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1.
  • Aerts, Joel, et al. (författare)
  • Guidance on current good radiopharmacy practice for the small-scale preparation of radiopharmaceuticals using automated modules : a European perspective
  • 2014
  • Ingår i: Journal of labelled compounds & radiopharmaceuticals. - : Wiley-Blackwell. - 0362-4803 .- 1099-1344. ; 57:10, s. 615-620
  • Tidskriftsartikel (refereegranskat)abstract
    • This document is meant to complement Part B of the EANM Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals issued by the Radiopharmacy Committee of the European Association of Nuclear Medicine, covering small-scale in-house preparation of radiopharmaceuticals with automated modules. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of radiopharmaceuticals, which are not intended for commercial purposes or distribution.
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2.
  • Todde, Sergio, et al. (författare)
  • EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)
  • 2014
  • Ingår i: European Journal of Nuclear Medicine and Molecular Imaging. - : Springer Verlag (Germany). - 1619-7070 .- 1619-7089. ; 41:11, s. 2175-2185
  • Tidskriftsartikel (refereegranskat)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.
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