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Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis
The market authorization procedure for medicinal products for human use is relying on their demonstrated efficacy, safety, and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (AT...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Frontiers Research Foundation
2012
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278850/ https://www.ncbi.nlm.nih.gov/pubmed/22347860 http://dx.doi.org/10.3389/fphar.2012.00012 |