ArticleEJNMMI radiopharmacy and chemistry2017
Position paper on requirements for toxicological studies in the specific case of radiopharmaceuticals.
Article in EJNMMI radiopharmacy and chemistry, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 22 papers.
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.
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.
Who cites it
22 citing papers in PubMed, 44 citations in OpenAlex.
- Radiopharmaceuticals: Status, Regulatory Landscape and Future Perspective.AAPS PharmSciTech · 2026Review
- Acute radiotoxicity studies and safety assessment ofScientific reports · 2025Article
- Nonclinical investigations of a novel heart-type fatty acid-binding protein ligand, [EJNMMI radiopharmacy and chemistry · 2025Article
- Toxicity study of TEoS-DAZA, a chemical precursor for functional liver imaging with PET/CT.EJNMMI radiopharmacy and chemistry · 2025Article
- Preclinical safety and effectiveness of a long-acting somatostatin analogue [European journal of nuclear medicine and molecular imaging · 2025Article
- Process validation and preclinical development of a new PET cerebral blood flow tracer [EJNMMI radiopharmacy and chemistry · 2024Article
- Preclinical validation of a novel brain-penetrant PET ligand for visualization of histone deacetylase 6: a potential imaging target for neurodegenerative diseases.European journal of nuclear medicine and molecular imaging · 2024Article
- Can current preclinical strategies for radiopharmaceutical development meet the needs of targeted alpha therapy?European journal of nuclear medicine and molecular imaging · 2024Review
- Radiometal chelators for infection diagnostics.Frontiers in nuclear medicine · 2023Article
- Future Prospective of Radiopharmaceuticals from Natural Compounds Using Iodine Radioisotopes as Theranostic Agents.Molecules (Basel, Switzerland) · 2022Review
- Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals.EJNMMI radiopharmacy and chemistry · 2022Review
- multi-patient dose synthesis of [18F]Flumazenil via a copper-mediatedEJNMMI radiopharmacy and chemistry · 2022Article
- Radiopharmaceutical good practices: Regulation between hospital and industry.Frontiers in nuclear medicine · 2022Article
- Emerging Radionuclides in a Regulatory Framework for Medicinal Products - How Do They Fit?Frontiers in medicine · 2021Review
- Beta Cell Imaging-From Pre-Clinical Validation to First in Man Testing.International journal of molecular sciences · 2020Review
- Automated synthesis, preclinical toxicity, and radiation dosimetry of [EJNMMI research · 2020Article
- Clinical translation of theranostic radiopharmaceuticals: Current regulatory status and recent examples.Journal of labelled compounds & radiopharmaceuticals · 2019Review
- US and EU radiopharmaceutical diagnostic and therapeutic nonclinical study requirements for clinical trials authorizations and marketing authorizations.EJNMMI radiopharmacy and chemistry · 2019Article
- Erratum: Publisher Correction toEJNMMI radiopharmacy and chemistry · 2018Article
- Adventures in radiosynthesis of clinical grade [RSC advances · 2018Article
Corrections and comments
- Erratum issued
Authors and funding
9 authors at 9 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This is a position paper of the Radiopharmacy Committee of the EANM (European Association of Nuclear Medicine) addressing toxicology studies for application of new diagnostic and therapeutic radiopharmaceuticals (RP) that are not approved (i.e., not having a marketing authorization or a monograph in the European Pharmacopoeia), excluding endogenous and ubiquitous substances in humans. This paper discusses the requirements for clinical trials with radiopharmaceuticals for clinical research applications, not necessarily intended to aim at a marketing authorization. If marketing authorization is intended, scientific advice of the competent authorities is mandatory and cannot be replaced by this position paper. The position paper reflects the view of the Radiopharmacy Committee of the EANM and can be used as a basis for discussions with the responsible authorities.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.