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Document Type: | Book |
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All Authors / Contributors: |
Jens Thurø Carstensen; Christopher Thomas Rhodes |
ISBN: | 0824703766 9780824703769 |
OCLC Number: | 474755587 |
Description: | vii, 773 s. : illustrations |
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. |
Series Title: | Drugs and the pharmaceutical sciences, vol. 107 |
Responsibility: | Jens T. Carstensen, C.T. Rhodes |
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