BIOANALYTICAL TESTING

Analytical services for pre-clinical studies up through Phase III, including statistical evaluation.
Comprising experienced experts, our team has completed more than 600 bio-studies for pharmaceutical companies, across Europe, the United States, Asia and Australia.

Overview

Most activities of the Bioanalytical department, which collaborates with the Clinical department of the company, are focused on conducting complete bioequivalence studies (including clinical, analytical, pharmacokinetic and statistical part) as well as the analyses of diagnostic biomarkers.

The Bioanalytical department comprises a team of experienced analysts and laboratory technicians. The laboratories are equipped with nine modern LC/MS/MS devices with triple quadrupoles, six of which being additionally equipped with a 2-channel HPLC system. The capacity of the Bioanalytical department is up to 3,750 analyses of biological samples per day (including calibration and QC samples and depending on the complexity of the analyses).

Development and validation of bioanalytical methods

Bioanalytical methods are developed and validated in accordance with GLP rules and ICH/FDA and EMEA guidelines. So far, over 300 methods have been developed and validated in the company. Please see below for a full list of our bioanalytical methods, and if you don’t find what you’re looking for please contact us.

PK/TK studies on animals

In the area of ​​pre-clinical evaluation of active ingredients in animals, the Bioanalytical department cooperates with partners in the Czech Republic as well as in the world and conducts its own toxicological and pharmacokinetic studies.

During these activities, Quinta provides complete analytical support comprising inspections of the quality of the application forms, analyses of the studied active ingredients and metabolites in the collected biological samples. Quinta also performs the subsequent toxicokinetic and pharmacokinetic evaluations.

Analyses of drugs and their metabolites

Within clinical trials in different phases, the Bioanalytical department cooperates with the Clinical department of Quinta as well as with external clinics in the world that conduct their own PK/PD and BA/BE studies.

The Bioanalytical department provides a complete analytical support from the preparation of protocols, through the development and validation of bioanalytical methods, preparation of the sampling manuals for clinical workplaces, analyses of the studied active ingredients and/or metabolites in the collected biological samples to the pharmacokinetic and statistical evaluation of the studies.

Determination of structure of metabolites

In addition to its own Clinical department in the company, the Bioanalytical department cooperates with many clinics involved in Phase I clinical trials. Highly trained and experienced employees also take part in determining the structure of metabolites and their isolation from biological matrices.

Biostatistic evaluation

We perform calculations of pharmacokinetic parameters and statistical evaluation of the results of studies results using specialized software:

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

Services offered:

  • displaying graphs of pharmacokinetic profiles (mean, individual, overlay of all the subjects for the given type of treatment, etc.)
  • calculation of pharmacokinetic parameters (non-compartmental model)
    • single dose: AUC0-t     , AUC0-¥      , Cmax , Tmax        , λz   , T1/2
    • steady-state: AUCτ   , Cmax,ss           , Cmin,ss           , Tmax,ss           , Fluctuation
  • statistical evaluation of bioequivalence – average bioequivalence (parallel design, 2×2 crossover design, replicative 2-treatment 4-period design, etc.)
  • multi-dimensional ANOVA – mixed model (log-transformed data, un-transformed data), LS-means, residual variability, within subject variability, etc.
  • hypothesis testing (Schuirmann)
  • power of tests (power of ANOVA – multiplicative model)
  • non-parametric tests (non-parametric ANOVA)
  • calculation of other pharmacokinetic parameters according to the requirements of the customer, e.g. Langmuir model (in-vitro bioequivalence),
  • calculation of bioavailability (absolute, relative bioavailability)
  • pharmacokinetic / toxicokinetic evaluation (accumulation, dose-proportionality, etc.)
  • descriptive statistics, confidence interval, outlying value ​​tests
  • statistical significance of the observed influences – influence of the dosage form, diet, sex, age, etc.
  • compartmental modeling (WinNonlin)
  • and other calculations according to the requirements of the customer
Validated Bioanalytical Methods