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Clinical translation of theranostic radiopharmaceuticals: Current regulatory status and recent examples
Author(s) -
Kolenc Peitl Petra,
Rangger Christine,
Garnuszek Piotr,
Mikolajczak Renata,
HubalewskaDydejczyk Alicja,
Maina Theodosia,
Erba Paola,
Decristoforo Clemens
Publication year - 2019
Publication title -
journal of labelled compounds and radiopharmaceuticals
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.432
H-Index - 47
eISSN - 1099-1344
pISSN - 0362-4803
DOI - 10.1002/jlcr.3712
Subject(s) - documentation , clinical trial , medical physics , process management , medicine , risk analysis (engineering) , computer science , business , pathology , programming language
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 111 In‐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.