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

doi:10.1007/s00259-014-2866-8

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

Research output: Contribution to journal › Article › peer-review

32 Citations (Scopus)

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.

Original language	English
Pages (from-to)	2175-2185
Number of pages	11
Journal	European Journal of Nuclear Medicine and Molecular Imaging
Volume	41
Issue number	11
DOIs	https://doi.org/10.1007/s00259-014-2866-8
Publication status	Published - 1 Nov 2014

Keywords

Clinical trial
Guideline
Investigational medicinal product
Radiopharmaceutical

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10.1007/s00259-014-2866-8

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Todde, S., Windhorst, A. D., Behe, M., Bormans, G., Decristoforo, C., Faivre-Chauvet, A., Ferrari, V., Gee, A. D., Gulyas, B., Halldin, C., Peitl, P. K., Koziorowski, J., Mindt, T. L., Sollini, M., Vercouillie, J., Ballinger, J. R., & Elsinga, P. H. (2014). EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD). European Journal of Nuclear Medicine and Molecular Imaging, 41(11), 2175-2185. https://doi.org/10.1007/s00259-014-2866-8

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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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Todde, S, Windhorst, AD, Behe, M, Bormans, G, Decristoforo, C, Faivre-Chauvet, A, Ferrari, V, Gee, AD, Gulyas, B, Halldin, C, Peitl, PK, Koziorowski, J, Mindt, TL, Sollini, M, Vercouillie, J, Ballinger, JR & Elsinga, PH 2014, 'EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)', European Journal of Nuclear Medicine and Molecular Imaging, vol. 41, no. 11, pp. 2175-2185. https://doi.org/10.1007/s00259-014-2866-8

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AU - Todde, Sergio

AU - Windhorst, Albert D.

AU - Behe, Martin

AU - Bormans, Guy

AU - Decristoforo, Clemens

AU - Faivre-Chauvet, Alain

AU - Ferrari, Valentina

AU - Gee, Antony D.

AU - Gulyas, Balazs

AU - Halldin, Christer

AU - Peitl, Petra Kolenc

AU - Koziorowski, Jacek

AU - Mindt, Thomas L.

AU - Sollini, Martina

AU - Vercouillie, Johnny

AU - Ballinger, James R.

AU - Elsinga, Philip H.

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KW - Guideline

KW - Investigational medicinal product

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JO - European Journal of Nuclear Medicine and Molecular Imaging

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ER -

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

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Keywords

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