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