Development of Methodological Documents Regulating the Clinical Trials of New Radiopharmaceutical Drugs
- Autores: Labushkina A.A.1, Klement'eva O.E.1, Kodina G.E.1, Samoilov A.S.1
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Afiliações:
- A.I. Burnazyan Federal Medical Biophysical Center
- Edição: Volume 68, Nº 3 (2023)
- Páginas: 71-77
- Seção: Nuclear Medicine
- URL: https://journal-vniispk.ru/1024-6177/article/view/363841
- DOI: https://doi.org/10.33266/1024-6177-2023-68-3-71-77
- ID: 363841
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Texto integral
Resumo
Introduction
The forms of radiopharmaceutical drugs clinical trial protocols
The forms of the researcher’s brochure for clinical studies of radiopharmaceutical drugs
The forms of reports on the results of clinical trials for radiopharmaceutical drugs
Conclusion
Sobre autores
A. Labushkina
A.I. Burnazyan Federal Medical Biophysical Center
Email: Lanar19@mail.ru
Moscow, Russia
O. Klement'eva
A.I. Burnazyan Federal Medical Biophysical Center
Email: Lanar19@mail.ru
Moscow, Russia
G. Kodina
A.I. Burnazyan Federal Medical Biophysical Center
Email: Lanar19@mail.ru
Moscow, Russia
A. Samoilov
A.I. Burnazyan Federal Medical Biophysical Center
Email: Lanar19@mail.ru
Moscow, Russia
Bibliografia
- Кобякова О.С., Куликов Е.С., Деев И.А., Дмитриев А.А., Табакаев Н.А., Пименов И.Д., Тюфилин Д.С. Анализ международных требований к комплексному проектированию клинических исследований лекарственных средств // Разработка и регистрация лекарственных средств. 2016. № 2. С. 172-178.
- Verbruggen A., Coenen H.H., Deverre J.R., Guilloteau D., Langstrom B., Salvadori P.A., Halldin C. Guideline to Regulations for Radiopharmaceuticals in Early Phase Clinical Trials in the EU // Eur. J. Nucl. Med. Mol. Imaging. 2008. V.35, No. 11. P. 2144-2151. doi: 10.1007/s00259-008-0853-7.
- Peñuelas I., Vugts D.J., Decristoforo C., et al. The New Regulation on Clinical Trials in Relation to Radiopharmaceuticals: When and How Will It Be Implemented? // EJNMMI Radiopharm. Chem. 2019. V.4, No. 2. P. 2. doi: 10.1186/s41181-019-0055-6.
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