Bioanalytical laboratory has participated in more than five hundred studies of bioequivalence and pharmacokinetics of drugs. The laboratory has 18 chromato-mass spectrometers, which allow high-precision determination of low molecular weight compounds in biological samples.
The quality management system is certified in accordance with ISO 9001:2015, the principles of good laboratory practice GLP.
Bioanalytical laboratory services
Development and validation of bioanalytical methods
The development and validation of bioanalytical methods for the quantitative determination of drugs in various biological matrices is carried out in accordance with current recommendations.
Achievable limit of quantitation
– from 1 pg/ml.
Result: quantitative
Research method: HPLC-MS/MS, ELISA
Analysis of the concentration of drugs in biological objects
Quantitative determination of low molecular weight drugs by HPLC/MS/MS, as well as biotechnological drugs by ELISA.
Result: quantitative
Research method: HPLC-MS/MS, ELISA
Study of drug metabolism
- Inhibition of the CYP P450 system
- Stability in plasma/microsomes/s9
- Identification of metabolites
Result: quantitative
Research Method: HPLC/MS/MS, ADME
Conducting preclinical ADME studies
- Solubility of drugs (Shake-flask, Millipore solubility assay)
- Permeability through lipid layers (PAMPA/BAMPA)
- Plasma protein binding (PPB)
Result: quantitative
Research method: HPLC-MS/MS, HPLC-UV and other methods
Data analysis
Calculation and construction of pharmacokinetic curves, statistical data processing using Phoenix® WinNonlin® licensed software.
