Computer Software for the Statistical Analysis of Biological Dilution Assay Results

CombiStatsTM is a computer program for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia (10th Edition). The following models are included:

  • Parallel line models
  • Slope ratio models
  • Probit models
  • ED50 calculations
  • 4- and 5-parameter logistic curve models
  • Single dose models

And many more of the family of generalized linear models.

CombiStatsTM is intended for use by persons responsible for the analysis of assay data but whose primary training is not in statistics and who have no access to expert statisticians to assist them with the analysis. The software may be used in any situation where the analysis of data from dilution assays is required but it is primarily intended for use in the context of monographs of the European Pharmacopoeia.