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, 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) and dichotomous assays (quantal response, binary assays). 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 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.