The importance of genotoxicity tests in new drug development process Genotoksisite testlerinin yeni ilaç geliştirme sürecindeki önemi

In the preclinic investigation period at the beginning of the drug development process, it is an obligation to subject candidate drugs to genotoxicty investigations. Genotoxicty data of drugs that are developed with these tests are demanded as a part of the security evaluation process by regulatory authorities in various countries. The demand of these laboring and costly data by regulatory authorities of various countries in different standards prevents potential candidate drugs from being marketed, interrupts the drug development process and causes unnecessary utilization of experimental materials in researches. Therefore, nowadays,  it is generally accepted that the researches aimed at achieving these data are implemented with standardized approaches in the guidelines of international harmonisation organizations such as ICH (International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and OECD (Organisation for Economic Cooperation and Development). In this review, it is aimed to provide current information about the various genotoxicity tests which are used commonly in the drug development process, in accordance with ICH, OECD guidelines and literature. Extended English summary is in the end of  Full Text  PDF (TURKISH)  file . Ozet Ilac gelistirme surecinin baslangicindaki preklinik arastirma doneminde, aday ilaclarin genotoksisite testlerinden gecirilmesi bir zorunluluktur. Bu testlerle elde edilen genotoksisite verileri, cesitli ulkelerdeki duzenleyici otoriteler tarafindan guvenlilik degerlendirme surecinin bir parcasi olarak istenmektedir. Elde edilmesi oldukca zahmetli ve maliyetli olan bu bilgilerin, farkli ulkelerin duzenleyici otoriteleri tarafindan degisik standartlarda istenmesi, potansiyel ilac adaylarinin pazarlamasini engellemekte, ilac gelistirme surecini kesintiye ugratmakta ve arastirmalarda gereksiz yere deney materyali kullanimina neden olmaktadir. Bu bakimdan, gunumuzde bu bilgileri elde etmeyi amaclayan arastirmalarin, ICH (Insanda Kullanilan Ilaclarin Ruhsatlandirilmasi Icin Teknik Gerekliliklerin Uyumlandirilmasi Uluslararasi Birligi) ve OECD (Ekonomik Kalkinma ve Isbirligi Orgutu) gibi uluslararasi harmonizasyon orgutlerinin kilavuzlarinda standardize edilen yaklasimlarla uygulanmasi genel kabul gormektedir. Bu derlemede, ilac gelistirme surecinde kullanilan genotoksisite testlerine iliskin, ICH, OECD kilavuzlari ve literatur isiginda guncel bilgiler verilmesi amaclanmistir.