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

  • Alfons VerbruggenEmail author
  • Heinz H. Coenen
  • Jean-Robert Deverre
  • Denis Guilloteau
  • Bengt Langstrom
  • Piero A. Salvadori
  • Christer Halldin
Guidelines

Abstract

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.

Keywords

Radiopharmaceuticals Early phase Clinical trials Regulations Quality requirements Toxicology Dosimetry 

References

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Copyright information

© EANM 2008

Authors and Affiliations

  • Alfons Verbruggen
    • 1
    Email author
  • Heinz H. Coenen
    • 2
  • Jean-Robert Deverre
    • 3
  • Denis Guilloteau
    • 4
  • Bengt Langstrom
    • 5
  • Piero A. Salvadori
    • 6
  • Christer Halldin
    • 7
  1. 1.Laboratory of RadiopharmacyLeuvenBelgium
  2. 2.Institut für Neurowissenschaften und Biophysik INB-4 (Nuklearchemie) Forschungszentrum JülichJülichGermany
  3. 3.CEA Service Hospitalier Frédéric JoliotOrsayFrance
  4. 4.INSERM Unité 619 CHRU de Tours, Université François-Rabelais de ToursToursFrance
  5. 5.Radiopharmaceutisk organisk kemi, UPPSALA UNIVERSITET, Institutionen för biokemi och organisk kemiUppsalaSweden
  6. 6.Radiopharmaceutical Chemistry DepartmentCNR Institute of Clinical PhysiologyPisaItaly
  7. 7.Karolinska Institutet, Department of Clinical NeuroscienceStockholmSweden

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