Drug stability : principles and practices / edited by Jens T. Carstensen, C.T. Rhodes.

Contributor(s): Rhodes, Christopher T, 1937- | Carstensen, Jens Thurø, 1926-
Material type: TextTextLanguage: English Series: ; Drugs and the pharmaceutical sciencesPublisher: New York : Marcel Dekker, c2000Edition: 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
Contents:
Table of contents 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: 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...
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Text Text EWU Library
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615.173 PHA 2005 The pharmaceutical regulatory process / 615.173 PHA 2005 The pharmaceutical regulatory process / 615.18 DRU 2000 Drug stability : 615.18 DRU 2000 Drug stability : 615.18 DRU 2000 Drug stability : 615.18 DRU 2000 Drug stability : 615.18 DRU 2000 Drug stability :

Includes bibliographical references and indexes.

Table of contents 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

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