Improvement of regulatory framework for conducting preclinical studies of x-ray contrast agents

This paper analyses modern hi-tech methods of diagnosing health problems with the help of X-ray contrast agents used in combination with such technologies as magnetic resonance imaging, single-photon emission computer tomography, etc. The lack of Russian diagnostic drugs is the main hindrance to a wide clinical use of advanced medical diagnostic technologies. The article demonstrates the necessity of developing guidelines which would standardize the scope and nature of preclinical studies for all classes of X-ray contrast agents. The article suggests the main concepts that the guidelines should contain: the definition of the term «diagnostic drug»; the classification of diagnostic drugs by their chemical structure and/or pharmacological action; the required scope of obligatory and additional studies for new drugs and for new indications for already approved drugs; the objectives of experimental pharmacokinetic studies and acceptable methods of obtaining primary data; the list of methods to be used for electronic processing of primary data; evaluation of X-ray contrast agents safety (especially radiopharmaceuticals and PET radiopharmaceuticals), and the standard protocol of test results.

нормативные документы, контрастно-диагностические препараты, методы магнитно-резонансной томографии, радиофармацевтические препараты, доклиническое исследование диагностических средств, regulations, X-ray contrast agents, magnetic-resonance, radiopharmaceuticals, preclinical study of diagnostic drugs

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