liu.seSearch for publications in DiVA
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • oxford
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)
University of Milano Bicocca, Italy.
Vrije University of Amsterdam, Netherlands.
ETH PSI USZ, Switzerland.
Katholieke University of Leuven, Belgium.
Show others and affiliations
2014 (English)In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 41, no 11, p. 2175-2185Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Springer Verlag (Germany) , 2014. Vol. 41, no 11, p. 2175-2185
Keywords [en]
Radiopharmaceutical; Clinical trial; Investigational medicinal product; Guideline
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:liu:diva-112171DOI: 10.1007/s00259-014-2866-8ISI: 000343051700028PubMedID: 25081821OAI: oai:DiVA.org:liu-112171DiVA, id: diva2:764281
Available from: 2014-11-18 Created: 2014-11-18 Last updated: 2017-12-05

Open Access in DiVA

No full text in DiVA

Other links

Publisher's full textPubMed

Authority records

Koziorowski, Jacek

Search in DiVA

By author/editor
Koziorowski, Jacek
By organisation
Division of Radiological SciencesFaculty of Health SciencesDepartment of Radiation Physics
In the same journal
European Journal of Nuclear Medicine and Molecular Imaging
Clinical Medicine

Search outside of DiVA

GoogleGoogle Scholar

doi
pubmed
urn-nbn

Altmetric score

doi
pubmed
urn-nbn
Total: 75 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • oxford
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf