Non-clinical requirements for radiopharmaceuticals

November 22, 2018 – This new guideline is intended to provide guidance on the required non-clinical data to support clinical development and approval of radiopharmaceuticals. The document is intended to complement currently available guidelines (such as ICH M3(R2), ICH S6(R1), ICH S9 or the EMA guideline on “strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products” and includes the different intended … (leggi tutto)