TY  - BOOK
AU  - Carstensen, Jens Thur??,
AU  - Rhodes, Christopher T.,
TI  - Drug stability: principles and practices 
T2  - Drugs and the pharmaceutical sciences 
PY  - 2000///
CY  - New York
PB  - Marcel Dekker
KW  - Drug Stability
N1  - 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)
ER  -