Zobrazeno 1 - 10
of 17
pro vyhledávání: '"Lesha D. Shah"'
Publikováno v:
Medicine Access @ Point of Care, Vol 5 (2021)
Introduction: Physicians in the United States play an essential role guiding patients through single patient pre-approval access (PAA) to investigational medical products via either the Food and Drug Administration (FDA)’s Expanded Access (EA) or t
Externí odkaz:
https://doaj.org/article/51cc7330963b40d482a62c0373c527c2
Publikováno v:
Pharmaceutical Medicine. 37:17-24
Currently, pediatric research involving investigational gene therapies (GT, used without intending to imply a therapeutic effect) targets a broad range of indications (including rare and ultra-rare diseases) that vary in severity and availability of
Autor:
Steven Joffe, Albert J. Allen, Jonathan M. Davis, Elisa Koppelman, Susan Z. Kornetsky, Grace Marie V. Ku, Victoria A. Miller, Jennifer Preston, Lesha D. Shah, Barbara E. Bierer
Publikováno v:
Pediatric Research.
Publikováno v:
The American Journal of Bioethics. 21:28-31
In their paper, “Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?” Holly Fernandez Lynch and colleagues have present...
Autor:
Lesha D. Shah, John Lantos, Cara Hunt, Andrew McFadyen, Rafael Escandon, Alison Bateman-House
Publikováno v:
The American Journal of Bioethics. 22:1-3
Autor:
Lisa R. Fortuna, Lesha D. Shah
Publikováno v:
Journal of the American Academy of Child and Adolescent Psychiatry.
Racialized trauma can come directly from other people or can be experienced within a wider system. It can come as the result of a direct experience when racism is enacted on you, vicariously-such as when you see videos of other people facing racism-a
Publikováno v:
Webb, J, Shah, L D & Bateman-house, A 2021, ' Siblings and Discordant Eligibility for Gene Therapy Research: Considering Parental Requests for Non-Trial "Compassionate Use” ', Clinical Ethics, pp. 147775092098357 . https://doi.org/10.1177/1477750920983571
Deciding whether to grant an expanded access request for a child whose sibling is enrolled in a gene therapy trial involves a number of complex factors: considering the best interests of the child, the psychosocial and economic impact on the family,
Publikováno v:
The American Journal of Bioethics. 20:4-17
Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research. ...
Autor:
Lesha D. Shah, Kelly McBride Folkers, Carolyn Riley Chapman, Andrew McFadyen, Alison Bateman-House
Publikováno v:
The American Journal of Bioethics. 19:22-25
Preapproval nontrial access, historically called “compassionate use,” and certain off-label usage of approved medical products are two forms of innovative practice, defined by Earl as a situation “...
Autor:
Laura L. Kimberly, Kelly McBride Folkers, Phoebe Friesen, Darren Sultan, Gwendolyn P. Quinn, Alison Bateman-House, Brendan Parent, Craig Konnoth, Aron Janssen, Lesha D. Shah, Rachel Bluebond-Langner, Caroline Salas-Humara
Transgender and gender-nonconforming (TGNC) youth who suffer from gender dysphoria are at a substantially elevated risk of numerous adverse physical and psychosocial outcomes compared with their cisgender peers. Innovative treatment options used to s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::aba7e4410510b59c8e8efbf19e4a2db0
https://doi.org/10.1542/9781610025423-ethical
https://doi.org/10.1542/9781610025423-ethical