Table 3 Guideline documents on radiopharmaceuticals from professional organizations
Guideline/text | Origin/organization | Topic | References |
|---|---|---|---|
Position paper on requirements for toxicological studies in the specific case of radiopharmaceuticals | EANM | Toxicity studies | Koziorowski et al. (2017) |
EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD) | EANM | Guideline for chemical and pharmaceutical part of an IMPD for radiopharmaceuticals | Todde et al. (2014) |
Guidelines to PET measurements of the target occupancy in the brain for drug development | EANM | PET occupancy study | Takano et al. (2016) |
Guidance for preclinical studies with radiopharmaceuticals | IAEA | Technical consideration for in vitro and in vivo preclinical evaluation of radiopharmaceuticals | Guidance for preclinical studies with radiopharmaceuticals. IAEA radioisotopes and radiopharmaceuticals series (2021) |
Acceptance testing for nuclear medicine instrumentation | EANM | Primarily for instrumentation in the clinics, but some instrumentation is also used in non-clinical setting | Busemann Sokole et al. (2010) |
IAEA-TECDOC-1782 Good practice for introducing radiopharmaceuticals for clinical use | IAEA | Partly related to IMP/IMD dossier and nonclinical testing | International Atomic Energy Agency (2016) |
International Atomic Energy Agency and World Health Organization guideline on good manufacturing practices for radiopharmaceutical products | IAEA | International GMP guidelines or radiopharmaceuticals | Annex 2 International Atomic Energy Agency and World Health Organization guideline on good manufacturing practices for radiopharmaceutical product [Internet]. WHO Technical Report Series (1025)(2020) |