Drug stability : principles and practices / edited by Jens T. Carstensen, C.T. Rhodes. - 3rd ed., rev. and expanded. - New York : Marcel Dekker, c2000. - vi, 773 p. : ill. ; 29 cm. - . - Drugs and the pharmaceutical sciences. .



Includes bibliographical references and indexes.

Contents: Solution kinetics; kinetic pH profiles; oxidation in solution; catalysis, complexation, and photolysis; solid state stability; interactions of moisture with solids; physical characterisation of solids; preformulation; physical testing; development and validation of HPLC stability-indicating assays; stability testing of clinical trial materials; a rational approach to stability testing and analytical development for NCE, drug substance, and drug products marketed product stability testing; packaging, package evaluation, stability, and shelf-life; industrial stability testing in the United States and computerisation of stability data; stability of polypeptides and proteins; regulatory aspects of stability toting in Europe; regulatory and scientific aspects of stability testing - present and possible future trends. Table of contents

Summary:
Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products. This book gives fundamental theory and practical advice on Read more...



0824703766 (alk. paper) 9780824703769

00031584


Drug stability.

Guidelines.

RS424 / .C37 2000

615.18

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