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 111In-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.

Kolenc Peitl, P., Rangger, C., Garnuszek, P., Mikolajczak, R., Hubalewska-Dydejczyk, A., Maina, T., et al. (2019). Clinical translation of theranostic radiopharmaceuticals: Current regulatory status and recent examples. JOURNAL OF LABELLED COMPOUNDS & RADIOPHARMACEUTICALS, 62(10), 673-683 [10.1002/jlcr.3712].

Clinical translation of theranostic radiopharmaceuticals: Current regulatory status and recent examples

Erba P.
Penultimo
;
2019

Abstract

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 111In-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.
Articolo in rivista - Articolo scientifico
111; In-CP04; clinical trial; peptide radiopharmaceuticals; regulatory framework; theranostics nuclear medicine;
English
2019
62
10
673
683
open
Kolenc Peitl, P., Rangger, C., Garnuszek, P., Mikolajczak, R., Hubalewska-Dydejczyk, A., Maina, T., et al. (2019). Clinical translation of theranostic radiopharmaceuticals: Current regulatory status and recent examples. JOURNAL OF LABELLED COMPOUNDS & RADIOPHARMACEUTICALS, 62(10), 673-683 [10.1002/jlcr.3712].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/419744
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