Evidence map›Paper›PMID 40637991›Full record

ArticleEJNMMI radiopharmacy and chemistry2025

To be GMP or not to be- a radionuclide's question.

Clemens Decristoforo, Renata Mikolajczak, Clive Naidoo, Suzanne Lapi, Ferid Haddad, David Emmanuel Schmid, Lurdes Gano, Ulli Köster, Thierry Stora

Abstract read
In one paragraph

Article in EJNMMI radiopharmacy and chemistry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Pharmaceuticals (Basel, Switzerland) · 2026
    Review
  3. Article
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

9 authors.

Clemens DecristoforoDepartment of Nuclear Medicine, Medical University Innsbruck, Anichstrasse 35, Innsbruck, A-6020, Austria. Clemens.Decristoforo@i-med.ac.at.ORCID http://orcid.org/0000-0003-0566-4036
Renata MikolajczakRadioisotope Centre POLATOM, National Centre for Nuclear Research, Otwock, Poland.
Clive NaidooHevesy Laboratory, DTU Health Technology, Technical University Denmark, Roskilde, Denmark.
Suzanne LapiDepartment of Radiology, University of Alabama at Birmingham, Birmingham, AL, USA.
Ferid HaddadGIP ARRONAX, Saint Herblain, France.
David Emmanuel SchmidCenter for Radiopharmaceuticals Sciences, PSI Center for Life Sciences, Villigen, Switzerland.
Lurdes GanoCentro de Ciências e Tecnologias Nucleares, Instituto Superior Técnico, Universidade de Lisboa, Campus Tecnológico e Nuclear, Lissabon, Portugal.
Ulli KösterInstitut Laue-Langevin, Grenoble, France.
Thierry StoraCERN, Geneva, Switzerland.

Funding

H2020 Research Infrastructures 101008571Innovative Health Initiative 101173001
6 · The paper itself

Abstract

backgroundRadionuclides are the essential component of radiopharmaceuticals, their production needs to consider pharmaceutical regulations and guidelines, also for clinical research applications. MAIN BODY: In this paper we reflect on the pharmaceutical regulatory landscape for radionuclide production in Europe, with a focus on Good Manufacturing Practices (GMP). The challenges for novel production pathways and the pathways for non-GMP production of radionuclides are discussed.

conclusionIn particular when radionuclides are used as starting materials, exemptions from GMP requirements are essential for clinical innovation and a common understanding is needed to enable the safe use of novel radionuclides for medical applications without unnecessary regulatory hurdles for the user.

Indexed as

EMAGMPPharmaceutical regulationsRadionuclidesRadiopharmaceuticals

Identifiers

PMID40637991
PMCPMC12246291

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.