Stability Assessment and Formulation Characterization
作者： Albert H.L. Chow , Henry H.Y. Tong , Ying Zheng
DOI: 10.1002/9780470571224.PSE301
关键词:
摘要: A drug needs to be formulated in a safe, consistent, and stable dosage form with proven clinical efficacy before it can approved for specific therapeutic indications by regulatory authorities. Depending on the modes of chemical degradation or physical denaturation, wide variety formulation excipients additives, including buffers, antioxidants, sugars, polysaccharides, used preserve structural integrity biological activity such vulnerable macromolecules. This article focuses stability problems biopharmaceuticals their assessment as well approaches that circumvent these problems. Keywords: formulation approaches; clinical efficacy; biological products; therapeutic agents
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