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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Clinical Trials and Bioanalyses

 

Pharmacokinetics and statistical evaluation

Specialized software is used for pharmacokinetic and statistical evaluation of study results:

  • SAS® (SAS Institute Inc.,www.sas.com)
  • WinNonlin® Professional (Pharsight Corporation, www.pharsight.com)

Our services:

  • Graphs of pharmacokinetic profiles (average, individual, overlay graph of all subjects with the same treatment etc.)
  • Calculation of pharmacokinetic parameters (non-compartmental model):
    • single dose: AUC0-t, AUC0-¥, Cmax, Tmax, Kel, T1/2
    • steady-state: AUCτ, Cmax,ss, Cmin,ss, Tmax,ss , Fluctuation
  • Statistical evaluation of bioequivalence – average bioequivalence for parallel design, 2x2 crossover design, replicative 2-treatment 4-period design...
  • Analysis of variance ANOVA – mixed model (log-transformed data, untransformed data), LS-means, residual variability, within subject variability...
  • Hypothesis testing (Schuirmann)
  • Power of ANOVA – multiplicative model
  • Non-parametric ANOVA
  • Pharmacokinetic parameters calculation according to client requirements, e.g. Langmuir’s constants for in-vitro bioequivalence evaluation
  • Calculation of absolute or relative bioavailability
  • Pharmacokinetic / toxicokinetic evaluation (accumulation, dose-proportionality...)
  • Descriptive statistics, confidence interval, testing for outlying values
  • Significance of tested effects – influence of treatment, food, sex, age...
  • Compartmental modeling (WinNonlin)
  • and other calculations according to your requirements.