Online application for the Statistical Analysis of Biological Dilution Assay Results or Potency Assay Results

The application was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia. The following models are included:

• Linear regression models for quantitative results: parallel line and slope ratio analysis models,
• Sigmoid models for quantitative results: 4- and 5-parameter logistic regression models,
• 4-parameter logistic regression model for quantal (pass/fail) results, including several data transformations (e.g. probit, logit) and effective doses calculation,
• Analysis of single-dose assays using the Wilcoxon-Mann-Whitney test.

CombiStats is intended for use by persons who perform the analysis of assay data but whose primary training is not in statistics. In support, the main statistical aspects of such analysis are available in the documentation.

The application may be used in any situation where the analysis of data from dilution assays is required including for use in the context of monographs of the European Pharmacopoeia.