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" Drug stability : "


Document Type : BL
Record Number : 587279
Doc. No : b416498
Title & Author : Drug stability : : principles and practices /\ edited by Jens T. Carstensen, C.T. Rhodes
Edition Statement : 3rd ed., rev. and expanded
Publication Statement : New York :: Marcel Dekker,, c2000
Series Statement : Drugs and the pharmaceutical sciences ;; 107
Page. NO : vii, 773 p.:: ill. ;; 26 cm
ISBN : 08247037660842703766 (alk. paper)
Notes : Previous editions cataloged under: Cartensen, Jens Thurø, 1926- Drug stability
Bibliographies/Indexes : Includes bibliographical references and indexes
Contents : 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-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 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)
Subject : Drug stability
Subject : Drug Stability
Dewey Classification : ‭615/.18‬
LC Classification : ‭RS424‬‭.C37 2000‬
Added Entry : Carstensen, Jens Thurø,1926-
: Rhodes, Christopher T.,1937-
: Carstensen, Jens Thurø,1926-
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