Gazi University has got PHASE 1 Clinical Research Center Compliance Certificate
30 Ocak 2018 11:04

Gazi University Faculty of Medicine Department of Pediatric Metabolism took the "Phase I Clinical Compliance Certificate for Pharmaceutical Research "on January 5, 2018" which is taken fifth in Turkey. This Clinical Research Center was the first center in Ankara.



In Turkey, our center is the first unit to do drug research on rare diseases and Phase I study for the treatment of two rare inherited metabolic diseases will start in a short time. This study aims to lead the development of domestic treatment methods from research to production in disease groups such as mucopolysaccharidosis, which is the cause of death and disability, especially in childhood, all over the world as much as it is in our country.

Phases of clinical drug trials are as follows:

Phase 0: They are preclinical studies.  The response to the effect is investigated by applying the developed drug in experimental animals or in human microdoses.

Phase 1: The pharmacokinetic properties, toxicity, bioavailability, pharmacological effects of the developed drug are investigated in a small number of healthy volunteers. The main objective of this phase is reliability.

Phase 2: Effective dose limits, clinical efficacy, biological activity, benefit and safety of the drug are sought in a small number of patients. At this stage the optimum dose and dose ranges are calculated. The main purpose of this phase is efficiency and reliability.

Phase 3: Drugs that pass the first and second stages are tested in a wider population and their efficacy is investigated through placebo-controlled studies with reliability and comparative studies. The main purpose of the phase is to demonstrate the effectiveness and monitor side effects.

Phase 4: Drugs that pass the first 3 stages are licensed and put on the market. Any work done after the marketing belongs to the 4th phase.



Gazi University Faculty of Medicine Department of Child Metabolism