Zobrazeno 1 - 10
of 12
pro vyhledávání: '"Nina L. Hunter"'
Autor:
Nina L. Hunter, Rachel E. Sherman, Michael J. Rappel, Kyle O. Hair, Robert M. Califf, April I. Alexandrow
Publikováno v:
Clinical and Translational Science. 10:124-127
Therapeutics known as combination products because they combine drug, device, and/or biologic elements can offer important advantages relative to single‐modality products. However, regulatory policy in this arena has lagged relative to increases in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::07f541884218f9a2cdf5c2006a01e69c
https://doi.org/10.1111/cts.12441
https://doi.org/10.1111/cts.12441
Publikováno v:
Nature reviews. Drug discovery. 16(11)
Scientific advances, in combination with government incentives and commercial opportunity, have fuelled strong investment in orphan drugs, resulting in many innovative therapies. Here, we discuss the approach of the FDA to a range of issues that rema
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::503159affdfae1efff702ab43b09c70b
https://pubmed.ncbi.nlm.nih.gov/28860647
https://pubmed.ncbi.nlm.nih.gov/28860647
Publikováno v:
Nature reviews. Drug discovery. 16(5)
Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about the optimal use of medical products in real-world practice. Here, we argue that contrary to widespread impressions, existing FDA re
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::30eaf0c5e5fe8a324497085593aef971
https://pubmed.ncbi.nlm.nih.gov/28232726
https://pubmed.ncbi.nlm.nih.gov/28232726
Autor:
Danica Marinac-Dabic, Thomas G. Gross, Lisa M. LaVange, Gerry W. Gray, Lilly Q. Yue, Robert Temple, Jeffrey Shuren, Janet Woodcock, Steven A. Anderson, Melissa A. Robb, Nina L. Hunter, Robert M. Califf, Peter W. Marks, Gerald J. Dal Pan, Rachel E. Sherman
Publikováno v:
The New England journal of medicine. 375(23)
The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiv
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::76a0bd336ebd21613a33ee7b5bb15d44
https://pubmed.ncbi.nlm.nih.gov/29733448
https://pubmed.ncbi.nlm.nih.gov/29733448
Autor:
Rachel E. Sherman, Nina L. Hunter
Publikováno v:
Nature Reviews Drug Discovery. 16:513-514
New opportunities to develop innovative — and often complex — products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing effo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::500e0baf3ccb6da6ab2b77f3a78742d4
https://doi.org/10.1038/nrd.2017.66
https://doi.org/10.1038/nrd.2017.66
Publikováno v:
JAMA. 314(23)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::82ecd29c6c036a9bb7f051b3d6778fd7
https://pubmed.ncbi.nlm.nih.gov/26584067
https://pubmed.ncbi.nlm.nih.gov/26584067
Publikováno v:
Developmental Dynamics. 235:279-284
Frodo has been identified as a protein interacting with Dishevelled, an essential mediator of the Wnt signaling pathway, critical for the determination of cell fate and polarity in embryonic development. In this study, we use specific gene probes to
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3188b7078228af13453dbc37d64f267d
https://doi.org/10.1002/dvdy.20609
https://doi.org/10.1002/dvdy.20609
Autor:
Nina L. Hunter, Susan M. Dymecki
Publikováno v:
Development (Cambridge, England). 134(19)
Both hindbrain roof plate epithelium (hRPe) and hindbrain choroid plexus epithelium (hCPe) produce morphogens and growth factors essential for proper hindbrain development. Despite their importance, little is known about how these essential structure
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3715a7dfe5ea40132afa83648be2061e
https://pubmed.ncbi.nlm.nih.gov/17728348
https://pubmed.ncbi.nlm.nih.gov/17728348
Autor:
Amna Ibrahim, Nina L. Hunter, Robert Justice, Julia A. Beaver, Todd R. Palmby, Patricia Cortazar, Richard Pazdur, Gideon M. Blumenthal
Publikováno v:
Journal of Clinical Oncology. 32:e22181-e22181
e22181 Background: The development of targeted therapies for cancer has thrived with improved understanding of genetic mechanisms and co-development of companion diagnostics. Methods: Clinical tria...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0fed57159d70c4fc00ad8c097b5e0f10
https://doi.org/10.1200/jco.2014.32.15_suppl.e22181
https://doi.org/10.1200/jco.2014.32.15_suppl.e22181
Publikováno v:
Genesis: The Journal of Genetics & Development; Mar2005, Vol. 41 Issue 3, p99-109, 11p