:
- Contains practical, up-to-date guidelines for analytical method validation
- Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications
- Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment
Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.
- Sales Rank: #1032744 in Books
- Brand: Brand: CRC Press
- Published on: 2012-04-24
- Original language: English
- Number of items: 1
- Dimensions: 9.20" h x .70" w x 6.10" l, 1.05 pounds
- Binding: Hardcover
- 220 pages
- Used Book in Good Condition
Review
"The authors are to be congratulated on producing a concise, readable and informative book. It is a really useful reference asset covering current regulatory requirements on the validation of new or modified analytical methods from a practical viewpoint. I have seen books of almost twice the size containing half the information. This book should be an integral part of all drug and biotechnology laboratories for both training staff and for comprehensive advice on how to deal with a very wide range of specific issues relating to AMV."
―www.chemistryworld.org 1 November 2012 1 Chemistry World 163
About the Author
Northeastern University, Boston, Massachusetts, USA Synomics Pharmaceuticals Svcs LLC, Massachusetts, USA
Most helpful customer reviews
0 of 0 people found the following review helpful.
Three Stars
By Melissa Marquez
The entries are not very detailed and it's really nothing you can't find in the ICH guidelines
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Five Stars
By GEORGE IBRAHIM
It explains the sophisticated Academic Science in a very simple way.
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Five Stars
By Bruce Campbell
It's amazing!
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