Drug stability: principles and practices
by Carstensen, Jens Thur Rhodes, Christopher T.
Title Statements
- Full title :Drug stability : principles and practices / edited by Jens T. Carstensen, C.T. Rhodes.
Edition Statements
- Publication Date:©2007.
- Edition:3rd ed., rev. and expanded
Publication Statements
- Publisher(s):Informa healthcare
- Place of Publication:New York
- Language:eng
- Publication Date:©2007.
Notes
Reprint. Originally published: New York : Marcel Dekker, 2000.
The Physical Object
- Description:vii, 773 pages : : illustrations.
Edition Identifiers
- ISBN:0824703766, 9780824703769
- oclc:ocn881279198
Table of 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-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 -- Appendix: Guidance for industry : stability testing of drug substances and drug products (draft)
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