ReviewEJNMMI radiopharmacy and chemistry2022
Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals.
Review in EJNMMI radiopharmacy and chemistry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled 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.
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
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.
- Utility of Preclinical Dosimetry for First-in-Human Studies with PET Drugs Labeled with Common Radionuclides: A Systematic Review of Radiation Dose Estimates.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026Pooled it
- Specific PET Imaging for Precision Management of Lung Cancer: Advances, Clinical Translation and Future Directions.Chemical & biomedical imaging · 2026Review
- Enhancement of Gut Microbial Homeostasis by a Post-NGPNutrients · 2026Article
- Pulmonary Drug Delivery in the Era of Nanomedicine: From Biological Barriers to Artificial Intelligence-Driven Optimization.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Clinical nuclear medicine applications of zirconium-89 immuno-PET: a comprehensive review from a radiopharmaceutical perspective.EJNMMI radiopharmacy and chemistry · 2026Review
- Tumour Microenvironment-Informed Radiotheranostics: Why and How Nuclear Medicine Could Advance Precision Oncology in the Decade Ahead.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Radiopharmaceuticals: Status, Regulatory Landscape and Future Perspective.AAPS PharmSciTech · 2026Review
- Astatine-211-Towards In Vivo Stable Astatine-211 Labeled Radiopharmaceuticals and Their (Pre)Clinical Applications.Medicinal research reviews · 2026Review
- Theranostics in nuclear medicine: the era of precision oncology.Medical oncology (Northwood, London, England) · 2025Review
- Radiopharmaceutical formulation and preliminary clinical dosimetry of [European journal of nuclear medicine and molecular imaging · 2025Article
- Translation of PET radiotracers for cancer imaging: recommendations from the National Cancer Imaging Translational Accelerator (NCITA) consensus meeting.BMC medicine · 2025Article
- Automated Production of [Pharmaceutics · 2024Article
- Production and regulatory issues for theranostics.The Lancet. Oncology · 2024Review
- EANM guidance document: dosimetry for first-in-human studies and early phase clinical trials.European journal of nuclear medicine and molecular imaging · 2024Article
- Position paper to facilitate patient access to radiopharmaceuticals: considerations for a suitable pharmaceutical regulatory framework.EJNMMI radiopharmacy and chemistry · 2024Article
- Aspects and prospects of preclinical theranostic radiopharmaceutical development.Theranostics · 2024Review
- Proceedings of international symposium of trends in radiopharmaceuticals 2023 (ISTR-2023).EJNMMI radiopharmacy and chemistry · 2023Review
- Radiolabeled Human Serum Albumin Nanoparticles Co-Loaded with Methotrexate and Decorated with Trastuzumab for Breast Cancer Diagnosis.Journal of functional biomaterials · 2023Article
- From bench to bedside:EJNMMI research · 2023Article
- Highlight selection of radiochemistry and radiopharmacy developments by editorial board.EJNMMI radiopharmacy and chemistry · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 15 institutions in 12 countries.
Funding
Abstract
backgroundThe development of radiopharmaceuticals requires extensive evaluation before they can be applied in a diagnostic or therapeutic setting in Nuclear Medicine. Chemical, radiochemical, and pharmaceutical parameters must be established and verified to ensure the quality of these novel products. MAIN BODY: To provide supportive evidence for the expected human in vivo behaviour, particularly related to safety and efficacy, additional tests, often referred to as "non-clinical" or "preclinical" are mandatory. This document is an outcome of a Technical Meeting of the International Atomic Energy Agency. It summarises the considerations necessary for non-clinical studies to accommodate the regulatory requirements for clinical translation of radiopharmaceuticals. These considerations include non-clinical pharmacology, radiation exposure and effects, toxicological studies, pharmacokinetic modelling, and imaging studies. Additionally, standardisation of different specific clinical applications is discussed.
conclusionThis document is intended as a guide for radiopharmaceutical scientists, Nuclear Medicine specialists, and regulatory professionals to bring innovative diagnostic and therapeutic radiopharmaceuticals into the clinical evaluation process in a safe and effective way.
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.