Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU
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The purpose of this guideline is to help investigators by giving an overview of relevant current EU requirements concerning the quality of starting materials and final drug products (the radiopharmaceuticals), the non-clinical safety studies and dosimetry considerations whilst designing a human clinical trial which includes the use of radiopharmaceutical compounds.
KeywordsRadiopharmaceuticals Early phase Clinical trials Regulations Quality requirements Toxicology Dosimetry
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