Zobrazeno 1 - 10
of 45
pro vyhledávání: '"M Papaluca Amati"'
Publikováno v:
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz. 54:811-815
The classification procedure, introduced by the European Regulation on advanced therapy medicinal products (ATMPs), has received a tremendous interest from companies, academic and public sponsors developing ATMPs. This procedure gives companies the o
Autor:
J‐M. Husson, H. Yasurhara, M. Papaluca Amati, R. L. Williams, C. Naito, Lionel D. Edwards, S. Walker, E. Labbé
Publikováno v:
Principles and Practice of Pharmaceutical Medicine
Autor:
Tomas Salmonson, Falk Ehmann, H G Eichler, M Papaluca Amati, Christian K. Schneider, Robert Hemmings, Spiros Vamvakas, Martin Posch
Publikováno v:
Clinical pharmacology and therapeutics. 93(5)
This article analyzes the role of regulatory authorities in facilitating innovation in the pharmaceutical sector. We describe how regulators are expanding their role to be not only gatekeepers but also enablers of development. They have already respo
Publikováno v:
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz. 54(7)
The classification procedure, introduced by the European Regulation on advanced therapy medicinal products (ATMPs), has received a tremendous interest from companies, academic and public sponsors developing ATMPs. This procedure gives companies the o
Autor:
Mariam Molokhia, Bruce Carleton, Peter S. Friedmann, Emma C. Phillips, Pascal Demoly, Catherine H. Smith, M. Papaluca-Amati, L. La Grenade, Neil H. Shear, Yoon K. Loke, Munir Pirmohamed
Publikováno v:
Clinical Pharmacology & Therapeutics
Advances in genetic research and molecular biology techniques have made it possible to begin to characterize the underlying genetic factors that predispose patients to serious forms of drug-induced skin injury (DISI). To facilitate research in this a
Autor:
Giorgio Sirugo, Giuseppe Novelli, Cinzia Ciccacci, M. Papaluca Amati, N. Di Daniele, Paola Borgiani
Pharmacogenomics (PGx) and pharmacogenetics (PGt) are emerging interdisciplinary areas recently defined by the regulatory authorities at an international level as ‘the investigation of variations of DNA and RNA characteristics as related to drug re
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b3635328cb21f879507527624106025c
http://hdl.handle.net/2108/12695
http://hdl.handle.net/2108/12695
Autor:
Robert Williams, E. Labbé, C. Naito, J.M. Husson, Lionel D. Edwards, H. Yasurhara, Susan P. Walker, M. Papaluca Amati
Publikováno v:
Principles and Practice of Pharmaceutical Medicine
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0f4e851eeb6e1da31cb01c43d14b25d3
https://doi.org/10.1002/0470846291.ch29
https://doi.org/10.1002/0470846291.ch29
Publikováno v:
Pharmacologytoxicology. 86
The safety of biotechnological products used for medicinal products is addressed by EU council directives. The general principles and the regulatory framework for the handling of new drug applications within this areas are described both with respect
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