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Pàgina inicial > Articles > Articles publicats > Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product : |
Data: | 2021 |
Resum: | A systematic and ordered product development program, in compliance with current quality and regulatory standards, increases the likelihood of yielding a successful advanced therapy medicinal product (ATMP) for clinical use as safe and effective therapy. As this is a novel field, little accurate information is available regarding the steps to be followed, and the information to be produced to support the development and use of an ATMP. Notably, successful clinical translation can be somewhat cumbersome for academic researchers. In this article, we have provided a summary of the available information, supported by our experience in Spain throughout the development of an ATMP for myocardial infarction, from the pre-clinical stage to phase I clinical trial approval. |
Ajuts: | Instituto de Salud Carlos III RD16/0011/0006 Instituto de Salud Carlos III RD16/0011/0028 Instituto de Salud Carlos III CB16/11/00403 Instituto de Salud Carlos III PI18/00256 Instituto de Salud Carlos III PIC18/00014 Instituto de Salud Carlos III ICI19/00039 Instituto de Salud Carlos III PI19/01788 Agència de Gestió d'Ajuts Universitaris i de Recerca 2017-SGR-483 Agència de Gestió d'Ajuts Universitaris i de Recerca 2017-SGR-719 Agencia Estatal de Investigación SAF2017-84324-C2-1-R |
Nota: | Altres ajuts: PERIS Program (Health Department) [SLT002/16/00234 and SLT002/16/00209] and CERCA Program; La Caixa Banking Foundation. This work has also been funded by the Sociedad Española de Cardiología and by the Call for Expression of Interest (EoI) for Collaborative Projects on Regenerative Medicine 2019 of Center for Regenerative Medicine of Barcelona (CMR[B]). |
Drets: | Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. |
Llengua: | Anglès |
Document: | Article de revisió ; recerca ; Versió publicada |
Matèria: | Advanced therapy medicinal product ; Investigational medicinal product ; Investigational medicinal product dossier (IMPD) ; Translational (regulation) ; Regulatory agency |
Publicat a: | Frontiers in Cardiovascular Medicine, Vol. 8 (february 2021) , ISSN 2297-055X |
10 p, 1.8 MB |