@article{collins_traceability_2024,
	title = {Traceability for radionuclides},
	rights = {Creative Commons Attribution 4.0 International},
	url = {https://zenodo.org/doi/10.5281/zenodo.11093646},
	doi = {10.5281/ZENODO.11093646},
	abstract = {Radionuclides play an important role in the diagnosis of a range of key diseases or for the delivery of targeted cancer therapies. This unique capability has been utilised for decades and drives the development of new radiopharmaceuticals using well known radionuclides and the search for novel radionuclides that can expand the pool of treatments available and lead to improvements in patient outcomes. The development and manufacture of these radiopharmaceuticals and use in a patient requires the accurate measurement of the activity of the radionuclide to provide the efficient and safe use of the drug.

To achieve this, regulators look to radiopharmaceutical manufacturers and radiopharmacies to be capable of accurately measuring the activity of the radionuclide present in a manner traceable to national or international standards of activity. Traceability provides the best route to ensure that the measurement devices being used, and their calibrations are providing accurate results, through a documented unbroken chain of calibrations.

As new radionuclides are identified and developed for use in nuclear medicine National Metrology Institutes ({NMIs}) play a crucial role in developing these national and international standards through the realisation of primary standards of activity of the radionuclide. The {NMIs} are responsible for providing a method for disseminating these standards to the radiopharmaceutical manufacturers, radiopharmacies and clinics to provide the link to the {SI} unit of the becquerel and give confidence in the activity measurements.

Through the well-established comparison systems of the International Reference System ({SIR}) at the Bureau International Des Poids et Mesures ({BIPM}) the {NMIs} can compare their national standards against those of other nations and show their equivalence and provide confidence in the standards being provided. Over the years many primary standards for radionuclides with applications in medicine have been developed and compared, with some of {PRISMAP} radionuclides already having been compared by {NMIs}. With many new radionuclides being proposed for nuclear medicine applications, there is still a substantial amount of work for the {NMIs} and the {BIPM} to perform to provide traceability.},
	author = {Collins, Sean},
	urldate = {2025-11-10},
	date = {2024-05-01},
	note = {Publisher: Zenodo},
	keywords = {deliverable},
}