Zobrazeno 1 - 10
of 21
pro vyhledávání: '"Andrew S. Robertson"'
Autor:
Susan Berger, Robert Kowalski, Michael Garvin, Deborah Autor, Sandra Milligan, Roopal Thakkar, Carlos Garner, Mark Taisey, Mathias Hukkelhoven, Max Wegner, Peter Honig, Lina AlJuburi, Liza O’Dowd, Khyati Roberts, Helen Fitton, Jerry Stewart, Karin Van Baelen, Edward Reilly, Patrick Brady, Andrew S. Robertson
Publikováno v:
Clinical Pharmacology & Therapeutics. 109:1390-1392
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bf141f244368d14c909d0ac26449c187
https://doi.org/10.1002/cpt.2046
https://doi.org/10.1002/cpt.2046
Publikováno v:
Nature reviews. Drug discovery. 20(3)
Drug developers are increasingly applying data-driven analysis of the actions of regulatory agencies to gain insights into their expectations and applications of regulatory policy, but such strategies can be limited by the availability and quality of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::de857da2aca1df594ce6d46689112eaa
https://pubmed.ncbi.nlm.nih.gov/32483340
https://pubmed.ncbi.nlm.nih.gov/32483340
Autor:
Mark Taisey, Peter Honig, Carlos Garner, Sharon Olmstead, Andrew S. Robertson, Robert Kowalski, Karin Van Baelen, Michelle Rohrer, Khyati Roberts, Liza O’Dowd, Jerry Stewart, Michael Garvin, Max Wegner, Sandra Milligan, Edward Reilly, Roopal Thakkar, Helen Fitton, Mathias Hukkelhoven, Fabio Bisordi, Deborah Autor
Publikováno v:
Clinical pharmacology and therapeutics. 108(4)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4a40a59f0b7e552ea3978d03599e3675
https://pubmed.ncbi.nlm.nih.gov/32337707
https://pubmed.ncbi.nlm.nih.gov/32337707
Publikováno v:
PLoS Neglected Tropical Diseases, Vol 6, Iss 8, p e1750 (2012)
Externí odkaz:
https://doaj.org/article/6f9168ee0e7b443f949636f230572ff7
Publikováno v:
PLoS Neglected Tropical Diseases, Vol 6, Iss 10, p e1803 (2012)
Externí odkaz:
https://doaj.org/article/eceeb7c6155b41bf891e9364dacbff0b
Publikováno v:
Therapeutic innovationregulatory science.
Background: Since 2008, the US Food and Drug Administration (FDA) has required that drug manufacturers conduct postmarket cardiovascular outcomes trials (CVOTs) for approved type 2 diabetes mellitus (T2DM) drugs. The utility and impact of these studi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f02f778fa13e7d56364f9ce1bd722f62
https://pubmed.ncbi.nlm.nih.gov/31311308
https://pubmed.ncbi.nlm.nih.gov/31311308
Publikováno v:
Therapeutic innovationregulatory science. 54(3)
Background: “Patient experience data” (PED) refers to the systematic collection of meaningful data relating to the experiences, perspectives, needs, and priorities of patients. PED can augment traditional clinical trial data in the FDA’s review
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d5431bc1a5161d0ff9d08454ca6bb49d
https://pubmed.ncbi.nlm.nih.gov/33301134
https://pubmed.ncbi.nlm.nih.gov/33301134
Autor:
Andrew S. Robertson
Publikováno v:
American Journal of Law & Medicine. 42:524-542
In December 2014, the United States government expanded the Priority Review Voucher (“PRV” or “voucher”) program to include Ebola and other related Filoviruses. By doing so, lawmakers provided a potentially powerful incentive for drug compani
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0f94b81186e8b14e7f568455918bcfa4
https://doi.org/10.1177/0098858816658278
https://doi.org/10.1177/0098858816658278
Autor:
Max Wegner, Helen Fitton, Robert Kowalski, Peter Honig, Michelle Rohrer, Khyati Roberts, Roopal Thakkar, Mathias Hukkelhoven, Mark Taisey, Hilary Malone, Stacy Holdsworth, Andrew S. Robertson, Sandra Milligan, Carlos Garner, Liza O’Dowd, Jerry Stewart, Karin Van Baelen, Fabio Bisordi
Publikováno v:
Nature Reviews Drug Discovery. 19:365-366
Cloud-based systems for data submitted by sponsors to drug regulatory agencies have the potential to accelerate drug development, streamline regulatory review and enhance regulatory decision-making. Here, we provide a vision for integrating cloud-ena
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a6eca4e9f9078172d4ade4d94780b51c
https://doi.org/10.1038/d41573-019-00193-7
https://doi.org/10.1038/d41573-019-00193-7
Publikováno v:
Journal of Experimental Biology. 214:1981-1988
SUMMARY The trout heart is 10-fold more sensitive to Ca2+ than the mammalian heart. This difference is due, in part, to cardiac troponin C (cTnC) from trout having a greater Ca2+ affinity than human cTnC. To determine what other proteins are involved
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ca6c4ae0d6310f046e50edaa9c55350e
https://doi.org/10.1242/jeb.052860
https://doi.org/10.1242/jeb.052860