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

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

doi:10.1007/s00259-014-2866-8

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

Author:

Todde, Sergio

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

Keywords:

Science & Technology, Life Sciences & Biomedicine, Radiology, Nuclear Medicine & Medical Imaging, Radiopharmaceutical, Clinical trial, Investigational medicinal product, Guideline, Clinical Trials as Topic, Drug Stability, Government Regulation, Nuclear Medicine, Quality Control, Radiopharmaceuticals, Reference Standards, Societies, Scientific, Terminology as Topic, 0299 Other Physical Sciences, 1103 Clinical Sciences, Nuclear Medicine & Medical Imaging

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.