Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology
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) th...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2024-01-01
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| Series: | Pharmacological Research |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1043661823004012 |
| _version_ | 1797372107190960128 |
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| author | Antonio Gómez-Outes Aránzazu Sancho-López Antonio J. Carcas Sansuan Cristina Avendaño-Solá |
| author_facet | Antonio Gómez-Outes Aránzazu Sancho-López Antonio J. Carcas Sansuan Cristina Avendaño-Solá |
| author_sort | Antonio Gómez-Outes |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T18:31:05Z |
| format | Article |
| id | doaj.art-d0eb1a89545e4821b467ff6ca22fdfbd |
| institution | Directory Open Access Journal |
| issn | 1096-1186 |
| language | English |
| last_indexed | 2024-03-08T18:31:05Z |
| publishDate | 2024-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Pharmacological Research |
| spelling | doaj.art-d0eb1a89545e4821b467ff6ca22fdfbd2023-12-30T04:41:08ZengElsevierPharmacological Research1096-11862024-01-01199107045Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacologyAntonio Gómez-Outes0Aránzazu Sancho-López1Antonio J. Carcas Sansuan2Cristina Avendaño-Solá3Division of Pharmacology and Clinical Drug Evaluation, Medicines for Human Use, Spanish Agency for Medicines and Healthcare Products (AEMPS), Madrid, SpainClinical Pharmacology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain; Corresponding author.Clinical Pharmacology Department, Hospital Universitario La Paz, Madrid, SpainClinical Pharmacology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, SpainSince 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.http://www.sciencedirect.com/science/article/pii/S1043661823004012Academic clinical trialsAccess to non-approved medicinesAdvanced therapiesHospital exemption |
| spellingShingle | Antonio Gómez-Outes Aránzazu Sancho-López Antonio J. Carcas Sansuan Cristina Avendaño-Solá Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology Pharmacological Research Academic clinical trials Access to non-approved medicines Advanced therapies Hospital exemption |
| title | Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology |
| title_full | Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology |
| title_fullStr | Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology |
| title_full_unstemmed | Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology |
| title_short | Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology |
| title_sort | clinical research and drug regulation in the challenging times of individualized therapies a pivotal role of clinical pharmacology |
| topic | Academic clinical trials Access to non-approved medicines Advanced therapies Hospital exemption |
| url | http://www.sciencedirect.com/science/article/pii/S1043661823004012 |
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