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EANM guideline for ...
EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)
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- Todde, Sergio (author)
- University of Milano Bicocca, Italy
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- Windhorst, Albert D. (author)
- Vrije University of Amsterdam, Netherlands
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- Behe, Martin (author)
- ETH PSI USZ, Switzerland
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- Bormans, Guy (author)
- Katholieke University of Leuven, Belgium
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- Decristoforo, Clemens (author)
- Medical University of Innsbruck, Austria
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- Faivre-Chauvet, Alain (author)
- CHU Nantes, France
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- Ferrari, Valentina (author)
- GE Healthcare, England
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- Gee, Antony D. (author)
- Kings Coll London, England
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- Gulyas, Balazs (author)
- Karolinska Institute, Sweden
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- Halldin, Christer (author)
- Karolinska Institutet
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- Kolenc Peitl, Petra (author)
- University of Medical Centre Ljubljana, Slovenia
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- Koziorowski, Jacek (author)
- Östergötlands Läns Landsting,Linköpings universitet,Avdelningen för radiologiska vetenskaper,Hälsouniversitetet,Radiofysikavdelningen US
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- Mindt, Thomas L. (author)
- University of Basel Hospital, Switzerland
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- Sollini, Martina (author)
- Arcispedale Santa Maria Nuova, Italy
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- Vercouillie, Johnny (author)
- University of Tours, France
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- Ballinger, James R. (author)
- Guys and St Thomas Hospital, England
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- Elsinga, Philip H. (author)
- University of Groningen, Netherlands
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(creator_code:org_t)
- 2014-08-01
- 2014
- English.
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In: European Journal of Nuclear Medicine and Molecular Imaging. - : Springer Verlag (Germany). - 1619-7070 .- 1619-7089. ; 41:11, s. 2175-2185
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Keyword
- Radiopharmaceutical; Clinical trial; Investigational medicinal product; Guideline
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Todde, Sergio
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Windhorst, Alber ...
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Behe, Martin
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Bormans, Guy
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Decristoforo, Cl ...
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Faivre-Chauvet, ...
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Ferrari, Valenti ...
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Gee, Antony D.
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Gulyas, Balazs
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Halldin, Christe ...
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Kolenc Peitl, Pe ...
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Koziorowski, Jac ...
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Mindt, Thomas L.
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Sollini, Martina
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Vercouillie, Joh ...
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Ballinger, James ...
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Elsinga, Philip ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
- Articles in the publication
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European Journal ...
- By the university
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Linköping University
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Karolinska Institutet