Pharmacology Department performs pharmacokinetic studies, including bioavailability and bioequivalence, according to the current EMA and FDA guidelines. We cooperate with domestic and foreign pharmaceutical companies. Since the year 2003 our services are in full compliance with OECD Good Laboratory Practice requirements, as comfirmed by Bureau for Chemical Substances and Preparations (GLP Statement No. 2/2010/GLP) and SNAS (GLP Statement No. G 019). We have performed over 60 studies of bioavailability and bioequivalence in our Laboratory. The results of research are presented at conferences and printed in international journals. The scientific personel of Pharmaclgy department is involved in public consultations of novel EMA guidelines. Experienced and qualified staff and high-quality modern equipment guarantee that the studies will be carried out properly. Detailed data on our offer and GCP compliant partner research organizations are presented in the Offer section.

0.1 MB List of bioequivalence and bioavailability studies

LC/MS/MS: Quattro Micro

Automated SPE: Aspec XL

Key equipment of Laboratory of Drugs Bioavailability:

• Tandem mass spectrometer Quattro Micro (Micromass / Waters) coupled with HPLC system (LC/MS/MS)
• Mass spectrometer LCMS-2010 (Shimadzu) coupled with HPLC system (LC/MS)
• HPLC systems with UV-VIS, electrochemical and fluorescence detectors
• Automated solid phase extraction (SPE) system - Aspec XL (Gilson)

Staff:

• Scientific staff - 8 persons (including 4 Ph.Ds)
• Technical staff - 2 persons