PLA 3.0 – Software for Biostatistical Analysis: PLA 3.0 capabilities

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Analyze Biological Assays

Analyze all types of biological assays according to European Pharmacopoeia, Chapter 5.3 and US Pharmacopeia <111>, <1032>, <1033>, <1034>: Quantitative response assays (parallel-line, parallel-logistic, slope-ratio). PLA 3.0 also supports all different weighting methods for combination calculations and the automatic data aggregation of independent assay data. Additional document types are available for equivalence margin development, control charts and a Basic bioassay protocol.

Analyze quantal response assays

Analyze biological dilution assays based on a binary (quantal) outcome. Fit probit and logit models to the probability distributions of your sample data and compare them to the reference standard.

Analyze the endotoxin concentration in a substance

Analyze the endotoxin detection assays of the bioMérieux assay kits EndoLISA® and ENDOZYME® II GO. Simplify your reporting process by effortlessly creating professional PDF reports while taking advantage of our data export capabilities for external data processing.

Analyze the dose-response relationship

PLA 3.0 provides biostatistical methods, equivalence testing and equivalence margin development for calibration curves, enhanced data processing, and subgroup analysis. The methods support linearity-of-dilution assessment, spike-and-recovery analysis, effective-concentration calculation, and curve comparisons. Document reports and dashboards add to its value and usability.

Data analysis

PLA 3.0 supports a wide variety of methods for biostatistical analysis.

Determine the potency of antibiotics

PLA 3.0 covers potency estimation of cylinder-plate assays and turbidimetric assays as described in the U.S. Pharmacopeia <81> and Japanese Pharmacopoeia Chapter 4.02 to determine the potency of antibiotics. Document the assay setup and the used materials, calculate the potency, and create a report summarizing your assay and it's results.

Develop Equivalence margins

Individually plot test samples and develop acceptance criteria based on historic data.

Generate reportable values from quantitative response assays

The PLA 3.0 'Basic bioassay protocol' provides a general workflow to produce reportable values from Quantitative response assays.

Import your data

PLA 3.0 supports through its extensibility (add-ons) the plate reader control and its direct import of data, as well as the import of Microsoft Excel® formats and all common text formats. Of course, PLA 3.0 offers you configuration profiles to conveniently import your data.

Perform combination calculations

PLA 3.0 supports you with all weighting methods for combination calculations, automatic data aggregation of independent assay data and the grouping of combination calculations

Perform compliance-safe adjustments on assay documents

Perform compliance-safe adjustments on assay documents and compare the effects of different analytical settings. You can also split assays by their test samples for an individual analysis.

Perform a curve comparisons

Individually plot test samples and use the document dashboard or one of the document reports to compare the resulting curves. PLA 3.0 supports various analytical (regression) models.

Perform a Linearity-of-dilution assessment

Determine the precision of your method at different levels of dilution.

Perform a sophisticated statistical process control

PLA 3.0 allows sophisticated statistical process control (for example, by plotting Shewhart I-Charts as recommended in the USP <1010>). Out-of-control data can be detected by defining control limits and control rules. A status display provides valuable feedback about the impact of a rule violation. Optional features include events to mark changes in the process, sidecharts to contain basic statistics in a box plot, the creation of subcharts for a specific range, and confidence intervals. Moreover, a secondary column can be used to factorize the data series.

Simulate Biological Assays

Simulation of quantitative response assays based on existing assay data and manual definitions of assay characteristics. Improve your insight into the behavior of your methods.

Use the traceability and audit trail

PLA 3.0 records every change anyone makes to a document in the audit trail of the software. The audit trail can be searched and exported.

Use the validation (IQ, OQ, PQ)

PLA 3.0 runs a fully automated Installation Qualification (IQ) and Operational Qualification (OQ), and a semi-automated (with your own data) Performance Qualification (PQ).

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