tailieunhanh - ANALYTICAL TECHNIQUES FOR BIOPHARMACEUTICAL DEVELOPMENT

Before the days of mass literacy, medicine was more art than science, and people recognized a pharmacy by the four traditional colored bottles that represent earth, fire, air, and water. Medicine has come a long way since the days of the apothecary with its impressive collection of powders and bottles; drugs today are highly regulated and must comply with standards set by the ., Europe, Japan, and other countries. A drug must be shown to be efficacious and meet rigorous standards of purity, composition, and potency before being approved for use in the patient populatio. | Iliialftical ĩichiiqoes for Diapharnatoitical Development Copyright 2005 by Marcel Dekker. Analytical ĩEChnỉquES for Biopharmaceutical Development Edited by Roberto RodrjguezDiaz BynavanfeoMnsies Berkeley California . TioiWehr Bio-Bad laboratories Hercules California Stephen Tuck . OynavaK Technologies Berkeley California Taylor . Francis . J Taylor . Francis Group Boca Raton London New York Singapore Copyright 2005 by Marcel Dekker. Although great care has been taken to provide accurate and current information neither the author s nor the publisher nor anyone else associated with this publication shall be liable for any loss damage or liability directly or indirectly caused or alleged to be caused by this book. The material contained herein is not intended to provide specific advice or recommendations for any specific situation. Trademark notice Product or corporate names may be trademarks or registered trademarks and are used only for identification and explanation without intent to infringe. Library of Congress Cataloging-in-Publication Data Analytical techniques for biopharmaceutical development Tim Wehr Roberto Rodriguez-Diaz Stephen Tuck editors. p. cm. Includes bibliographical references and index. ISBN 0-8247-2667-7 alk. paper 1. Protein drugs--Analysis--Laboratory manuals. DNLM 1. Pharmaceutical Preparations--analysis--Laboratory Manuals. 2. Biopharmaceutics--methods--Laboratory Manuals. 3. Chromatography--methods--Laboratory Manuals. 4. Electrophoresis--methods--Laboratory Manuals. 5. Spectrum Analysis--methods--Laboratory Manuals. QV 25 A5338 2005 I. Wehr Tim. II. Rodríguez-Díaz Roberto. III. Tuck Stephen Stephen F. 2005 615 .7--dc22 2004058292 ISBN 0-8247-0706-0 This book is printed on acid-free paper. Headquarters Marcel Dekker 270 Madison Avenue New York NY 10016 . tel 212-696-9000 fax 212-685-4540 World Wide Web http Copyright 2005 by Marcel Dekker. All Rights Reserved. Neither this book nor any part may be .

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