Sample size calculation
(number of subjects required for the study)
Development of statistical plans
Statistical analysis of pharmacokinetic data:
- drug concentration versus time curves (mean curves, individual curves for each subject, the total curve for all subjects, etc.)
- calculation of the basic and additional pharmacokinetic parameters by nonkompartmental/kompartmental methods (single dose study and multiple dose study)
- pharmacokinetic modeling
- analysis of variance ANOVA
- evaluation of bioequivalence
- estimation of the absolute/relative bioavailability, etc.
- preparation of reporting documents for statistical data processing
Final Report writting
Study design:
- cross-over
- parallel
- replicate
- two-stage
Development of randomization scheme, which allows to reduce the systematic error associated with the distribution of the subjects into groups in the study
Statistical analysis of the clinical part of the study:
- point estimation
- interval estimation
- comparing data before and after treatment
- evaluation of the significance of differences between groups, etc.
And other services of statistical data processing in accordance with customer wishes