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EJNMMI Radiopharmacy and Chemistry
Fig. 1 | EJNMMI Radiopharmacy and Chemistry

Fig. 1

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

Fig. 1

Clinical translation of radiopharmaceuticals: the development of a radiopharmaceutical requires many steps to finally be available for clinical use as a medicinal product, starting from the production of the radionuclide and precursor, thenradiochemical development to the biological characterization, pharmaceutical formulation and human studies within clinical trials. Data need to be generated regarding the chemical and pharmaceutical quality “Quality data”, but also data to predict safety and efficacy before human applications. These non-clinical data cover pharmacology, radiation effects and toxicology

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