Bioanalytical part is the most important step in clinical pharmacokinetic studies. Employed bioanalytical methodology is one of the key success factors for the studies concerned.
Measurement of concentrations of drug substances in biological media can be performed during the following types of studies:
- bioequivalence studies;
- phase I pharmacokinetic studies;
- additional pharmacokinetic part in phase II-IV studies.
The bioequivalence studies and phase I studies are primary scope of work performed by the bioanalytical laboratory Quinta-Analytica Yaroslavl. Nevertheless, considering the versatility of methodological approaches applied in different types of pharmacokinetic studies, the laboratory is ready for cooperation in the field of other aspects of research work.
The services of Quinta-Analytica Yaroslavl LLC performed within the scope of bioanalytical part of pharmacokinetic studies include the following:
- analytical method development: selection of appropriate conditions for sample preparation, chromatographic procedure, and mass-spectrometric detection, preliminary evaluation of analyte stability;
- full validation of analytical procedure regarding main parameters provided by current regulatory documents;
- partial validation of analytical procedure within the scope of specific project;
- preparation of validation report according to the established template pursuant to current regulatory requirements;
- development of laboratory manual for handling of blood samples in clinical center;
- analysis of samples obtained during the clinical part of the study with 5-10% incurred samples reanalysis, (ISR);
- preparation of analytical report with the results of measurement of analytes concentration with data enclosed for all analytical batches (calibrations, quality control samples, compliance with acceptance criteria, and reanalysis data) and individual chromatograms;
- calculation of pharmacokinetic parameters and statistical analysis of the data obtained with subsequent preparation of pharmacokinetic and statistical report.