Drug stability :  principles and practices / 
edited by C.T. Rhodes, Jens T. Carstensen. 
 - 3rd ed., rev. and expanded. 
 - New York :  Marcel Dekker,  2000 
 - Vol.107, vii, 773 p.:  ill.   26 cm. 
 - Drugs and the pharmaceutical sciences  .
<br/><br/> Rev. ed. of: Drug stability / Jens T. Carstensen. 2nd ed., rev. and expanded. 1995. 
<br/><br/>Includes bibliographical references (p. 99-100) and index. 
<br/><br/>Introductory overview -- Solution kinetics -- Kinetic pH profiles -- Oxidation in solution -- Catalysis, complexation, and photolysis -- Solid state stability -- Interactions of moisture with solids -- Physical characteristics of solids -- Performulation -- Physical testing -- Development and validation of HPLC stability-indicationg 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 computerization of stability data -- Stability of polypeptides and proteins -- Regulatory aspects of stability testing in Europe -- Regulatory and scientific aspects of stability testing: present and possible future trends -- Appn.: Guidance for industry: stability testing of drug substances and drug products (draft). 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Drug Stability
<br/><br/><label>National Library of Medicine Call No.: </label>QV 754  / .D78 2000