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EGE UNIVERSITY

Research and Application Center of Drug Development and Pharmocokinetics

Statistical Methods

Determination of Sample Size

The primary activity of the study is performed in the SAS program based on the parameters.

Data Management and Statistical Methods for Determination of Bioequivalence

Planning the data management process in the light of national and international standards in bioequivalence studies; to determine the sample size in the bioequivalence study and to gain the basic concepts related to statistical evaluations used; This course covers the interpretation of the sample application results to be performed in SAS / EXCEL programs and the presentation of the results of statistical evaluation of bioequivalence studies.

Statistical Evaluation of Clinical Research and Bioengineering Study

Statistical evaluations are carried out in accordance with the Analiz Statistical Analysis Plan.. SAS is used in the evaluation of clinical research data, SAS and WinNonlin are used together in the evaluation of bioequivalence study data.

Preparation of Statistical Results Report

Statistical evaluation results are presented in ”Statistical Result Report.. The results of statistical analyzes are supported by appropriate tables / graphs. The tables / graphics are generated directly from the database via the SAS program.