Previous editions cataloged under: Cartensen, Jens Thurø, 1926- Drug stability
یادداشتهای مربوط به کتابنامه ، واژه نامه و نمایه های داخل اثر
متن يادداشت
Includes bibliographical references and indexes
یادداشتهای مربوط به مندرجات
متن يادداشت
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)