Lessons Learned from the Clinical Development and Market Authorization of Glybera

Bryant and colleagues follow the development of Glybera (alipogene tiparvovec), the first gene therapy product approved in the European Union, from early preclinical studies through the approval process. They review key data from human and animal studies with an emphasis on issues that will be criti...

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Detalhes bibliográficos
Main Authors: Bryant, Laura M., Christopher, Devin M., Giles, April R., Hinderer, Christian, Rodriguez, Jesse L., Smith, Jenessa B., Traxler, Elizabeth A., Tycko, Josh, Wojno, Adam P., Wilson, James M.
Formato: Artigo
Idioma:Inglês
Publicado em: Mary Ann Liebert, Inc. 2013
Assuntos:
Review
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3992977/
https://ncbi.nlm.nih.gov/pubmed/23808604
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1089/humc.2013.087
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