Handbook of Analytical Validation
Author:   Michael E. Swartz (Cambridge, Massachusetts, USA) ,  Ira S. Krull (Northeastern University, Boston, Massachusetts, USA)
Publisher:   Taylor & Francis Inc
ISBN:  

9780824706890


Pages:   220
Publication Date:   24 April 2012
Format:   Hardback
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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Handbook of Analytical Validation


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Author:   Michael E. Swartz (Cambridge, Massachusetts, USA) ,  Ira S. Krull (Northeastern University, Boston, Massachusetts, USA)
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Dimensions:   Width: 15.60cm , Height: 1.80cm , Length: 23.40cm
Weight:   0.521kg
ISBN:  

9780824706890


ISBN 10:   0824706897
Pages:   220
Publication Date:   24 April 2012
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

Introduction to Analytical Method Validation. Analytical Instrument Qualification. HPLC Method Development and Optimization with Validation in Mind. Method Validation Basics. Robustness and System Suitability. Setting Specifications and Investigating Out-of-Specification Results. Validation by Type of Method. Analytical Method Transfer. Implementing New Technology in a Regulated Environment. Glossary of Terms Related to Chromatographic Method Validation.

Reviews

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


Author Information

Michael E. Swartz, Ira S. Krull

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