FDA: Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals

The objective of this guidance is to provide recommendations to industry for designing nonclinical late radiation toxicity studies to determine potential late radiation effects of therapeutic radiopharmaceutical agents. The purpose of conducting nonclinical late radiation toxicity studies is to help minimize the risk of late-occurring radiation toxicities in clinical trials of therapeutic radiopharmaceuticals.

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