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Radiopharmaceuticals have been widely used in many clinical and nonclinical applications, such as in vivo and non-invasive diagnosis or treatment of human diseases. The quality of radiopharmaceuticals administered for a patient is primarily related for the radiation dose delivered to achieve optimizing diagnostic imaging or therapeutic efficacy. Radiopharmaceut‐ icals with different half-lives (short, medium, and long), decay modes (alpha, beta, gamma, and electron capture), and biochemical properties (of ligands) can determine their utilities in medicine. Moreover, chemical and radiochemical impurities in a radiopharmaceutical can produce a serious trouble of diagnosis or treatment. Therefore, different requirements, regu‐ lations, and instrumentations for ensuring their high quality and high safety have been devel‐ oped in many countries.

Quality by Design and Risk Assessment for Radiopharmaceutical Manufacturing and Clinical Imaging