To achieve "reportable values" for your assays, you need to perform combination calculations of your independent biological assays. The combination calculation of PLA 3.0 aggregates the data of independent assay runs into a combination calculation.
The European Pharmacopoeia and the US Pharmacopeia describe different methods of combination calculations for independent assay results to obtain reportable values for the potency. PLA supports all different weighting methods for combination calculations. PLA also supports automatic data aggregation of independent assay data.
- Unweighted Combination
- Homogeneously Weighted Combination
- Heterogeneously Weighted Combination according to European Pharmacopoeia, chapter 5.3
- Heterogeneously Weighted Combination according to US Pharmacopeia <111>
- Heterogeneously Weighted Combination according to US Pharmacopeia <1034>
PLA 3.0 also supports grouping of combination calculations.
Example: consider two independent quantitative response assays with two test samples in each assay: Assay 1 contains test samples for Product A and Product B. Assay 2 contains test samples for the same products. In a grouped analysis you will receive two seperate combination calculations. One for Product A as well as one for Product B.
You can set up acceptance tests for the calculation results of the combination calculation.
- Grouped combination calculation of potency results of five independent assays.