Abstract
Inclusion of radiopharmaceuticals into the family of medicinal products, and compliance with regulations thereof, has not been homogeneous worldwide, as the process has occurred with different chronologies and different strategies have been adopted across countries. However, general consensus has been reached on the medicinal nature of these products and on the notion that their use in humans must be done in compliance with enforced regulations. In some specific instances, such as during clinical investigations and when using non-approved radiopharmaceuticals, their application may be severely limited.
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Salvadori, P.A. (2019). Radiopharmacy/Radiochemistry for Positron-Emitting Radiopharmaceuticals, Including Quality Assurance and Process Validation Principles. In: Volterrani, D., Erba, P.A., Carrió, I., Strauss, H.W., Mariani, G. (eds) Nuclear Medicine Textbook. Springer, Cham. https://doi.org/10.1007/978-3-319-95564-3_40
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