Pharmacology Department



Pharmacology Departmentperforms pharmacokinetic studies, including bioequivalence and bioavailability of medicinal products, in compliance with EMA and FDA guidelines. Since 2003 all work in thePharmacology Departmenthas been done in accordance with Good Laboratory Practice, which has been recognized by means of GLP certificates issued by the Bureau for Chemical Substances (Certificate no 6/2016/DPL). Departmenthas carried out over 80 bioavailability and bioequivalence studies. It has been cooperating with academic and research centres in the area of in vitro comparative study modelsand new bioanalytical techniques and methods. Its contractors include domestic and foreign pharmaceutical companies.The Pharmacology Departmentemployees are involved in consulting prospective new EMA guidelines. The qualified and experienced personnel equipped with state of the art instruments guarantees that all projects are carried out properly and on time. Detailed data on the range of the services offered and cooperating clinical centres (GCP) can be found in thee Research offer.

List of validated bioanalyticalmethodsand conducted bioavailability and bioequivalence studies


Free on-line tool for visual presentation of incurred sample reanalysis (ISR) data developed by Pharmaceutical Research Institute and Warsaw University of Technology is available at http://52.31.27.158/isr/ .
This tool assists the paper published in Bioanalysis, Vol.9, No.12.

Pharmacology Department uses the following equipment:

  • Quattro Micro API (Waters) tandem mass spectrometercoupled with HPLC (LC/MS/MS)
  • LC/MS-2010 (Shimadzu) mass spectrometer coupled with HPLC (LC/MS)
  • UHPLC and HPLC with UV-VIS, electrochemical and fluorometric detection
  • Aspec XL (Gilson) automated solid phase extraction instrument

Personnel:

  • 7 employees with higher education degrees(including 1 holder of a professorial degreeand 2 with a doctoral degree)
  • 1 technician
Head:Piotr Rudzki, Ph.D.
Land line:(+48 22) 456 38 49
Mobile:(+48) 601 585 453
E-mail: p.rudzki@ifarm.eu