APA
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Bryant*, L., Christopher*, D. M., Giles*, A. R., Hinderer*, C. J., Rodriguez*, J., Smith*, J., … Wilson, J. M. (2013). Lessons learned from the clinical development and market authorization of Glybera. Human Gene Therapy Clinical Development.
Chicago/Turabian
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Bryant*, L., Devin M. Christopher*, April R. Giles*, Christian J. Hinderer*, Jesse Rodriguez*, J. Smith*, Elizabeth A. Traxler*, Josh Tycko*, Adam P. Wojno*, and James M. Wilson. “Lessons Learned from the Clinical Development and Market Authorization of Glybera.” Human Gene Therapy Clinical Development (2013).
MLA
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Bryant*, L., et al. “Lessons Learned from the Clinical Development and Market Authorization of Glybera.” Human Gene Therapy Clinical Development, 2013.
BibTeX Click to copy
@article{l2013a,
title = {Lessons learned from the clinical development and market authorization of Glybera.},
year = {2013},
journal = {Human Gene Therapy Clinical Development},
author = {Bryant*, L. and Christopher*, Devin M. and Giles*, April R. and Hinderer*, Christian J. and Rodriguez*, Jesse and Smith*, J. and Traxler*, Elizabeth A. and Tycko*, Josh and Wojno*, Adam P. and Wilson, James M.}
}
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 critical to other gene therapy products. The article concludes with an analysis of the complex review process that eventually led to Glybera's approval.