Non-clinical requirements for radiopharmaceuticals

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 uses of radiopharmaceuticals including radiodiagnostics as well as radiotherapeutics. The new guideline is focusing on opportunities to targeted non-clinical programs according to specific development settings and product types and is not intended to duplicate guidance related to dosimetry.

Keywords: Radiopharmaceuticals, radiodiagnostics, radiotherapeutics, non-clinical safety assessment

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