Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to statistical process control. PLA 3.0 also provides a set of add-ons that support and supplement data analysis add-ons.
All add-ons come equipped with a set of document types, each of which covers a specific capability. To make use of a capability, activate the respective add-on in your PLA 3.0 database, create a document of the respective type, and start to develop your assays. For details on how to activate add-ons, see the Activate add-ons topic.
Analytical methods
The following table illustrates which add-on provides which analytical method:
| Which method do you want to apply? | Which add-on do you need? |
|---|---|
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Curve comparisons |
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Cylinder plate assays (USP <81> and JP 4.02) |
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Quantal response potency assay (dichotomous potency assay) |
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ECx calculation |
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Interpolation analysis |
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bioMérieux endotoxin detection assays |
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Linearity-of-dilution assessment |
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Parallel-line potency assay |
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Parallel logistic potency assay |
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Slope-ratio potency assay |
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Spike-and-recovery analysis |
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Turbidimetric assay |
Comprehensive analysis
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This add-on provides the Combination of assay results document type that you can use to calculate reportable value for potency from independent assays, using the data aggregation feature of PLA 3.0. This document type supports weighted and unweighted combinations as described in the EP 5.3, USP <111> and USP <1034>.
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Biological Assay Package and Dose-Response Analysis Package
Both add-ons provide the Equivalence margin development document type. Equivalence margin development is a powerful core method of PLA 3.0. Use this document type to calculate up to 69 candidate equivalence margins like difference of parameter estimates, ratios of parameter estimates, and scaled ratios of parameter estimates. Use the data aggregation feature of PLA 3.0 to aggregate directly from the independent assays without manual input.
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Microbial Assays for Antibiotics Package
This add-on provides the Combination of microbial assays document type that you can use to aggregate data of assay documents, apply confidence limits, check for outliers, perform combination of assays calculations, and define statistical tests.
Assay workflows
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This add-on provides the Basic bioassay protocol document type that you can use as control document to set up a typical analytical flow towards reportable values. You use this document type to organize quantitative response assays and the respective combination calculations of assay results.
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Biological Assays Simulation Package
This add-on provides the QRA simulator and QRA collector document types that you can use to create simulations of quantitative response assays.
Statistical process control
The Control Chart Package provides the Control chart document type that you can use to set up sophisticated statistical process control (for example, by plotting Shewhart I-Charts as recommended in the USP <1010>). Use visualization options for intervals, subcharts and sidecharts, and define colors by a secondary characteristic.
Test system
Resources
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Generic Document Types Package
This add-on provides a set of document types that you can use to document general information, that is contact information, notes, appointments, and tasks.
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Measurement Documentation Package
This add-on provides a set of document types that you can use to document different aspects of a measurement, that is, operator, equipment, and substance.
Tools
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Use the Integration Report Package to create reports in additional file formats that are not covered by the standard PLA 3.0 reporting functionality.
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Use the Split Assay Package add-on to split a Quantitative response assay into one-on-one assays.
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Toolkit for Biological Assay Package
Use the Toolkit for Biological Assay Package to modify the analytical settings of larger sets of Quantitative response assays or to split Quantitative response assays.