Written for practitioners in drug and biotechnology industries, this title is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. It offers the regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. "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