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国家药品标准物质是我国药品质量评价的标尺,生物检测用国家标准物质是国家药品标准物质中非常重要的一类。由于生物制品质量评价常采用生物学方法的有效性指标进行检测,而这些方法一般变异性相对较大,因此,生物检测用标准物质(简称生物标准物质)作为生物制品生产检定中必不可少的重要组成部分,在生物制品质量控制和效力评估中发挥着重要的作用[1]。我院作为国家法定的药品、医疗器械标准物质提供单位,负责药品、医疗器械国
The national drug standard substance is the standard of drug quality evaluation in our country. The national standard substance for biological test is a very important category in the national drug standard substance. Because biological products quality assessment often use biological methods to detect the effectiveness of indicators, and these methods generally have relatively large variability, therefore, the biological testing of reference materials (referred to as biological standards) as a biological product testing is essential An important part of biological products in the quality control and effectiveness evaluation plays an important role [1]. Our hospital as a national statutory drug, medical equipment standard material provider, is responsible for medicine, medical equipment country