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Drug stability : principles and practices / edited by C.T. Rhodes, Jens T. Carstensen.

Contributor(s): Material type: TextSeries: Drugs and the pharmaceutical sciencesPublication details: New York : Marcel Dekker, 2000Edition: 3rd ed., rev. and expandedDescription: Vol.107, vii, 773 p.: ill. 26 cmSubject(s): NLM classification:
  • QV 754
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-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).
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Item type Current library Home library Call number Status Barcode
Books Dow International Medical College Dow International Medical College QV 754 .D78 2000 (Browse shelf(Opens below)) Available 00001784

Rev. ed. of: Drug stability / Jens T. Carstensen. 2nd ed., rev. and expanded. 1995.

Includes bibliographical references (p. 99-100) and index.

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).

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