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The Clinical Translation Process in Europe

  • Iván Peñuelas
  • Philip H. ElsingaEmail author
Chapter

Abstract

This chapter describes the process of bringing radiopharmaceuticals from preclinical investigations to first-in-man studies, specifically the first application of a new radiopharmaceutical in an imaging study in humans aiming to demonstrate the potential of the radiotracer to image a specific molecular target. This translational trajectory – often called moving “from bench to bedside” – includes several steps that require attention to specific regulations. As these regulations differ throughout the world, we will focus on the current situation in Europe. This chapter will focus on the philosophy developed in the European Union by European agencies and associations – for example, the European Medicines Agency (EMA) and the European Pharmacopoeia (Ph. Eur.) – as well as societies such as the European Association of Nuclear Medicine (EANM).

Keywords

Clinical translation Investigational Medicinal Product Dossier (IMPD) Good manufacturing practice (GMP) Good clinical practice (GCP) Radiopharmaceutical Toxicity Legislation Clinical trial 

References

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    Koziorowski J, Behe M, Decristoforo C, Ballinger J, Elsinga PH, Ferrari V, et al. Position paper on requirements for toxicological studies in the specific case of radiopharmaceuticals. EJNMMI Radiopharm Chem. 2016;1:1.CrossRefGoogle Scholar
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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Unidad de Radiofarmacia, Clinica Universidad de NavarraPamplonaSpain
  2. 2.Department of Nuclear Medicine and Molecular ImagingUniversity Medical Center Groningen, University of GroningenGroningenThe Netherlands
  3. 3.Faculty of Medical SciencesUniversity of GroningenGroningenThe Netherlands

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