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Hiroko Shibata1, Taiji Oyama2, Masato Kiyoshi1

  • 1Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan.

概括

本研究引入了一种量化方法,用于使用光谱距离来比较生物类似药和参考产品的质量属性. 这种方法可以对更高阶结构进行客观评估,证实了大多数已批准的生物类似药的相似性.

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