Drug stability : principles and practices / edited by Jens T. Carstensen, C.T. Rhodes.
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TextLanguage: English Series: ; | Drugs and the pharmaceutical sciencesPublication details: New York : Marcel Dekker, c2000. Edition: 3rd ed., rev. and expandedDescription: vi, 773 p. : ill. ; 29 cmISBN: 0824703766 (alk. paper); 9780824703769Subject(s): Drug stability | GuidelinesDDC classification: 615.18 LOC classification: RS424 | .C37 2000Online resources: WorldCat details | E-book Fulltext | Item type | Current library | Collection | Call number | Copy number | Status | Date due | Barcode | Item holds |
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Includes bibliographical references and indexes.
TOC Contents: Solution kinetics; kinetic pH profiles; oxidation in solution; catalysis, complexation, and photolysis; solid state stability; interactions of moisture with solids; physical characterisation of solids; preformulation; 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 computerisation of stability data; stability of polypeptides and proteins; regulatory aspects of stability toting in Europe; regulatory and scientific aspects of stability testing - present and possible future trends.
Summary:
Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products. This book gives fundamental theory and practical advice on Read more...
Pharmacy
Saifun Momota
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