Dear Sir or Madame,
Our PLA 3.0 Software supports the analysis of 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-Logistics, 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.
In quantitative response assays both parallel-line assays and parallel-logistic assays (3–, 4– and 5-parameter sigmoidal functions) are implemented. Transformation functions for the response values are available for all models to reduce heteroscedasticity. The curve fitting of PLA 3.0 has been extensively optimized to provide high-quality curve fits, since bioassays tend to be very sensitive to the slightest deviations.
Sophisticated Suitability Test System
Testing can be done either by difference/hypothesis testing, as described in the European Pharmacopoeia, or by similarity/equivalence testing, which was introduced by the US Pharmacopeia chapters <111>, <1032>, <1033> and <1034>. The test system of PLA 3.0 is very flexible and lets you perform a number of different tests, which you can configure exactly according to your needs.
Flexible Assay Setup
The assay setup in PLA 3.0 is very flexible. You can setup any assay system with a free number of test or control samples and control lines as well as free numbers of replicates and dilution steps. Symmetric and asymmetric assay setups are supported. When used in combination with the template system of PLA, any assay configuration can be set up in a GxP compliant way.
PLA 3.0 supports four optional outlier detection methods: Dixon Test, Grubb’s Test, Studentized Residual and a test based on the standard deviation of the treatments.
For more information please visit: www.bioassay.de