Quinta-Analytica Yaroslavl LLC performs the following functions in the field of pharmacokinetics and biostatistics:
calculation of pharmacokinetic parameters and statistical assessment of bioequivalence pursuant to current regulatory requirements as part of the studies of all design types that can be used(cross-over two-, three-, and four-step studies, responsive design, parallel group studies, multiple-dose studies) with subsequent preparation of pharmacokinetic and statistical report;
calculation of extended list of pharmacokinetic parameters and pharmacokinetic modeling within the scope of pharmacokinetic part of phase I-IV studies;
planning the bioequivalence studies and phase I-IV studies: calculation of sample size, statistical rationale for study design, calculation of statistical power, development of blood sampling schedule for evaluation of pharmacokinetics, randomization schedules, selection of methods of statistical analysis, development of statistical design;
statistical analysis of efficacy and safety endpoints, preparation of relevant statistical reports.
"Quinta Analytica Yaroslavl" LLC
Bioequivalence studies, phase I clinical trials, validation of bioanalytical techniques, pharmacokinetic calculations, statistical analysis, consulting services