CombiStats: What's new in the web application?
CombiStats is the calculation program for the statistical analysis of results of biological assays and tests, according to Chapter 5.3 of the European Pharmacopoeia. The web-application was released on 4 July 2024. This brand-new version of the software offers a:
Flexible license management system
Upon registration using the EDQM Store, a unique licence key (CSID) together with the number of user access requested is sent to the client. The user who takes the role of licence manager can then assigns colleagues. Changes are managed at the client level directly, e.g., the role of licence manager can be passed on another user, users can be revoked and their access assigned to others. The renewal of the licence key can be requested using the EDQM Store.
Dedicated workspace
The licence key activation results in the creation of a dedicated workspace accessible to users using their login and password. Users can create their own folder tree and share folders with users of the workspace and even with external users, under certain conditions. Created CombiStats files can be renamed, moved, protected, deleted and exported locally (and reimported easily). Importantly, the files created using the CombiStats Desktop versions 5.0 to 7.0 can be imported and processed in the web application.
Modern user-interface
The user can navigate between various panels in order to enter data, select Wizard and advanced analysis options, visualise regression analysis plots, or consult the content of the audit trail. Some regression analysis results and the final analysis report can be exported locally as an Excel table and PDF document, respectively.
The application comes with many information instant messages to guide the user through the application. A Help page is also available with links to several notes addressing different aspects of the application.
Large set of statistical models and options
Quantitative results can be analysed using linear parallel line or slope ratio analyses or sigmoid curve models (4- and 5-parameter logistic models). The 4-parameter logistic model used for quantal responses (e.g. pass/fail results) comes with several transformations including Probits and Logits. Single-dose assays are analysed using a limit test.
For the parallel line assay, CombiStats can create subsets of data (doses and results) and report the values of typical validity criteria (e.g. non-linearity, non-parallelism p-values). CombiStats keeps as many doses as possible and display the statistical results of a valid subset that shows the steepest slope (or highest R²).
The assay layout can be displayed to specify of the course of the experiments (at random, by blocks, or as a Latin square design). Blank results can be entered in a separate table and summarised using simple statistics (mean, standard deviation, and coefficient of variation).
Last but not least, the potency results of several assays can be combined. CombiStats reports the averaged potency values and confidence limits for the 3 calculation approaches described in Chapter 5.3.
For more details information about CombiStats and an access to the user manual, security and privacy notices, click here.