Evidence map›Paper›PMID 38165504›Full record

ArticleEJNMMI radiopharmacy and chemistry2024

Position paper to facilitate patient access to radiopharmaceuticals: considerations for a suitable pharmaceutical regulatory framework.

Aruna Korde, Marianne Patt, Svetlana V Selivanova, Andrew M Scott, Rolf Hesselmann, Oliver Kiss, Natesan Ramamoorthy, Sergio Todde, Sietske M Rubow, Luther Gwaza and 5 more

Abstract read
In one paragraph

Article in EJNMMI radiopharmacy and chemistry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

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  6. Pharmaceuticals (Basel, Switzerland) · 2026
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  15. Automated radiolabelling of [EJNMMI radiopharmacy and chemistry · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Aruna KordeDivision of Physical and Chemical Sciences, Department of Nuclear Sciences and Applications, International Atomic Energy Agency, Vienna, Austria.
Marianne PattSection Radiopharmacy, Department of Nuclear Medicine, University Hospital Augsburg, Augsburg, Germany.
Svetlana V SelivanovaCanadian Nuclear Laboratories, Chalk River, ON, Canada.
Andrew M ScottDepartment of Molecular Imaging and Therapy, Austin Health, and Faculty of Medicine, University of Melbourne, Melbourne, Australia.
Rolf HesselmannHealth Protection Directorate, Radiation Protection Division, Section for Research Facilities and Nuclear Medicine, Federal Office of Public Health, Bern, Switzerland.
Oliver KissDepartment of Targetry, Target Chemistry and Radiopharmacy, Institute for Radipopharmaceutical Cancer Research, Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany.
Natesan RamamoorthyNational Institute of Advanced Studies (NIAS), Bangalore, 560012, India.
Sergio ToddeDepartment of Medicine and Surgery, University of Milano-Bicocca, Tecnomed Foundation, Via Pergolesi, 33, 20900, Monza, Italy.
Sietske M RubowFaculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Luther GwazaHealth Products Policy and Standards Department, World Health Organization, Geneva, Switzerland.
Serge LyashchenkoDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Jan AnderssonEdmonton Radiopharmaceutical Centre, Alberta Health Services, Edmonton, Canada.
Brian HockleyDivision of Nuclear Medicine, Department of Radiology, University of Michigan, Ann Arbor, MI, USA.
Ravindra KaslivalOffice of New Drug Products, Office of Pharmaceutical Quality, CDER, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Clemens DecristoforoDepartment of Nuclear Medicine, Medical University Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria. clemens.decristoforo@i-med.ac.at.ORCID http://orcid.org/0000-0003-0566-4036

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748World Health Organization 001
6 · The paper itself

Abstract

backgroundNuclear medicine has made enormous progress in the past decades. However, there are still significant inequalities in patient access among different countries, which could be mitigated by improving access to and availability of radiopharmaceuticals. MAIN BODY: This paper summarises major considerations for a suitable pharmaceutical regulatory framework to facilitate patient access to radiopharmaceuticals. These include the distinct characteristics of radiopharmaceuticals which require dedicated regulations, considering the impact of the variable complexity of radiopharmaceutical preparation, personnel requirements, manufacturing practices and quality assurance, regulatory authority interfaces, communication and training, as well as marketing authorisation procedures to ensure availability of radiopharmaceuticals. Finally, domestic and regional supply to ensure patient access via alternative regulatory pathways, including in-house production of radiopharmaceuticals, is described, and an outlook on regulatory challenges faced by new developments, such as the use of alpha emitters, is provided.

conclusionsAll these considerations are an outcome of a dedicated Technical Meeting organised by the IAEA in 2023 and represent the views and opinions of experts in the field, not those of any regulatory authorities.

Indexed as

GMPLegislationMarketing authorisationRadiopharmaceuticalRegulationsRegulatory framework

Identifiers

PMID38165504
PMCPMC10761641

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.