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9 Pochaevskaya Str., Rubizhne, Lugansk region

+38 (050) 471-29-38

Statistical analysis

Pharmbiotest provides statistical support of clinical trials (pharmacokinetic studies and bioequivalence studies, dose-proportionality, efficacy, tolerability, safety, etc.):

  • study design:

- cross-over,
- parallel,
- replicate,
- two-stage;

  • sample size calculation (number of subjects required for the study);
  • development of randomization scheme, which allows to reduce the systematic error associated with the distribution of the subjects into groups in 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;

  • 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;

  • preparation of reporting documents for statistical data processing;
  • Final Report writting;
  • and other services of statistical data processing in accordance with customer wishes.


Statistical data processing is conducted in accordance with international standards, state regulatory requirements and standard operating procedures.

Software
WinNonLin (Pharsight Corp., USA)