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[Clinical trials with advanced therapy medicinal products].
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 2010For advanced therapies, the same basic principles for assessment apply as for any other biotechnological medicinal product. Nevertheless, the extent of data for quality, safety, and efficacy can be highly specific. Until recently, advanced therapies were not uniformly regulated across Europe, e.g., tissue engineered products were regulated either as ...
M, Schüssler-Lenz, C K, Schneider
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Advanced therapy medicinal products: Gene therapy
Pharmaceuticals Policy and Law, 2015Ayala, Antonio +4 more
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Comparability: What We Can Learn from the Review of Advanced Therapy Medicinal Products
Regenerative Medicine, 2021Alison Wilson, Alexis Cockroft
exaly
The advanced therapies medicinal products - A Belgian perspective
2008Cf ...
Martens, Marc, Carbonelle, Nicolas
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[European pharmacovigilance of advanced therapy medicinal products].
Annales pharmaceutiques francaisesAdvanced therapy medicinal products (ATMPs) are playing an increasingly important role in therapeutics, and sometimes represent the only hope of improving or even curing some pathologies. Because of their biological origin, composition, mode of action, and their frequent technical complexity, ATMPs are potentially generating new risks.
Nadine, Petitpain +6 more
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Europe’s Advanced Therapy Medicinal Products: chances and challenges
Expert Review of Medical Devices, 2009Heike, Mertsching, Thorsten, Walles
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