TY - JOUR
T1 - EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)
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.
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Guideline
KW - Investigational medicinal product
KW - Radiopharmaceutical
UR - http://www.scopus.com/inward/record.url?scp=84925429920&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84925429920&partnerID=8YFLogxK
U2 - 10.1007/s00259-014-2866-8
DO - 10.1007/s00259-014-2866-8
M3 - Article
C2 - 25081821
AN - SCOPUS:84925429920
VL - 41
SP - 2175
EP - 2185
JO - European Journal of Pediatrics
JF - European Journal of Pediatrics
SN - 0340-6199
IS - 11
ER -