Radiopharmaceuticals are special, but is this recognized? The possible impact of the new Clinical Trials Regulation on the preparation of radiopharmaceuticals

Nuclear medicine techniques are in the forefront of molecular imaging, thereby translating discoveries in molecular biology, genetics, pharmacology and many other disciplines into imaging diseases for the patients benefit. A wide variety of radiopharmaceuticals for many different targets are availab...

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Published inEuropean journal of nuclear medicine and molecular imaging Vol. 41; no. 11; pp. 2005 - 2007
Main Authors Decristoforo, C., Penuelas, I., Elsinga, P., Ballinger, J., Winhorst, A. D., Verbruggen, A., Verzijlbergen, F., Chiti, A.
Format Journal Article
LanguageEnglish
Published Berlin/Heidelberg Springer Berlin Heidelberg 01.11.2014
Springer Nature B.V
Subjects
Cardiology
Clinical trials
Clinical Trials as Topic
Drug Compounding
Editorial
EU directives
Humans
Imaging
Medicine
Medicine & Public Health
Nuclear Medicine
Oncology
Orthopedics
Pharmaceuticals
Radiology
Radiopharmaceuticals
Social Control, Formal
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Summary:Nuclear medicine techniques are in the forefront of molecular imaging, thereby translating discoveries in molecular biology, genetics, pharmacology and many other disciplines into imaging diseases for the patients benefit. A wide variety of radiopharmaceuticals for many different targets are available and many others are continually being developed. Over the past decade the major hurdle in translating this radiopharmaceutical development into the clinic has been an excessive and ever tightening regulatory framework for pharmaceuticals in general, which does not take into account the special nature of radiopharmaceuticals.
Bibliography:SourceType-Other Sources-1
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ObjectType-Editorial-2
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ISSN:1619-7070
1619-7089
DOI:10.1007/s00259-014-2838-z