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EGE UNIVERSITY

Research and Application Center of Drug Development and Pharmocokinetics

About Us

Bioanalytical Laboratory

ARGEFAR Bioanalytical Laboratory; has been established with the aim of making analyzes in pharmaceutical research, primarily bioavailability and bioequivalence studies.

 

 

 

Activity Area

Bioavailability and Bioequivalence studies in İzmir single is one of the few institutions in Turkey. Development of methods for determination of drug levels in all kinds of tissues and biological fluids, validation and qualitative / quantitative analyzes are performed in line with international guidelines.

Our Work

  • The first bioequivalence study was started in May 2005.
  • As of March 2017, 61 studies have been completed.

Quality Management System

For Our Customers,

Our aim is to offer our services that meet / meet the evolving requirements in the national / international field, always, quickly, accurately, at the most cost-effective, respectful to our confidentiality and agreements, and to provide customer priority, to receive feedback and to minimize any complaints. Openness and trust are essential in relationships.

Our work,
 
“Good Clinical Practices (IKU) Guide”, “Good Laboratory Practices (ILU) Guide” and “TS EN ISO / IEC 17025 tam are in full compliance with the basic requirements of international standards and in accordance with the relevant procedures / methods. Accuracy of results is a priority. In case of any negative results, the whole working system is reviewed and verified, and if necessary, our customers are informed.
 
Our employees,

“Good Professional Practices” is based on the principles of independence, impartiality and openness with a management approach free from internal / external pressures and conflicts of interest. The importance of their work is explained to our employees and their training takes priority.

Our Yönetim Quality Management System,

Ensuring the effectiveness of our system that we have established to ensure the quality of our work / results is within the scope of the “Continuous Improvement” objectives and all necessary measures have been taken to prevent the changes to be made affecting the operation of the system.

Our Organization,

It is an organization that continuously develops and develops by sharing information.

As Senior Management,

All kinds of contributions are made in order to develop the Yönetim Quality Management System ve and reach the defined targets, and all processes are followed and finalized. In order to ensure independence and impartiality; Protection of impartiality against all parties; maintaining independence without being affected by commercial, financial and other external pressures; it is our promise to provide all logistical resources considered / envisaged.

 
  • Our Yönetim Quality Management System onaylanmış has been approved by the Ministry of Health in accordance with the principles of Good Laboratory Practices (ILU).
  • All studies and follow-up are carried out in accordance with the quality standards and in accordance with the Laboratuvar Good Laboratory Practices (ILU) Guide.
  • As the most important step of bioavailability and bioequivalence studies, “Analytical Method Validation” criteria are applied one-to-one and accuracy is ensured.

Laboratory Infrastructure

In ARGEFAR Bioanalytical Laboratory; Test Item Acceptance & Cold Archive Unit, Sample Preparation Units, Analytical Studies Unit, Lounge, Storage and Archive Units.
 
            

Device Infrastructure

  • 1 HPLC-DAD
  • 1 Piece HPLC-UV
  • 1 Piece HPLC-FLD
  • 2 Pieces LCMS / MS
  • 1 Piece pH meter
  • 1 Scales
  • 1 Piece Shaker
  • 2 Pieces Vortex
  • 1 Piece MultiVortex
  • 1 Piece Ultrasonic Water Bath
  • 2 Units Refrigerated Centrifuge
  • 3 Pcs Vacuum Concentrator
  • 2 Units Nitrogen Generator
  • 1 Piece + 4 ° C Refrigerator
  • 1 Piece -20 ° C Freezer
  • 6 Pieces -80 ° C Freezeru

Staff

Within the scope of Bioavailability and Bioequivalence studies, the Company provides services with 4 personnel including 3 Research Operator qualified and competent in analytical working processes.