Unifarm University Consortium (Consorzio Universitario Unifarm, UNIFARM) was founded in Catania in 2002 by Filippo Drago, Professor of Pharmacology at the School of Medicine, University of Catania, in cooperation with the University of Catania and twelve major multinational pharmaceutical companies. In the same year the Research Centre in Clinical Pharmacology the first in Central...read more

UNIFARM is a CRO registered at  the Agenzia Italiana del Farmaco (Italian Authority for Drugs, AIFA), compliant with the requirements of the DM (Ministerial Decree) dated March 31, 2008 on clinical trials and therefore able to provide services such as: clinical study design; project management; preparation of study protocols and other regulatory documents; approval procedures...read more

UNIFARM has implemented a Quality System in line with national and international regulations to ensure high level of service and client satisfaction. Indeed, this is one of the main objectives of UNIFARM and is constantly pursued through the involvement of all the personnel in a quality process based on the assumption of individual responsibility, as well as through the implementation of systems and procedures...read more

Analytical Department

 

The bioanalytical laboratory of UNIFARM is certified by the Azienda Sanitaria Provinciale of Catania according to D.M 19/03/1998 and is included in the Registry of private laboratories of the OsSC.
 
The laboratory performs bioanalyses of biological materials (blood, plasma, serum, urine, tissue and others) according to GLP (Good Laboratory Practice).
 
The skill and technical-scientific expertise of its staff, as well as  the high level of equipment available allow UNIFARM to have an advanced laboratory able to develop validated analytical methods according to international guidelines.
 
In particular the laboratory is able to:
develop and validate analytical methods;
determine active ingredients and metabolites in pharmacokinetic and pharmacodynamic studies;
determine marker levels in bioequivalence and bioavailability studies;
prepare validation reports;
prepare analytical reports;
prepare SOPs.
 
The main analytical equipments are:
HPLC/DAD (Varian);
HPLC/ECD (ESA); 
HPLC/MS/MS (Agilent). 
 

Examples of bioanalytical validation methods

Compound

Matrix

Method

9-Idroxy-risperidone

plasma

LC-MS/MS

Acetyl-L-carnitine

plasma

LC-MS/MS

Daidzein

siero

HPLC/ECD

Desketoprofene

plasma

LC-MS/MS

Dexamethasone

plasma

LC-MS/MS

Frovatriptan

plasma

LC-MS/MS

Diclofenac

plasma

LC-MS/MS

Eperisone

plasma

LC-MS/MS

Escitalopram

plasma

LC-MS/MS

Fluvastatin

plasma

LC-MS/MS

Genistein

siero

HPLC/ECD

L-carnitine

plasma

LC-MS/MS

Olanzapine

plasma

LC-MS/MS

Propyonil-L-carnitine

plasma

LC-MS/MS

Riluzole

plasma

LC-MS/MS

Risperidone

plasma

LC-MS/MS

Simvastatin

plasma

LC-MS/MS

Simvastatin-β-hydroxyacid

plasma

LC-MS/MS

Thiocolchicoside

siero

HPLC/ECD

Triazolam

plasma

HPLC/UV

 

 

Unifarm è un Centro di Saggio (CdS) certificato dal Ministero della Salute,
in Buona Pratica di Laboratorio (BPL)