Sánchez BJJ, García VJL, Frati MAC

Language: Spanish
References: 19
Page: 265-272
PDF size: 78.01 Kb.

ABSTRACT

Clinical assays that evaluate the effect of medicines are carried out by means of investigation protocols in which pharmacologic aspects of a medication are studied, in addition to its effectiveness and clinical security in humans. These drugs must contain several components that allow giving of answers to questions raised by the investigations. The protocol must fulfill a number of both Mexican and international scientific and normative requirements. The primary target of this work was to reflect upon and reflection and emphasize certain methodologic aspects of clinical trials for the study of drugs, associated to the bioethical dimension from a point of view regulatory. In this work we make an analysis of legal, methodolo-gical and bioethical components normative important that must be accomplished clinical pharmacological investigations as establishes the General Law of Health in its Regulation of Investigation, the good clinical practices of investigation and the norms that establishes the Declaration of Helsinki.

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