Methods and systems for determining lot consistency

Details Methods and systems for determining lot consistency Methods and systems for determining lot consistency

G - Physics

01

N

G01N 33/15 (2006.01) G06F 17/18 (2006.01)

Patent

CA 2533913

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.

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