Improvement of regulatory framework for conducting preclinical studies of x-ray contrast agents
| Autor: | V. N. Kulakov, A. A. Lipengolts, E. Yu. Grigorieva, N. L. Shimanovsky |
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| Jazyk: | ruština |
| Rok vydání: | 2018 |
| Předmět: |
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 Medicine (General) R5-920 |
| Zdroj: | Регуляторные исследования и экспертиза лекарственных средств, Vol 7, Iss 1, Pp 55-58 (2018) |
| Druh dokumentu: | article |
| ISSN: | 3034-3062 3034-3453 |
| Popis: | 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. |
| Databáze: | Directory of Open Access Journals |
| Externí odkaz: |
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