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.

Todde, S., Windhorst, A., Behe, M., Bormans, G., Decristoforo, C., Faivre Chauvet, A., et al. (2014). EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD). EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING, 41, 2175-2185 [10.1007/s00259-014-2866-8].

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

TODDE, SERGIO CAMILLO;
2014

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.
Articolo in rivista - Articolo scientifico
Radiopharmaceutical; Clinical trial; Investigational medicinal product; Guideline
English
2014
41
2175
2185
none
Todde, S., Windhorst, A., Behe, M., Bormans, G., Decristoforo, C., Faivre Chauvet, A., et al. (2014). EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD). EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING, 41, 2175-2185 [10.1007/s00259-014-2866-8].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/53861
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