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 4/2018/DPL). We cooperate with academic and research centres in the area of in vitro comparative study models and new bioanalytical techniques and methods. Our contractors include domestic and foreign pharmaceutical companies. Our staff is involved in consulting of draft EMA guidelines. Bioequivalence studies has been conducted in the Pharmacokinetics Department since 1983. Until 2017 we were known as Pharmacology Department. Detailed data on the services and cooperating clinical sites (GCP) can be found in the 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:

  • 5 employees with higher education degrees (including 3 Ph.Ds)
Head:Piotr Rudzki, Ph.D.
Land line:(+48 22) 456 38 49
Mobile:(+48) 601 585 453
E-mail: p.rudzki@ifarm.eu