[Report on the experience of clinical trials performed according to GCP].
As well known GCP is described more accurately by Good Clinical Research Practice, Good Clinical Trial Practice and Good Clinical Regulatory Practice. The Authority (National Institute of Pharmacy) from 1st January 1994 required that clinical trials phase I-II-III had to be performed in accordance with the GCP guideline (appeared in 1992 in edition of NIP). We tried to present in what follows a brief account of our experience considering the performance of clinical trials in accordance with Good Clinical Practice requirements.
Lörinczi
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EGIS Gyógyszergyár Rt., Kutatásellenörzési osztály, Budapest.
D002986:Clinical Trials as Topic / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D006814:Hungary; D011785:Quality Assurance, Health Care