Specifika klinických hodnocení léčiv časných fází I a II

Česká verzia

Authors: R. Demlová ^1,2; H. Kostková ¹; L. Součková ¹
Authors place of work: Farmakologický ústav, LF MU, Brno2 Masarykův onkologický ústav, Brno ¹
Published in the journal: Kardiol Rev Int Med 2015, 17(1): 87-91
Category: Internal Medicine

Summary

Drug research and development is a challenging and highly regulated process carried out according to Good Clinical Practice. The effectiveness of new drugs or new therapeutic combinations, including the safety data, has to be demonstrated in large controlled trials before registration. All these trials must be conducted in accordance with globally recognized standards for the conduct of clinical trials. Early stage clinical trials phase I and II follow the preclinical experiments and have their own specifics. Phase I clinical trials usually enroll healthy volunteers; patients are enrolled only in exceptional cases. The primary endpoint of these studies is to establish the recommended dose for subsequent phase II trials. Dose escalation takes into account also the results of preclinical testing and is planned based on the principle of minimizing risks for the study subjects. Important parts of the early phases of clinical trials are also pharmacokinetic and/ or pharmacogenetic studies as well as the evaluation of adverse drug reactions.

Key words:
clinical trials – drug development – pharmacokinetics – phase I and II

Zdroje

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