CombiStats is a software application developed by the EDQM to perform calculations as described in European Pharmacopoeia General Chapter 5.3. Statistical analysis of results of biological assays and tests.
CombiStats Online was released on 4 July 2024. This brand new version offers a flexible licence management system, a dedicated workspace, a modern user-friendly interface and a large set of statistical models and options.
This training course demonstrates the main functionalities and new features of this latest release across 4 modules:
- Module 1: Introduction to the online application
This module begins with an overview of CombiStats Online. Learn about the new ordering process, how to activate your workspace, how to create and manage accounts. The creation and management of assays and templates (.epax and .epmx files) are then explored, which covers the protection, sharing and import/export of files. This is followed by an item on data entry, including the Show design option and the audit trail (available in the analysis report). Tips for batch creating .epax files are also shared, and the demonstrations concludes with an overview of the documentation (FAQs, user guide, privacy and security notices). - Module 2: Assays based on quantal response
This module begins with a presentation of the 4-parameter logistic regression model used to analyse quantal (e.g. pass/fail) data. This is followed by examples of data entry in the data tables or using the Show design option (aggregated data vs individual data) and an overview of the various analysis options and tables of results and graphical representations (e.g. ED50, potency estimates, ANOVA, plot of residuals). - Module 3: Assays based on quantitative response
This module gives an overview of different regression models used to analyse quantitative data (slope-ratio, parallel lines including subset analysis, 4/5-parameter logistic and 3-parameter exponential models). The various analysis options available for each model are explained, and the tables of results and graphical representations (e.g. potency estimates, ANOVA, plot of residuals) are also covered. - Module 4: Single-dose assays, combination of assay results
This module begins with a presentation of the limit test (the Wilcoxon-Mann-Whitney test) performed by CombiStats on single-dose assays. The examples studied addresses in particular how to correctly interpret the p-value of the test. In the second part of this module the fundamentals of the 3 combination approaches are presented, followed by examples of combining assay files (.epax). Finally, you learn about the available options and calculated results in combined files (.epcx).
Target audience
These PDF presentations are of interest to professionals from the pharmaceutical industry, regulatory agencies and academic institutions who are responsible for analysing and interpreting assay data using the new CombiStats Online application.
Download the presentations
- Module 1: Introduction to the online application
- Module 2: Assays based on quantal response
- Module 3: Assays based on quantitative response
- Module 4: Single-dose assays, combination of assay results
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