期刊
JOURNAL OF LABELLED COMPOUNDS & RADIOPHARMACEUTICALS
卷 62, 期 10, 页码 673-683出版社
WILEY
DOI: 10.1002/jlcr.3712
关键词
In-111-CP04; clinical trial; peptide radiopharmaceuticals; regulatory framework; theranostics nuclear medicine
资金
- Austrian Science Fund (FWF) [I1224] Funding Source: Austrian Science Fund (FWF)
- Austrian Science Fund [I1224-B19] Funding Source: Medline
- Austrian Science Fund FWF [I 1224] Funding Source: Medline
- Federal Ministry of Education and Research (BMBF), Germany Funding Source: Medline
- National Centre for Research and Development (NCBiR), Poland Funding Source: Medline
- European Commission under the Seventh Framework Programme (FP7) Funding Source: Medline
- General Secretariat for Research and Technology, Ministry of Education, Life Long Learning and Religious Affairs (GSRT), Greece Funding Source: Medline
- Ministry of Higher Education, Science and Technology (MHEST), Slovenia Funding Source: Medline
- Ministry of Health (MoH), Italy Funding Source: Medline
With the development of ever more radiopharmaceuticals suitable for theranostic applications, translation of novel compounds from the preclinical stage towards clinical application becomes a bottleneck for the advances in Nuclear Medicine. This review article summarizes the current regulatory framework for clinical trials with radiopharmaceuticals in the European Union, provides a general overview of the documentation required, and addresses quality, safety, and clinical aspects to be considered. By using a recent successful example of translating a theranostic peptide radioligand, namely In-111-CP04, which targets receptors expressed in medullary thyroid carcinoma, the pathway from the preclinical development over establishing the required pharmaceutical documentation to designing and submitting a clinical trial is reviewed. Details regarding preclinical data, generation of the documentation, and final successful application are described. This article should provide an insight in an ever more complex process to bring innovations in the field of radiopharmaceuticals into patients.
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