Issue Date: November 28, 2011
Issued by: Center for Drug Evaluation and Research
Topic(s): Pharmacology/Toxicology
Status: Final
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. Because there are other guidances available for conventional nonclinical safety studies, this guidance focuses solely on late radiation safety concerns that are unique to therapeutic radiopharmaceuticals. These unique safety concerns result from the risk of irreversible late radiation toxicity when these agents deliver high doses of ionizing radiation to normal organs.
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