Bioavalibiti



Pharmacokinetic studies , including studies of bioequivalence and bioavailability of medicinal products are conducted ​​in the Department of Pharmacology . Their compliance with the principles of Good Laboratory Practice (GLP)has been certified by the Office for Chemical Substances ( Certificate No 6/2016/DPL ) . The Department of Pharmacology has done more than 70 studies for domestic and foreign pharmaceutical companies.

List of bioavailability and bioequivalence studies














Range of services:

> Preparation of the study draft.
> The development or adaptation of bioanalytical methods used for the determination of a drug substance and / or metabolites in biological material.
> Bioanalytical Method Validation in accordance with the EMA and FDA.
> Biological material determination (HPLC, LC / MS / MS) .
> Pharmacokinetic calculations ( WinNonLin ).
> Statistical Analysis System (SAS ).
> Documentation of research in the CTD format Module 5:
  > 5.3.1.2 . Reports on the comparative studies of bioavailability and bioequivalence
  > 5.3.1.4 . Reports on bioanalytical and analytical methods









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