Analytical Method Development and Validation [Paperback]

Michael E. Swartz (Editor), Ira S. Krull (Editor)

Book Description

Publication Date: May 16, 1997 | ISBN-10: 0824701151 | ISBN-13: 978-0824701154 | Edition: 1

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

Editorial Reviews

Review

. . .a useful primer-type book covering validation of analytical methods. . . .recommended.
---Analyst
Stop and read this. . .book to understand a formal way to develop or to improve and validate your methods. . .. In answer to any query posed to you about your methods development technique, you could hand your well-worn copy of this small book to the questioner. There should be no further questions.
---INFORM

Product Details

• Paperback: 96 pages
• Publisher: CRC Press; 1 edition (May 16, 1997)
• Language: English
• ISBN-10: 0824701151
• ISBN-13: 978-0824701154
• Product Dimensions: 8.2 x 6 x 0.2 inches
• Shipping Weight: 2.4 ounces (View shipping rates and policies)
• Average Customer Review: 3.3 out of 5 stars  See all reviews (3 customer reviews)
• Amazon Best Sellers Rank: #1,534,870 in Books (See Top 100 in Books)

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Customer Reviews

Most Helpful Customer Reviews

2 of 2 people found the following review helpful:

3.0 out of 5 stars Limited scope, September 30, 2007

By 

S. Clark - See all my reviews
(REAL NAME)   

This review is from: Analytical Method Development and Validation (Paperback)

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 begins 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 almost 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.

4 of 5 people found the following review helpful:

2.0 out of 5 stars Analytical Method Development and Validation, July 24, 2006

By 

Aleksandr Gorbenko - See all my reviews
(REAL NAME)   

This review is from: Analytical Method Development and Validation (Paperback)

Very general description of the method validation process. This book could only be the first step in undestanding of the general requirements for the method validation process. 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.

5.0 out of 5 stars Great Introduction, October 11, 2006

By 

Doc Analytical (Northeast USA) - See all my reviews

This review is from: Analytical Method Development and Validation (Paperback)

This book is a very good 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 alone.