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

Eur J Nucl Med Mol Imaging. 2008 Nov;35(11):2144-51. doi: 10.1007/s00259-008-0853-7.


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.

Publication types

  • Practice Guideline

MeSH terms

  • Clinical Trials as Topic / standards*
  • European Union
  • Fluorodeoxyglucose F18 / adverse effects
  • Fluorodeoxyglucose F18 / therapeutic use
  • Humans
  • Radiometry
  • Radiopharmaceuticals / adverse effects
  • Radiopharmaceuticals / standards*
  • Radiopharmaceuticals / therapeutic use
  • Technetium Tc 99m Medronate / adverse effects
  • Technetium Tc 99m Medronate / therapeutic use


  • Radiopharmaceuticals
  • Fluorodeoxyglucose F18
  • Technetium Tc 99m Medronate