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EMEA and Gene Therapy Medicinal Products Development in the European Union

The evaluation of quality, safety, and efficacy of medicinal products by the European Medicines Evaluation Agency (EMEA) via the centralized procedure is the only available regulatory procedure for obtaining marketing authorization for gene therapy (GT) medicinal products in the European Union. The...

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Detalhes bibliográficos
Main Authors: Papaluca Amati, Marisa, Pignatti, Francesco, Nolte, Alexis, Amerasinghe, Nirosha, Gustafsson, Daniel, Moulon, Isabelle, Le Courtois, Patrick
Formato: Artigo
Idioma:Inglês
Publicado em: Hindawi Publishing Corporation 2003
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC179762/
https://ncbi.nlm.nih.gov/pubmed/12686717
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1155/S1110724303209104
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