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European Journal of Nuclear Medicine and Molecular Imaging

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01-11-2014 | Guidelines

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

Authors: 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

Published in: European Journal of Nuclear Medicine and Molecular Imaging | Issue 11/2014

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.

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Title: EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)
Authors: 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
Publication date: 01-11-2014
Publisher: Springer Berlin Heidelberg
Published in: European Journal of Nuclear Medicine and Molecular Imaging / Issue 11/2014
Print ISSN: 1619-7070
Electronic ISSN: 1619-7089
DOI: https://doi.org/10.1007/s00259-014-2866-8

At a glance: The STEP trials

Springer Medicine

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

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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