ISSN: 1300-0292
İndekslendiği Dizinler: SCIENCE CITATION INDEX EXPANDED
CINAHL, Index Copernicus,
Chemical Abstracts (CA),
Excerpta Medica / EMBASE
Dil: Türkçe, İngilizce
İçerik: Orijinal Araştırma, Derleme, Editöre Mektup, Olgu Sunumu, Tıp Eğitimi, Tıbbi Kitap İncelemeleri
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ORIGINAL RESEARCH ARTICLES |
Participants Profile In Drug Bio Equivalency Trials
Dr.M. Mümtaz MAZICIOĞLU,a,b Dr.Berrin GÖĞÜSTEN, b Dr.Aydın ERENMEMİŞOĞLUb,c
aAile Hekimliği AD, bİyi Klinik Uygulama Merkezi, cFarmakoloji AD, Erciyes Üniversitesi Tıp Fakültesi, KAYSERİ
Objective: Drug bio-equivalency trials have been conducted in Erciyes University Medical Faculty Hakan Çetinsaya Good Clinical Practice Centre since 2000.
Material and Methods: Volunteers who were recruited from all 39 drug bio-equivalency trials carried out in one year were evaluated in order to determine their profile.
Results: A total of 579 volunteers were recruited: 260 (44.9%) students, 149 (25.7%) workers, 73 (12.6%) clerks, 59 (10.2%) small-scale retailers and 33 (5.7%) unemployed. Volunteers stated that the principal reason for recruitment was additional income (n=390 or 67.4%). When participants were grouped according to monthly income, we determined that 205 (35.4%) earned less than 250 million TL, 246 (42.5%) earned between 150-350 million TL and 79 (13.6%) earned more than 300 million; 49 (8,5%) did not state how much they earned. The participants’ own statements were used to determine individual monthly incomes.
Conclusion: We submit that the principal reason for becoming a volunteer in drug bio-equivalency trials is additional income. The apparent rarity of severe adverse effects occurring in previous trials appears to induce trust in researchers and in bio-equivalency trials.Keywords: Clinical drug trials, volunteers, bioequivalencyTurkiye Klinikleri J Med Sci 2004, 24:328-331
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