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

• DOI: 10.1007/s00259-014-2866-8
• Publication Date: 2014-07-31T05:21:22Z
• 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
• Keywords: Guideline; Investigational Drugs

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.