Magdalena Rucińska, Izabela Fraj, Justyna Truszyńska, Dorota Górska

Znaczenie IV fazy badań klinicznych w ocenie bezpieczeństwa nowych leków
2006-12-01

The clinical studies of the phase IV in the new drugs safety evaluation. The new drugs, before they will be admitted to therapy are being subjected for long-lasting, expensive pre-clinical and clinical examinations. The examination of the 3rd phase, as multicenter randomized clinical research, directly preceding the new medicine registration. Sometimes but rarely occurring dangerous undesirable action which in post-licensing studies (phase IV) is possible to evaluate. When the drugs are used by the large group of patients (after introducing the medicine into the market) is possible to evaluate their real safety. Some medicines as cerivastatine and rofekoksib were withdrawn from sale because of their undesirable action. The use of felbamat is continued to application with particular care.