Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

This review article examines the development of radiopharmaceutical imaging agents and radioligand therapies for pediatric patients, highlighting their important role in diagnosing and treating conditions such as cancer, infections, and neurological disorders. It emphasizes that nuclear medicine enables earlier and more precise diagnosis by assessing both organ function and structure, which is particularly valuable in children with nonspecific symptoms. However, pediatric development presents unique challenges, including ethical considerations, limited clinical data, physiological differences requiring tailored dosing, and regulatory complexities. The paper outlines current strategies for pediatric dose selection, including dosimetry modeling and consensus guidelines, and discusses regulatory frameworks from agencies like the FDA and EMA, along with requirements such as pediatric investigation plans. Overall, it underscores the need for optimized dosing, innovative trial designs, and model-informed approaches to advance safe and effective radiopharmaceutical development for children.