Bioavalibiti



Pharmacokinetic studies, including studies of bioequivalence and bioavailability of medicinal products are conducted in the Pharmacokinetics Department . Their compliance with the principles of Good Laboratory Practice (GLP) has been certified by the Bureau for Chemical Substances ( Certificate No 4/2018/DPL ) More than 80 studies were conducted in the Pharmacokinetics Department for domestic and foreign pharmaceutical companies.

List of bioavailability and bioequivalence studies














Range of services:

> Study design: number of subjects, blood sampling time-points, analyte selection, etc.
> Bioanalytical method development: determination of drugs and metabolites in biological matrices (plasma, serum, etc.) using liquid chromatography coupled to mass spectrometry (LC-MS) and ultrahigh performance liquid chromatography (UHPLC)
> Bioanalytical method validation: according to European Medicines Agency (EMA) Guideline
> Pharmacokinetic calculations: AUC, Cmax, Tmax, T1/2 etc. using Phoenix WinNonlin software by Certara
> Study documentation: for submission to regulatory authorities in Common Technical Document (CTD) format
> Expert opinion: regulatory and corporate purposes, incl. non-standard study design and risk assessment
> Pharmacokinetic study management: incl. clinical site selection and the clinical part of studies









The laboratory collaborates closely with clinical centers that meet the requirements of Good Clinical Practice (GCP):


Trial s.c. – Ośrodek Badań Klinicznych http://www.trial.pl
MTZ Clinical Research Sp. z o.o. http://www.mtz-clinical.pl

Head of Department:Piotr Rudzki, Ph.D.
Land line:(+48 22) 456 38 49
Mobile:601 585 453
Fax:(+48 22) 456 38 38
E-mail: p.rudzki@ifarm.eu