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:

Figure 1. Capabilities of data analysis add-ons in 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

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.