Cover Story

Curve Fitting, Sophisticated Suitability Test System, Flexible Assay Setup and Outlier Detection

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.

Curve Fitting

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 by difference/hypothesis testing, as described in the European Pharmacopoeia and by similarity/equivalence testing, which was introduced by the updates US Pharmacopoeia chapters on biological assays published in 2012. 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

You can setup any assay system with a free number of test or control samples and control lines (e.g. positive control, negative control) 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.

Outlier Detection

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 about PLA 3.0, please click here.

Best regards
Mathias von Gellhorn
Marketing Manager

Stegmann Systems GmbH, Raiffeisenstr. 2, 63110 Rodgau, Germany
Phone: +49 (6106) 77010-0, Fax: +49 (6106) 77010-190

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