The main issues of quality assurance of radiopharmaceuticals
One of the prerequisites for successful application of nuclear medicine technologies is the production and clinical use of radiopharmaceuticals (RPs) of a reliably high quality. The aim of the review is to discuss specific properties of RPs, which stipulate specific approaches to their production (o...
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| Format: | Article |
| Language: | Russian |
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Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2019-12-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/288 |
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| author | G. E. Kodina A. O. Malysheva |
| author_facet | G. E. Kodina A. O. Malysheva |
| author_sort | G. E. Kodina |
| collection | DOAJ |
| description | One of the prerequisites for successful application of nuclear medicine technologies is the production and clinical use of radiopharmaceuticals (RPs) of a reliably high quality. The aim of the review is to discuss specific properties of RPs, which stipulate specific approaches to their production (or preparation) and quality control. The decisive requirement for the management of RPs at all stages of their life cycle is the observance of the radiation safety rules and regulations. The paper considers the main approaches to assessing the risks of medical radiation exposure to patients and radiation protection of nuclear medicine staff. The choice of a particular quality parameter and the corresponding analytical procedure should be made taking into account the duration of the test, which, like the production time, should be comparable with the radionuclide half-life. The feasibility of the analytical procedure should also be taken into account, given the high radioactivity of the samples tested. Now that theranostics has caught on, new approaches are being developed all over the world concerning regulatory aspects of transition from preclinical studies of RPs to clinical trials, because, according to experts, this is becoming a key condition for rapid implementation of nuclear medicine achievements. The results and conclusions of the present study can be used in the development and expert review of monographs and other specifications required for RP marketing and use. The results of the analysis suggest that it is necessary to develop specific requirements and guidelines for RP testing and evaluation for their successful promotion on the EAEU market. |
| format | Article |
| id | doaj-art-6f6b5eaf874f4ac58d2abea502aa27c7 |
| institution | Kabale University |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| publishDate | 2019-12-01 |
| publisher | Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) |
| record_format | Article |
| series | Регуляторные исследования и экспертиза лекарственных средств |
| spelling | doaj-art-6f6b5eaf874f4ac58d2abea502aa27c72025-08-20T03:57:31ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532019-12-019421623010.30895/1991-2919-2019-9-4-216-230223The main issues of quality assurance of radiopharmaceuticalsG. E. Kodina0A. O. Malysheva1Russian State Research Center — Burnasyan Federal Medical Biophysical Center of Federal Medical Biological Agency; DIAMED LtdRussian State Research Center – Burnasyan Federal Medical Biophysical Center of Federal Medical Biological AgencyOne of the prerequisites for successful application of nuclear medicine technologies is the production and clinical use of radiopharmaceuticals (RPs) of a reliably high quality. The aim of the review is to discuss specific properties of RPs, which stipulate specific approaches to their production (or preparation) and quality control. The decisive requirement for the management of RPs at all stages of their life cycle is the observance of the radiation safety rules and regulations. The paper considers the main approaches to assessing the risks of medical radiation exposure to patients and radiation protection of nuclear medicine staff. The choice of a particular quality parameter and the corresponding analytical procedure should be made taking into account the duration of the test, which, like the production time, should be comparable with the radionuclide half-life. The feasibility of the analytical procedure should also be taken into account, given the high radioactivity of the samples tested. Now that theranostics has caught on, new approaches are being developed all over the world concerning regulatory aspects of transition from preclinical studies of RPs to clinical trials, because, according to experts, this is becoming a key condition for rapid implementation of nuclear medicine achievements. The results and conclusions of the present study can be used in the development and expert review of monographs and other specifications required for RP marketing and use. The results of the analysis suggest that it is necessary to develop specific requirements and guidelines for RP testing and evaluation for their successful promotion on the EAEU market.https://www.vedomostincesmp.ru/jour/article/view/288radiopharmaceuticalradiation safetyradionuclidepharmacopoeiaproduction/preparationnuclear pharmacy |
| spellingShingle | G. E. Kodina A. O. Malysheva The main issues of quality assurance of radiopharmaceuticals Регуляторные исследования и экспертиза лекарственных средств radiopharmaceutical radiation safety radionuclide pharmacopoeia production/preparation nuclear pharmacy |
| title | The main issues of quality assurance of radiopharmaceuticals |
| title_full | The main issues of quality assurance of radiopharmaceuticals |
| title_fullStr | The main issues of quality assurance of radiopharmaceuticals |
| title_full_unstemmed | The main issues of quality assurance of radiopharmaceuticals |
| title_short | The main issues of quality assurance of radiopharmaceuticals |
| title_sort | main issues of quality assurance of radiopharmaceuticals |
| topic | radiopharmaceutical radiation safety radionuclide pharmacopoeia production/preparation nuclear pharmacy |
| url | https://www.vedomostincesmp.ru/jour/article/view/288 |
| work_keys_str_mv | AT gekodina themainissuesofqualityassuranceofradiopharmaceuticals AT aomalysheva themainissuesofqualityassuranceofradiopharmaceuticals AT gekodina mainissuesofqualityassuranceofradiopharmaceuticals AT aomalysheva mainissuesofqualityassuranceofradiopharmaceuticals |