Development of Methodological Documents Regulating the Clinical Trials of New Radiopharmaceutical Drugs
- Authors: Labushkina A.A.1, Klement'eva O.E.1, Kodina G.E.1, Samoilov A.S.1
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Affiliations:
- A.I. Burnazyan Federal Medical Biophysical Center
- Issue: Vol 68, No 3 (2023)
- Pages: 71-77
- Section: Nuclear Medicine
- URL: https://ogarev-online.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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Abstract
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
About the authors
A. A. Labushkina
A.I. Burnazyan Federal Medical Biophysical Center
Email: Lanar19@mail.ru
Moscow, Russia
O. E. Klement'eva
A.I. Burnazyan Federal Medical Biophysical Center
Email: Lanar19@mail.ru
Moscow, Russia
G. E. Kodina
A.I. Burnazyan Federal Medical Biophysical Center
Email: Lanar19@mail.ru
Moscow, Russia
A. S. Samoilov
A.I. Burnazyan Federal Medical Biophysical Center
Email: Lanar19@mail.ru
Moscow, Russia
References
- Kobyakova O.S., Kulikov E.S., Deev I.A., Dmitriev A.A., Tabakaev N.A., Pimenov I.D., Tyufilin D.S. Analysis of International Requirements for Designing of Clinical Trials. Razrabotka i Registratsiya Lekarstvennykh Sredstv = Drug Development & Registration. 2016;2:172-178 (In Russ.).
- 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;35;11:2144-2151. 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;4;2:2. doi: 10.1186/s41181-019-0055-6.
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