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