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Фармбиотест

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Biostatistics

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

  • 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

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

Software: WinNonLin (Pharsight Corp., США)

Please contact our team at contact@pharmbiotest.com.ua to discuss your specific needs and application.

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