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Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU
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2008 (English)In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 35, no 11, 2144-2151 p.Article in journal (Refereed) Published
Abstract [en]

The purpose of this guideline is to help investigators by giving an overview of relevant current EU requirements concerning the quality of starting materials and final drug products (the radiopharmaceuticals), the non-clinical safety studies and dosimetry considerations whilst designing a human clinical trial which includes the use of radiopharmaceutical compounds.

Place, publisher, year, edition, pages
2008. Vol. 35, no 11, 2144-2151 p.
Keyword [en]
Radiopharmaceuticals, Early phase, Clinical trials, Regulations, Quality requirements, Toxicology, Dosimetry
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-107865DOI: 10.1007/s00259-008-0853-7ISI: 000259909600026OAI: oai:DiVA.org:uu-107865DiVA: diva2:233355
Available from: 2009-08-31 Created: 2009-08-31 Last updated: 2017-12-13Bibliographically approved

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Department of Biochemistry and Organic Chemistry
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European Journal of Nuclear Medicine and Molecular Imaging
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