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EGE UNIVERSITY

Research and Application Center of Drug Development and Pharmocokinetics

Data Management Unit

Data Management and Statistical Methods in Clinical Research

Planning procedures for archiving and archiving clinical research data in accordance with statistical evaluation; determination of statistical methods appropriate to the type of measurement and study design and the sample size associated therewith; preparation of statistical analysis plan within the framework of the study protocol; This standard covers reporting and interpretation of statistical evaluation results.

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.