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Drug stability : principles and practices / edited by Jens T. Carstensen, C.T. Rhodes. - Third edition, revised and expanded. - vii, 773 pages. : Illustrations ; 26 cm - Drugs and the pharmaceutical sciences ; v. 107. .

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).

ISBN: 0824703766 (alk. paper)

LCCN: 00031584

Subjects--Topical Terms:
Drug stability.

LC Class. No.: RS424 / .C37 2000

Dewey Class. No.: 615.1901 / D