Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU

    loading  Checking for direct PDF access through Ovid


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.

    loading  Loading Related Articles