Head of Team
tel. +48 22 568 24 28
The Pharmacokinetics Team has been carrying out studies of the equivalence (since 1883) and bioavailability of medicinal products. Since 2003, the team has been working in accordance with the principles of Good Laboratory Practice (Certificate No. 25/2020/GLP). As part of cooperation with domestic and foreign pharmaceutical companies and clinical institutions, the team performed over 400 methods validation and pharmacokinetic studies.
The scope of activity:
- Study design
- Development or adaptation of a bioanalytical method for the determination of drug substances and / or metabolites in biological material
- Bioanalytical method validation (EMA)
- Pharmacokinetic calculations (WinNonlin)
- Study documentation (CTD)
- Expert opinion
- Pharmacokinetic study management (incl. the clinical part)
- Grant proposal preparation
- Quattro PREMIER tandem mass spectrometer (Waters) connected to HPLC (LC / MS / MS)
- LCMS-2010 mass spectrometer (Shimadzu) combined with HPLC (LC / MS)
- UHPLC and HPLC with UV-VIS, electrochemical and fluorimetric detectors
- UPLC Acquity with TUV detector (Waters)
- Hudson Robotics, Inc., SOLO Version 8.37, automated sample preparation for analysis.
- Free on-line tool for the presentation of Incurred sample reanalysis (ISR) results, prepared in cooperation with the Warsaw University of Technology, available at https://modelvis.shinyapps.io/isrVis/. The tool is presented in the journal Bioanalysis, Vol.9, No.12.
- Free on-line tool to help find the cause of RRI results that do not meet the acceptance criteria, prepared in cooperation with the Warsaw University of Technology: https://modelvis.shinyapps.io/isr3d/.The tool is presented in the journal Bioanalysis, Vol.10, No.3