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Acta Pharmaceutica Sinica. 2021, (02) Core

Value assignment study on bioactivity of monoclonal antibody working reference standardChinese Full Text

YU Chuan-fei;LIU Chun-yu;WANG Lan;National Institutes for Food and Drug Control;

Abstract: The bioactivity of a working reference standard was determined by replicate bioassays with calibration against a primary reference standard. In this study the number of bioassay replicates needed for calibration first was calculated theoretically, and if the mean value of the experimental bioassay replicates fell within the predefined bioactivity level the bioactivity of the working reference was defined as 100%. Our results showed that when the total intermediate precision of the bioassay metho... More
Keywords：

primary reference standard; secondary reference standard; working reference standard; monoclonal antibody; bioactivity assignment;

  • DOI：

    10.16438/j.0513-4870.2020-1437

  • Series：

    (E) Medicine ＆ Public Health

  • Subject：

    Pharmaceutics

  • Classification Code：

    R917

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