ArticleEJNMMI radiopharmacy and chemistry2019
US and EU radiopharmaceutical diagnostic and therapeutic nonclinical study requirements for clinical trials authorizations and marketing authorizations.
Article in EJNMMI radiopharmacy and chemistry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 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
6 citing papers in PubMed.
- Review
- Astatine-211-Towards In Vivo Stable Astatine-211 Labeled Radiopharmaceuticals and Their (Pre)Clinical Applications.Medicinal research reviews · 2026Review
- Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals.EJNMMI radiopharmacy and chemistry · 2022Review
- 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
- Use of 55 PET radiotracers under approval of a Radioactive Drug Research Committee (RDRC).EJNMMI radiopharmacy and chemistry · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
New regulatory guidance documents from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recently been finalized or are in draft format outlining new pathways for preclinical safety testing. The US and the European Union appear to be moving in a similar direction focussing and refining preclinical safety data requirements for both radiodiagnostics and radiotherapeutics. We here summarize these recent documents from both the US and European perspective.
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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.