Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals.
Aruna KordeRenata MikolajczakPetra KolencPenelope BouziotisHadis WestinMette LauritzenMichel KooleMatthias Manfred HerthManuel BardièsAndre F MartinsAntonio PauloSerge K LyashchenkoSergio ToddeSangram NagEfthimis LamprouAntero AbrunhosaFrancesco GiammarileClemens DecristoforoPublished in: EJNMMI radiopharmacy and chemistry (2022)
This document is intended as a guide for radiopharmaceutical scientists, Nuclear Medicine specialists, and regulatory professionals to bring innovative diagnostic and therapeutic radiopharmaceuticals into the clinical evaluation process in a safe and effective way.