Abstract
This chapter presents strategies and practical guidance for the development and early clinical translation of radiopharmaceuticals for oncology in the United States, particularly for non-commercial, academic sponsors. Process planning, preclinical safety evaluation, product quality, clinical design, regulatory mechanisms, and the investigational new drug application are discussed. The principles presented apply to small molecule or biological molecular imaging probes, theranostic platforms, and radiotherapeutics and focus on first-in-human studies. It is hoped that this overview will help academic investigators navigate the regulatory system efficiently and safely.
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Sequeira, S., Lyashchenko, S.K. (2019). The Clinical Translation Process in the United States. In: Lewis, J., Windhorst, A., Zeglis, B. (eds) Radiopharmaceutical Chemistry. Springer, Cham. https://doi.org/10.1007/978-3-319-98947-1_36
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DOI: https://doi.org/10.1007/978-3-319-98947-1_36
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