It was accepted that success is a journey, not a destination; experience is thought and thought is acted as the child of action and ve G ARGEFAR Klinik (I and II) ’’ in the light of the purpose of establishment; Turkey's existing potential in terms of Clinical Research poses more effective steps to use certain principles in order to request and participate in international activities in the presence of Prof. strick Dr. Under the leadership of Işık TUĞLULAR, the foundation of ARGEFAR Klinik I was laid in 2001 and ARGEFAR Klinik II was opened in 2011.
- ARGEFAR Clinic (I and II), which is “Bioavailability / Bioequivalence Research” and “Phase Studies alar, is a unit of“ Drug Development and Pharmacokinetics Research and Application Center (ARGEFAR) E within EGE UNIVERSITY RECTORATE.
- ARGEFAR Clinic I for Bioavailability and Bioequivalence studies and Clinic II for PHASE I studies. The Ministry of Health has been approved by the Ministry of Health. Also every 2 years T.C. Turkey audited by the Ministry of Health Medicines and Medical Devices Agency, certifications are renewed.
Purpose / Reason for Establishment
- In general, the main purpose of drug clinical research is to find answers to specific and specific health problems, and a carefully conducted clinical research helps to produce important and useful solutions to the health problems of people and / or communities. Considering the importance of this basic purpose, nowadays drug clinical research has become compulsory research to meet the needs of the society.
- In the light of the most up-to-date information, the high standard of drug clinical research and dissemination is essential for the development of medicine and science and for the protection of human health.
- It is also known that clinical research is of great importance in order to fight public health more effectively and to increase the quality of life to higher levels.
- To be the first applied clinic with world-class knowledge and skills in the field of pharmaceutical research concerning public health, which cannot be denied to contribute to the development of the pharmaceutical industry.
- To share information and experience with relevant sectors as an exemplary research clinic based on ethical values in order to improve all processes related to clinical research (within the framework of national legislation, European Union and world norms), to improve quality and to eliminate problems in processes.
- 'Bioavailability and Bioequivalence' research,
- 'PHASE' research
Bioequivalence; two drugs having the same pharmaceutical form have equivalent effects. To demonstrate bioequivalence, the maximum plasma concentrations of drugs (Cmax), the time to reach Cmax (tmax), and the areas under the plasma concentration-time curve (AUC0-∞) of drugs are generally compared in 24 healthy volunteers.
Bioavailability; is used to indicate the ratio of the amount of drug to systemic circulation that remains unchanged. In determining bioavailability, a single dose is usually administered in 12 healthy volunteers for each drug, and the plasma concentration time curve of the drug is drawn from the time of administration until the drug elimination is completed.
Phase I studies: Generally, in healthy volunteers, 20-80 people are collecting safety data related to the product, determining the dose range, examining the tolerable dose and pharmacokinetic properties. The main purpose of this phase is 'safety'. Phase I studies can also be performed on patient volunteers in some cases.
In May 2005, ARGEFAR Clinical Research Unit started its clinical research with “Bioavailability and Bioequivalence kez studies.
- ARGEFAR Clinical Research Unit (KAB) serves with Clinical Research Physician, Clinical Research Pharmacist, Clinical Research Nurse, Quality Manager, Laboratory Officer, Clinical Research Assistant, Clinical Secretary and Support Personnel, each of whom is experienced in the field of Clinical Research.
- Depending on the design of the studies, physician, nurse and support worker services are provided by taking special services from outside during the clinical studies when necessary. These personnel work under contract with ARGEFAR and their training is effectively provided and updated by ARGEFAR KAB team.
Clinic I and II Infrastructure
In our clinics, where all necessary equipment and equipment are always available for safe and healthy research, the health and well-being of our volunteers are provided with the necessary space and facilities to spend time during their stay. Based on this;
- In ARGEFAR Klinik I, a 2-bed unit with a total capacity of 27 beds, a relaxation room, a dressing room, toilet, shower and dining room, as well as an Examination Room where volunteers are controlled, a Research Product Room where study products are stored and protected, Blood Collection There is a room, a laboratory where samples are taken and 2 meeting rooms.
- In ARGEFAR Clinic II; 3-bed unit with a total capacity of 15 beds, also defined in Clinic I, Volunteer Recreation Room, Dressing Room, Toilet, Shower, Dining Room, Examination Room, Research Product Room, Blood Collection Room and Laboratory as well as Volunteer Information Hall, Screening Unit, Cold Archive , Intensive Care Room (1 bed), Archives, Research Staff Rest Room and Clinical Research Unit / Data Management Room.
- ARGEFAR Clinic I and II have the necessary equipment and the distance to the Ege University Emergency Department is 300 meters.
- There is no doubt that the rights and responsibilities of volunteers in Clinical Trials are more important than the designs, methodologies and scientific technical infrastructure of the research. Therefore, all records related to volunteers should be kept confidential. The data of all volunteers applying to ARGEFAR Clinical Research Unit, which always acts with this principle, are recorded in a system called “E- Candidate Volunteer Database”. All relevant records are kept on this system, allowing only certain persons to access them.