Data analysis

Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to assay workflows and statistical process control.

The following figure highlights the data analysis capabilities of PLA 3.0:

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 and create a document of the respective type. For details on how to activate add-ons, see the Activate add-ons topic.

Analytical methods

Design potency assays, cylinder-plate and turbidimetric assays. Set up interpolation analysis, curve comparisons, and more. The following table illustrates which add-on offers which analytical method:


Which method do you want to apply?	Which add-on do you need?
Curve comparisons	Dose-Response Analysis Package
Cylinder plate assays (USP <81> and JP 4.02)	Microbial Assays for Antibiotics Package
Quantal response potency assay (dichotomous potency assay)	Dichotomous Assay Package
ECx calculation	Dose-Response Analysis Package
Interpolation analysis	Dose-Response Analysis Package
bioMérieux endotoxin detection assays	bioMérieux Endotoxin Detection Assay Package
Linearity-of-dilution assessment	Dose-Response Analysis Package
Parallel-line potency assay	Biological Assay Package
Parallel logistic potency assay	Biological Assay Package
Slope-ratio potency assay	Biological Assay Package
Spike-and-recovery analysis	Dose-Response Analysis Package
Turbidimetric assay	Microbial Assays for Antibiotics Package

Supported models

PLA 3.0 includes a broad range of regression models. Each model is available through one or more document types.

The following models are available:

Linear model
2-parameter logistic model
3-parameter logistic model
4-parameter logistic model (with and without control line)
5-parameter logistic model
Hill equation

Linear model

The following document types support the linear regression model:


Document type	Description	Details
bioMérieux endotoxin detection assay	Interpolation analysis with a specialized handling for low signal samples, especially designed for endotoxin impurity assays.	For details, see: Linear model
Cylinder plate assay (JP 4.02)	Simple 2x2 model for cylinder plate assays according to JP 4.02.	For details, see: Cylinder plate assays (JP 4.02)
Cylinder plate assay (USP <81>)	Interpolation analysis with data processing steps specific to USP <81>.	For details, see: Cylinder plate assays (USP <81>)
Dichotomous assay	Generalized linear model for parallel-line potency assays using quantal (count) data with a probit or logit link function.	For details, see: Regression model
Dose-response analysis	Curve comparisons and interpolation analysis.	For details, see: Curve comparisons Interpolation on calibration curves Linear model
Quantitative response assay	Parallel-line potency assays.	For details, see: Parallel-line potency assays Linear parallel-line
Turbidimetric assay (USP <81>/JP 4.02)	Interpolation analysis with data processing steps specific to USP <81> and JP 4.02.	For details, see: Turbidimetric assays (USP <81>/JP 4.02)

2-parameter logistic model

The following document type supports the 2-parameter logistic regression model:


Document type	Description	Details
Dose-response analysis	Curve comparisons and interpolation analysis.	For details, see: 2-parameter logistic fit model with fixed asymptotes

3-parameter logistic model

Fixes one of the asymptotes of the 4-parameter logistic model either through manual input or a control line.

The following document types support the 3-parameter logistic regression model:


Document type	Description	Details
Quantitative response assay	Parallel-logistic potency assays.	For details, see: 3-parameter logistic fit with fixed upper asymptote 3-parameter logistic fit with fixed lower asymptote
Dose-response analysis	Curve comparison and interpolation analysis.	For details, see 3-parameter logistic fit model with fixed upper asymptote 3-parameter logistic fit model with fixed lower asymptote

4-parameter logistic model

The following document types support the 4-parameter logistic regression model:


Document type	Description	Details
bioMérieux endotoxin detection assay	Interpolation analysis with a specialized handling for low signal samples, especially designed for endotoxin impurity assays. Uses weighting.	For details, see: 4-parameter logistic model
Dose-response analysis	Curve comparison and interpolation analysis.	For details, see 4-parameter logistic fit model
Quantitative response assay	Parallel-logistic potency assays. Supports the 4-parameter logistic model with and without control line.	For details, see: Parallel-logistic potency assays 4-parameter logistic fit

5-parameter logistic model

Extends the 4-parameter logistic model by including a parameter that controls model asymmetry.

The following document types support the 5-parameter logistic regression model:


Document type	Description	Details
Quantitative response assay	Parallel-logistic potency assays.	For details, see: 5-parameter logistic fit
Dose-response analysis	Curve comparison and interpolation analysis.	For details, see: 5-parameter logistic fit model

Hill equation

The following document type supports the Hill equation regression model:


Document type	Description	Details
Dose-response analysis	Curve comparisons and interpolation analysis.	For details, see: Hill equation

Suitability testing

Suitability testing ensures that assay results meet predefined performance criteria, confirming that the method is appropriate for its intended use. See the following table for details on the types of test available for the respective document type:


Document type	Details	Available in add-on
bioMérieux endotoxin detection assay	Test system	bioMérieux Endotoxin Detection Assay Package
Cylinder plate assay (JP 4.02)	Test system	Microbial Assays for Antibiotics Package
Cylinder plate assay (USP <81>)	Test system	Microbial Assays for Antibiotics Package
Combination of assay results	Suitability testing	Biological Assay Package
Combination of microbial assays	Test system	Microbial Assays for Antibiotics Package
Dichotomous assay	Suitability testing	Dichotomous Assay Package
Dose-response analysis	Suitability tests	Dose-Response Analysis Package
Quantitative response assay	Suitability testing	Biological Assay Package
Turbidimetric assay (USP <81>/JP 4.02)	Test system	Microbial Assays for Antibiotics Package

Comprehensive analysis

Calculate combined potency values and develop acceptance criteria based on historic assay data. The following data analysis add-ons offer comprehensive analysis capabilities:


Add-on	Capability
Biological Assay Package	The Combination of assay results document type of this add-on lets you 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>.
Biological Assay Package Dose-Response Analysis Package	Both add-ons offer 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 concept of PLA 3.0 to aggregate directly from the independent assays without manual input.
Microbial Assays for Antibiotics Package	The Combination of microbial assays document type of this add-on lets you aggregate data of assay documents, apply confidence limits, check for outliers, perform combination of assays calculations, and define statistical tests.

Assay workflows

Set up control documents to organize assay runs and successive analysis. The following data analysis add-on supports you in setting up assay workflows:


Add-on	Capability
Biological Assay Package	Use the Basic bioassay protocol document type of this add-on 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.

Statistical process control

Control, visualize, and monitor your analytical methods through control charts. The following data analysis add-on supports you in performing statistical process control:


Add-on	Capability
Control Chart Package	Use the Control chart document type of this add-on 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.