Abstract

CASTRO ALFONSO, Yusniel. Regulatory aspects of the non-clinical researches in the Isotope Center . Nucleus [online]. 2017, n.62, pp. 43-46. ISSN 2075-5635.

For the quality control of radiopharmaceuticals produced by Centis and in pharmacokinetic studies carried out in this institution, scintigraphic images of animals are obtained. This allows the assessment of the distribution and behavior of these radiolabeled molecules inside the organism in order to use them in clinical trials in people having different pathologies. Besides  following the CNSN regulations involving work with open radioactive sources, non-clinical research laboratory areas are subject to  Biosafety Regulations particularly those established by Cecmed. The world trend to integrate the management systems in the organization processes requires the harmonization of Good Laboratory Practices, the compliance with Biosafety Regulations and International Standards concerning the ethics, when working with laboratory animals. This kind of laboratory coordinates its services directly with institutions developing drugs and with the Department of Quality Control for Products used in Nuclear Medicine in Centis. The present work is aimed at assessing the legislation and regulations related with non-clinical research area to take actions intended to improve the integrated management of biosafety for structuring a safety program

Keywords : drugs; labelled compounds; nuclear medicine; quality assurance; regulations.

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