| Abstract [eng] |
When introducing new drugs to the market in pharmaceutical industry, researchers have to solve bioequivalence problem using statistical methods. In some occasions different conclusions about bioequivalence are made from the same data, when using several methods, so the biggest problem is choise of the appropriate method. The main purpose of this work – to develop methodology, models and user – friendly software tools for bioequivalence study research in the virtual environment, which significantly reduced research costs and error amount by selecting appropriate methods and applying them to specific data. In this paper, methodology for applying bioequivalence methods was proposed, which selects the appropriate methods by statistical test application assumption checking and modeling of test power results. Proposed methodology and models were implied on data analysis system SAS basis, by combining JSP technology, SAS/CONNECT module. |
