title: EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD).
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.
authors.affiliation: Fondazione Tecnomed, Università di Milano-Bicocca, Monza, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Todde
authors.forename: Albert D
authors.initials: AD
authors.lastname: Windhorst
authors.forename: Martin
authors.initials: M
authors.lastname: Behe
authors.forename: Guy
authors.initials: G
authors.lastname: Bormans
authors.forename: Clemens
authors.initials: C
authors.lastname: Decristoforo
authors.forename: Alain
authors.initials: A
authors.lastname: Faivre-Chauvet
authors.forename: Valentina
authors.initials: V
authors.lastname: Ferrari
authors.forename: Antony D
authors.initials: AD
authors.lastname: Gee
authors.forename: Balazs
authors.initials: B
authors.lastname: Gulyas
authors.forename: Christer
authors.initials: C
authors.lastname: Halldin
authors.forename: Petra Kolenc
authors.initials: PK
authors.lastname: Peitl
authors.forename: Jacek
authors.initials: J
authors.lastname: Koziorowski
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Mindt
authors.forename: Martina
authors.initials: M
authors.lastname: Sollini
authors.forename: Johnny
authors.initials: J
authors.lastname: Vercouillie
authors.forename: James R
authors.initials: JR
authors.lastname: Ballinger
authors.forename: Philip H
authors.initials: PH
authors.lastname: Elsinga
mesh_terms: D002986:Clinical Trials as Topic; D004355:Drug Stability; D033161:Government Regulation; D009683:Nuclear Medicine / Q000331:legislation & jurisprudence / Q000592:standards; D011786:Quality Control; D019275:Radiopharmaceuticals / Q000627:therapeutic use*; D012015:Reference Standards; D012958:Societies, Scientific; D009626:Terminology as Topic
chemical_list: D019275:Radiopharmaceuticals
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