Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals.

Background: The 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.

λ-Eye: a high-sensitivity γ imaging probe for axillary sentinel lymph node mapping.

Objective: The aim of this study is the construction and performance evaluation of 'λ-eye', a γ imaging probe, optimized in terms of sensitivity for sentinel lymph node mapping. The optimization of the probe is based on theoretical models and simulation results that were presented in a previous study of our group. In this work, the construction of the probe, the experimental confirmation of the simulation results, and the evaluation of its performance with phantoms and lymph node imaging in small animals are presented.