Medical Radiology and Radiation Safety. 2023. Vol. 68. № 3

DOI: 10.33266/1024-6177-2023-68-3-71-77

A.A. Labushkina, O.E. Klement’eva, G.E. Kodina, A.S. Samoilov

Development of Methodological Documents Regulating
the Clinical Trials of New Radiopharmaceutical Drugs

A.I. Burnazyan Federal Medical Biophysical Center, Moscow, Russia

Contact person: Anna A. Labushkina, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Contents

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

Keywords: clinical studies, radiopharmaceutical drug, rules of good clinical practice, researcher’s brochure, protocol of clinical research, normative documentation

For citation: Labushkina AA, Klementyeva OE, Kodina GE, Samoilov AS. Development of Methodological Documents Regulating the Clinical Trials of New Radiopharmaceutical Drugs. Medical Radiology and Radiation Safety. 2023;68(3):71–77. (In Russian). DOI: 10.33266/1024-6177-2023-68-3-71-77

References

1. 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.).

2. 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.

3. 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.

 PDF (RUS) Full-text article (in Russian)

Conflict of interest. The authors declare no conflict of interest.

Financing. The study had no sponsorship.

Contribution. Article was prepared with equal participation of the authors.

Article received: 20.01.2022. Accepted for publication: 25.02.2023.