Methods and systems for determining lot consistency
First Claim
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1. A method for determining lot consistency between a plurality of lots, each of the plurality of lots being associated with each of a plurality of analytes, the method comprising:
- receiving level data elements, each one of the level data elements corresponding to one of the plurality of lots and one of the plurality of analytes;
calculating, using a computer and the following equation, a plurality of test statistics, each one of the plurality of test statistics respectively corresponding to each one of the plurality of analytes,
Zmin=min{(δ
−
|Dij|)/seij},where Dij comprises a difference between two of the level data elements for an ith lot and a jth lot for a given one of the plurality of analytes, seij comprises a standard error of the difference, and δ
comprises an equivalence margin; and
determining that the plurality of lots are consistent when each of the plurality of test statistics exceeds a predetermined value.
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Abstract
This invention provides methods for determining lot consistency between a plurality of lots, systems for determining lot consistency between a plurality of lots, and computer-readable media which store a set of instructions which when executed performs a method for determining lot consistency between a plurality of lots.
10 Citations
32 Claims
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1. A method for determining lot consistency between a plurality of lots, each of the plurality of lots being associated with each of a plurality of analytes, the method comprising:
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receiving level data elements, each one of the level data elements corresponding to one of the plurality of lots and one of the plurality of analytes;
calculating, using a computer and the following equation, a plurality of test statistics, each one of the plurality of test statistics respectively corresponding to each one of the plurality of analytes,
Zmin=min{(δ
−
|Dij|)/seij},where Dij comprises a difference between two of the level data elements for an ith lot and a jth lot for a given one of the plurality of analytes, seij comprises a standard error of the difference, and δ
comprises an equivalence margin; and
determining that the plurality of lots are consistent when each of the plurality of test statistics exceeds a predetermined value. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method for determining lot consistency between a plurality of lots, each of the plurality of lots being associated with each of a plurality of analytes, the method comprising:
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receiving level data elements, each one of the level data elements corresponding to one of the plurality of lots and one of the plurality of analytes;
calculating, using the following equation, a plurality of test statistics, each one of the plurality of test statistics respectively corresponding to each one of the plurality of analytes,
Zmin=min{(δ
−
|Dij|)/seij},where Dij comprises a difference between two of the level data elements for an ith lot and a jth lot for a given one of the plurality of analytes, seij comprises a standard error of the difference, and δ
comprises an equivalence margin; and
determining that the plurality of lots are consistent when each of the plurality of test statistics exceeds a predetermined value.
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12. A system for determining lot consistency between a plurality of lots, each of the plurality of lots being associated with each of a plurality of analytes, the system comprising
a memory storage for maintaining a database and a processing unit coupled to the memory storage, wherein the processing unit is operative to: -
receive level data elements, each one of the level data elements corresponding to one of the plurality of lots and one of the plurality of analytes; and
calculating, using a computer and the following equation, a plurality of test statistics, each one of the plurality of test statistics respectively corresponding to each one of the plurality of analytes,
Zmin=min{(δ
−
|Dij|)/seij},where Dij comprises a difference between two of the level data elements for an ith lot and a jth lot for a given one of the plurality of analytes, seij comprises a standard error of the difference, and δ
comprises an equivalence margin, and determining that the plurality of lots are consistent when each of the plurality of test statistics exceeds a predetermined value. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A computer-readable medium which stores a set of instructions which when executed performs a method for determining lot consistency between a plurality of lots, each of the plurality of lots being associated with each of a plurality of analytes, the method executed by the set of instructions comprising:
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receiving level data elements, each one of the level data elements corresponding to one of the plurality of lots and one of the plurality of analytes; and
calculating, using a computer and the following equation, a plurality of test statistics, each one of the plurality of test statistics respectively corresponding to each one of the plurality of analytes,
Zmin=min{(δ
−
|Dij|)/seij},where Dij comprises a difference between two of the level data elements for an ith lot and a jth lot for a given one of the plurality of analytes, seij comprises a standard error of the difference, and δ
comprises an equivalence margin, and determining that the plurality of lots are consistent when each of the plurality of test statistics exceeds a predetermined value. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. A method for determining lot consistency between a plurality of lots, each of the plurality of lots being associated with each of a plurality of analytes, the method comprising:
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manufacturing the lots and taking samples from the lots, analyzing the analytes in the samples, and generating level data elements from the analyses, wherein each one of the level data elements corresponds to one of the plurality of lots and one of the plurality of analytes;
calculating, using a computer and the following equation, a plurality of test statistics, each one of the plurality of test statistics respectively corresponding to each one of the plurality of analytes,
Zmin=min{(δ
−
|Dij|)/seij},where Dij comprises a difference between two of the level data elements for an ith lot and a jth lot for a given one of the plurality of analytes, seij comprises a standard error of the difference, and δ
comprises an equivalence margin; and
determining whether each of the plurality of test statistics exceeds a predetermined value and thus the plurality of lots are consistent;
and, based on said consistency determination, determining whether to use and/or to discard each of the lots, and/or to adjust the manufacturing process.
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Specification