Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology

Autor: Antonio Gómez-Outes, Aránzazu Sancho-López, Antonio J. Carcas Sansuan, Cristina Avendaño-Solá
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Pharmacological Research, Vol 199, Iss , Pp 107045- (2024)
Druh dokumentu: article
ISSN: 1096-1186
DOI: 10.1016/j.phrs.2023.107045
Popis: Since the 1980s, medical specialists in Clinical Pharmacology have been playing a crucial role in the development of drug regulation in Spain. In this article we report on the activities carried out and the prospects for development in three very relevant areas from the regulatory perspective: 1) the development of stable public infrastructures to facilitate non-commercial clinical research with medicines, 2) the regulatory aspects of individual access to medicines in special situations, beyond their regular access after marketing approval and funding by the National Health System, and 3) the challenges of development and access to advanced therapies, with special reference to the figure of the hospital exemption.
Databáze: Directory of Open Access Journals