Development and preparation of radiopharmaceuticals

Radiopharmaceuticals (RPs) are considered as drugs or Medicinal Products, either for diagnostic or therapeutic applications. Thus, RPs undergo a preclinical development phase needed to obtain the scientific and technical data to be submitted to the adequate drug-regulatory authorities for the clinical translation of novel products. This include chemical, radiochemical, pharmaceutical parameters required to guarantee the quality of the novel RPs. Additional tests in the proper cellular and animal models, often referred to as “non-clinical” or “preclinical”, are also mandatory to predict the expected in vivo behavior in humans, namely to address safety and efficacy issues. In this process, specific guidance is rare, reflecting the wide range of RPs applications that involve a vast variety of targets, different radionuclides requiring variable chemical approaches for the RPs design and a great range of clinical applications, from oncology to neurology.

During the development of novel RPs, pharmacokinetic, biodistribution, and dosimetry studies are usually performed under non-GLP conditions (GLP stands for Good Laboratory Practice). In contrast, non-clinical safety studies performed with the non-radioactive component, in particular toxicity studies, must run in GLP-certified laboratories. For their clinical translation, a radiopharmaceutical to be evaluated in clinical trials must be also obtained under Good Manufacture Practices (GMP), which is facilitated through the use of automated processes. In this context, GMP compliant processes should be considered in the preparation of RPs with the novel PRISMAP radionuclides, which can be inspired on processes and methods applied to prepare related and clinically approved RPs, namely radiometal-based RPs for which monographs are already available at the European Pharmacopeia (Ph. Eur.).

This portal provides information useful to guide radiopharmaceutical scientists, Nuclear Medicine specialists, and regulatory professionals to bring innovative diagnostic and therapeutic radiopharmaceuticals into the clinical evaluation, namely to elaborate the respective IMPD Investigational Medicinal Product Dossier (IMPD) containing data on the quality, production and control of the RP undergoing a clinical translation.