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

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European Journal of Nuclear Medicine and Molecular Imaging Aims and scope Submit manuscript

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.

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Author information

Authors and Affiliations

  1. Laboratory of Radiopharmacy, Onderwijs en Navorsing 2, Box 821, Herestraat 49, 3000, Leuven, Belgium

    Alfons Verbruggen

  2. Institut für Neurowissenschaften und Biophysik INB-4 (Nuklearchemie) Forschungszentrum Jülich, 52425, Jülich, Germany

    Heinz H. Coenen

  3. CEA Service Hospitalier Frédéric Joliot, Orsay, France

    Jean-Robert Deverre

  4. INSERM Unité 619 CHRU de Tours, Université François-Rabelais de Tours, Tours, France

    Denis Guilloteau

  5. Radiopharmaceutisk organisk kemi, UPPSALA UNIVERSITET, Institutionen för biokemi och organisk kemi, Uppsala, Sweden

    Bengt Langstrom

  6. Radiopharmaceutical Chemistry Department, CNR Institute of Clinical Physiology, Pisa, Italy

    Piero A. Salvadori

  7. Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden

    Christer Halldin

Authors
  1. Alfons Verbruggen
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  2. Heinz H. Coenen
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  3. Jean-Robert Deverre
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  4. Denis Guilloteau
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  5. Bengt Langstrom
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  6. Piero A. Salvadori
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  7. Christer Halldin
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Corresponding author

Correspondence to Alfons Verbruggen.

Additional information

Under the auspices of the Drug Development Committee of the European Association of Nuclear Medicine.

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Verbruggen, A., Coenen, H.H., Deverre, JR. et al. Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU. Eur J Nucl Med Mol Imaging 35, 2144–2151 (2008). https://doi.org/10.1007/s00259-008-0853-7

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  • DOI: https://doi.org/10.1007/s00259-008-0853-7

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