Copyright o 2004 by John Wiley Sons, Inc. All rights reserve Published by John Wiley Sons, Inc, Hoboken, New Jersey Published simultaneously in Canada. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, cept as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc, 222 Rosewood Drive, Danvers, Ma01923,978-750-8400,fax978-646-8600,oronthewebatwww.copyright.com.Requeststo the Publisher for permission should be addressed to the Permissions Department, John Wiley Sons, Inc, 111 River Street, Hoboken, NJ 07030,(201)748-6011, fax(201)748-6008. Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales repres presentatives or written sales materials. The advice and strategies contained herein may not be suitable for your situation. You should consult with a professional where appropriate. Neither the publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. For general information on our other products and services please contact our Customer Care Department within the U.S. at 877-762-2974, outside the U.S. at 317-572-3993 or fax317-572-4002 wiley also publishes its books in a variety of electronic formats. Some content that appears in print, however, may not be available in electronic format. Library of Congress Cataloging-in-Publication Data: Analytical method validation and instrument performance verification Chung Chow Chan... et al. J Includes bibliographical references and index. ISBN 0-471-259535(cloth: alk. 1. Drugs-Analysis-Methodology-Evaluation. 2. Laboratories-Equipment and supplies-Evaluation. 3. Laboratories-Inst ts-Evaluation DNLM: 1. Chemistry, Pharmaceutical-instrumentation. 2. Chemistry, Pharmaceutical-methods. 3. Clinical Laboratory Techniques-standards 4. Technology, Pharmaceutical-methods QV 744 A532 2004]I Chan, RS189A5682004 61028-dc21 2003014141 Printed in the United States of AmericaCopyright  2004 by John Wiley & Sons, Inc. All rights reserved. Published by John Wiley & Sons, Inc., Hoboken, New Jersey. Published simultaneously in Canada. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400, fax 978-646-8600, or on the web at www.copyright.com. Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, (201) 748-6011, fax (201) 748-6008. Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives or written sales materials. The advice and strategies contained herein may not be suitable for your situation. You should consult with a professional where appropriate. Neither the publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. For general information on our other products and services please contact our Customer Care Department within the U.S. at 877-762-2974, outside the U.S. at 317-572-3993 or fax 317-572-4002. Wiley also publishes its books in a variety of electronic formats. Some content that appears in print, however, may not be available in electronic format. Library of Congress Cataloging-in-Publication Data: Analytical method validation and instrument performance verification / Chung Chow Chan ...[et al.]. p. ; cm. Includes bibliographical references and index. ISBN 0-471-25953-5 (cloth : alk. paper) 1. Drugs—Analysis—Methodology—Evaluation. 2. Laboratories—Equipment and supplies—Evaluation. 3. Laboratories— Instruments—Evaluation. [DNLM: 1. Chemistry, Pharmaceutical—instrumentation. 2. Chemistry, Pharmaceutical—methods. 3. Clinical Laboratory Techniques—standards. 4. Technology, Pharmaceutical—methods. QV 744 A532 2004] I. Chan, Chung Chow. RS189.A568 2004 610
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