ArticleAmerican journal of nuclear medicine and molecular imaging2025
Streamlining first-in-human PET radiopharmaceutical development: FDA's evolving stance on preclinical dosimetry.
Article in American journal of nuclear medicine and molecular imaging, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Visualizing T-cell activation: PET imaging of CXCL9 as a window into the tumor immune response.American journal of nuclear medicine and molecular imaging · 2025Article
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
Abstract
The U.S. Food and Drug Administration (FDA) has proposed a regulatory shift in the early-phase development of positron emission tomography (PET) radiopharmaceuticals, specifically regarding the requirement for animal-based dosimetry in first-in-human (FIH) studies. This editorial discusses the implications of the FDA's recent Advisory Committee briefing, which supports the omission of preclinical dosimetry under defined conditions for radiopharmaceuticals labeled with
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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.