TY  - BOOK
AU  - Rhodes,Christopher T.
AU  - Carstensen,Jens Thurø
AU  - Carstensen,Jens Thurø
TI  - Drug stability: principles and practices 
T2  - Drugs and the pharmaceutical sciences
SN  - 0824703766 (alk. paper)
AV  - RS424 .C37 2000
U1  - 615.1901 21
PY  - 2000///]
CY  - New York
PB  - Marcel Dekker
KW  - Drug stability
N1  - Previous editions cataloged under: Cartensen, Jens Thurø, 1926- Drug stability; Includes bibliographical references and indexes; 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)
UR  - http://www.loc.gov/catdir/enhancements/fy0647/00031584-d.html
ER  -