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Biological Assays
for potency dilution assays, combination of assay results, equivalence…
Biological Assay Simulation
simulation of quantitative response assays based on existing assay…
Control Charts
for statistical process control. Monitor and analyze PLA and other…
Dichotomous Assays
analysis of relative potency assays based on a binary outcome (quantal…
Dose-Response Analysis
for calibration curves, dose interpolation (e.g. ELISA), equivalence…
Microbial Assays for Antibiotics
cylinder-plate and turbidimetric methods according to USP <81> and…
The PLA 3.0.6 software supports the analysis of all types of biological assays and provides a range of biostatistical methods for immunoassays, ELISA, and more. Our PLA 3.0 all-in-one software bundle provides the Biological Assay Package, Control Chart Package, Dichotomous Assay Package, Dose-Response Analysis Package, Microbial Assays for Antibiotics Package and a fully compliant platform.
The established and well known Biological Assay Package supports 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.
The Control Chart Package 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.
The Dichotomous Assay Package provides an update of the dichotomous assay document type. This document type allows you to 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.
The Dose-Response Analysis Package 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.
The Microbial Assays for Antibiotics Package 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.
PLA 3.0.6 is fully compliant with GAMP and 21 CFR Part 11. Our PLA software is the most commonly used software for biostatistical analysis in highly regulated pharmaceutical and biotech industries.
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