The pharmacokinetic studies, including bioavailability and bioequivalence, are performed in the Pharmacology Department. Our services are in full compliance with OECD GLP (Statement of GLP Compliance No. 2/2010/GLP issued by Bureau for Chemical Substances and Preparations). We have performed over 60 studies for domestic and foreign pharmaceutical companies.

0.1 MB List of bioequivalence and bioavailability studies

Our services include:

1. Literature studies and development of a study plan.
2. Development or adaptation of bioanalytical methods for the determination of active substance and/or metabolites in biological fluids.
3. Bioanalytical method validation according to EMEA and FDA.
4. Determination of active substance and/or metabolites concentration in biological fluids (HPLC, LC/MS/MS).
5. Pharmacokinetic parameters calculation (WinNonLin).
6. Statistical analysis (SAS System for Windows).
7. Study documentation in CTD Module 5 format:
• 5.3.1.2. Comparative and Bioequivalence Study Reports
• 5.3.1.4. Reports of Bioanalytical and Analytical Methods for Human Studies

Sample preparation

Mass Spectrometer LCMS-2010

GCP compliant partner research organizations: