The core facility will offer an integrated portfolio of Good Laboratory Practice (GLP) certified analytical and bioanalytical services at all stages of the drug development process – from preclinical testing (ADME), through bioequivalence (BE) and pharmacokinetics (PK) to clinical trials (including statistical calculations) to drug registration support. The Bioanalytical Laboratory’s profile includes qualitative and quantitative determination of compounds and their metabolites in biological samples of human or animal origin using high-performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) and immunoassays (ELISA).
- consultation on the clinical trial design, including pharmacokinetic, bioavailability and bioequivalence analyses,
- development and validation of bioanalytical methods for the determination of the drug and/or its metabolite/s in a biological matrix in accordance with the EMA/FDA guidelines, completed with a validation report,
- transfer or cross-validation of bioanalytical methods developed outside the laboratory,
- sample preparation (including post-sampling pre-treatment if necessary),
- sample analysis, completed with an appropriate analytical report,
- pharmacokinetic parameters calculation (for all routes of administration, regardless of the dosing schedule), including specialized statistical calculations (WinNonlin).
Both scientific cooperation and commercial use is possible, in accordance with Rules of CORE FACILITY labs and access is determined separately for each project in accordance with its specificity.