发明名称 METHODS AND SYSTEMS FOR DETERMINING LOT CONSISTENCY
摘要 A method and system for determining lot consistency, for example, between three or more vaccine lots, is disclosed. Level data elements are received for each of Lots. A test statistic is calculated for each lot using the equation: Zmin=min{(.delta. - ¦D ij¦) /Se ij} where D ij comprises a difference between two of the level data elements for an i th lot and a j th lot, Se ij comprises a standard error of the difference, and .delta. comprises an equivalence margin. The plurality of lots are determined to be consistent when each of the plurality of test statistics exceeds a predetermined value.
申请公布号 CA2533913(A1) 申请公布日期 2006.07.25
申请号 CA20062533913 申请日期 2006.01.24
申请人 SOLVAY PHARMACEUTICALS B.V. 发明人 NAUTA, JOZEF J.P.
分类号 G01N33/15;G06F17/18 主分类号 G01N33/15
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