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

Authors :: 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
Source :: European journal of nuclear medicine and molecular imaging [Eur J Nucl Med Mol Imaging] 2014 Nov; Vol. 41 (11), pp. 2175-85.
Publication Year :: 2014
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.

Subjects :: Clinical Trials as Topic
Drug Stability
Government Regulation
Quality Control
Reference Standards
Terminology as Topic
Nuclear Medicine legislation & jurisprudence
Nuclear Medicine standards
Radiopharmaceuticals therapeutic use
Societies, Scientific

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