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EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)

  • Sergio Todde
  • Albert D. Windhorst
  • Martin Behe
  • Guy Bormans
  • Clemens Decristoforo
  • Alain Faivre-Chauvet
  • Valentina Ferrari
  • Antony D. Gee
  • Balazs Gulyas
  • Christer Halldin
  • Petra Kolenc Peitl
  • Jacek Koziorowski
  • Thomas L. Mindt
  • Martina Sollini
  • Johnny Vercouillie
  • James R. Ballinger
  • Philip H. Elsinga
Guidelines

Abstract

The preparation of an Investigational Medicinal Product Dossier (IMPD) for a radiopharmaceutical to be used in a clinical trial is a challenging proposition for radiopharmaceutical scientists working in small-scale radiopharmacies. In addition to the vast quantity of information to be assembled, the structure of a standard IMPD is not well suited to the special characteristics of radiopharmaceuticals. This guideline aims to take radiopharmaceutical scientists through the practicalities of preparing an IMPD, in particular giving advice where the standard format is not suitable. Examples of generic IMPDs for three classes of radiopharmaceuticals are given: a small molecule, a kit-based diagnostic test and a therapeutic radiopharmaceutical.

Keywords

Radiopharmaceutical Clinical trial Investigational medicinal product Guideline 

Supplementary material

259_2014_2866_MOESM1_ESM.doc (470 kb)
Appendix 1 IMPD for [11C]choline (DOC 469 kb)
259_2014_2866_MOESM2_ESM.doc (570 kb)
Appendix 2 IMPD for [68Ga]DOTA-NOC (DOC 569 kb)
259_2014_2866_MOESM3_ESM.doc (351 kb)
Appendix 3 IMPD for [177Lu]DOTA-peptides (DOC 351 kb)

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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Sergio Todde
    • 2
  • Albert D. Windhorst
    • 3
  • Martin Behe
    • 4
  • Guy Bormans
    • 5
  • Clemens Decristoforo
    • 6
  • Alain Faivre-Chauvet
    • 7
  • Valentina Ferrari
    • 8
  • Antony D. Gee
    • 9
  • Balazs Gulyas
    • 10
  • Christer Halldin
    • 10
  • Petra Kolenc Peitl
    • 11
  • Jacek Koziorowski
    • 12
  • Thomas L. Mindt
    • 13
  • Martina Sollini
    • 14
  • Johnny Vercouillie
    • 15
  • James R. Ballinger
    • 16
  • Philip H. Elsinga
    • 1
    • 17
  1. 1.Nuclear Medicine and Molecular Imaging, University Medical Center GroningenUniversity of GroningenGroningenNetherlands
  2. 2.Fondazione TecnomedUniversità di Milano-BicoccaMonzaItaly
  3. 3.Department of Radiology & Nuclear MedicineVU University Medical CentreAmsterdamNetherlands
  4. 4.ETH-PSI-USZ Paul-Scherrer-InstituteVilligenSwitzerland
  5. 5.K.U. LeuvenLeuvenBelgium
  6. 6.Innsbruck Medical UniversityInnsbruckAustria
  7. 7.CHU de NantesNantesFrance
  8. 8.GE HealthcareAmershamUK
  9. 9.Division of Imaging SciencesKing’s College LondonLondonUK
  10. 10.Department of Clinical NeuroscienceKarolinska InstituteStockholmSweden
  11. 11.University Medical Centre LjubljanaLjubljanaSlovenia
  12. 12.UniversitetssjukhusetLinköpingSweden
  13. 13.University Hospital BaselBaselSwitzerland
  14. 14.Arcispedale Santa Maria NuovaReggio EmiliaItaly
  15. 15.University of ToursToursFrance
  16. 16.Guy’s and St Thomas’ HospitalLondonUK
  17. 17.University Medical Center GroningenUniversity of GroningenGroningenNetherlands

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