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Stability Assessment and Formulation Characterization
Albert H.L. Chow1; Henry H.Y. Tong2; Ying Zheng3
2007
Source PublicationHandbook of Pharmaceutical Biotechnology
Author of SourceShayne Gad
Publication PlaceHoboken, New Jersey
PublisherJohn Wiley & Sons, Inc.
Pages371-416
Other Abstract

A drug needs to be formulated in a safe, consistent, and stable dosage form with proven clinical efficacy before it can be approved for specific therapeutic indications by drug regulatory authorities. Depending on the modes of chemical degradation or physical denaturation, a wide variety of formulation excipients or additives, including buffers, antioxidants, sugars, and polysaccharides, can be used to preserve the structural integrity and biological activity of such vulnerable macromolecules. This article focuses on the stability problems of biopharmaceuticals and their assessment as well as the formulation approaches that can be used to circumvent these problems.

DOIhttp://www.doi.org/10.1002/0470117117
Language英语
ISBN9780471213864
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Document TypeBook chapter
专题Institute of Chinese Medical Sciences
Affiliation1.The Chinese University of Hong Kong, Shatin, N.T., Hong Kong, China
2.Macao Polytechnic Institute, Macao, China
3.University of Macao, Macao, China
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Albert H.L. Chow,Henry H.Y. Tong,Ying Zheng. Stability Assessment and Formulation Characterization. Hoboken, New Jersey:John Wiley & Sons, Inc.,2007:371-416.
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