Analytical Method Development and Validation
Analytical Method Development and Validation Books
Product Description
This concise guide delineates specific approaches to the successful development, optimization, and validation of high-quality HPLC-based analytical methods;demonstrating how these steps can be integrated into a formal administer shiny bestow United States Pharmacopeia (USP) set of laws and International Conference on Harmonization (ICH) contributions.
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This book is a very excellent basic (and comparatively inexpensive) introduction to the terms and definitions of method validation. Certainly worth the price until the next edition comes out in early 2007.
Protocol sugestions, and the bibliography are worth the price lonely.
Rating: 5 / 5
Very general description of the method validation administer. This book may possibly only be the first step in undestanding of the general requirements for the method validation administer. To deepen one’s knowledge, the reader should choose the books (e.g. Development and Validation of Analytical Methods by Christopher Riley) which are focused on explaining the concept from the scientific prospective.
Rating: 2 / 5
I have to admit being a bit disappointed with this book. The content is sound, based to a large extent on ICH guidance, and for the most part, applies concepts to HPLC analysis. The actual text starts on p17 and ends on p 83, with an average words/page <250 (there are likely less than 16000 words in the entire text). So my rating is biased by what I consider a poor value in terms of cost/content. By way of comparison, the ICH Q2A and Q2B comprise nearly 3700 words.
Although the book focuses on HPLC, the title concept also applies to other analytical methods (immunoassays, bioassays, mass spec., flow cytometry, etc.) There is clearly more to be learned on this topic. This text may be considered an intorductory primer, or a concise summary.
In retrospect, I would preferred to have spent more money to receive a more thorough text with applications in more diverse methods.
Rating: 3 / 5