Specifika klinických hodnocení léčiv časných fází I a II

Title in English Specifics of early strage clinical trials of drugs in phases I and II


Year of publication 2015
Type Article in Periodical
Magazine / Source Kardiologická revue - Interní medicína
MU Faculty or unit

Faculty of Medicine

Field Pharmacology and pharmaceutical chemistry
Keywords clinical trials; drug development; pharmacokinetics; phase I and II
Description 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.
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