Zobrazeno 1 - 4
of 4
pro vyhledávání: '"Paula Gish"'
Autor:
Kory Kreimeyer, Oanh Dang, Jonathan Spiker, Paula Gish, Jessica Weintraub, Eileen Wu, Robert Ball, Taxiarchis Botsis
Publikováno v:
Frontiers in Drug Safety and Regulation, Vol 2 (2022)
The US Food and Drug Administration (FDA) receives millions of postmarket adverse event reports for drug and therapeutic biologic products every year. One of the most salient issues with these submissions is report duplication, where an adverse event
Externí odkaz:
https://doaj.org/article/7eec6d5ca3354cf68344523790afa879
Autor:
Suranjan De, Robert Ball, Paula Gish, Debra Boxwell, Vicky Chan, Taxiarchis Botsis, Kory Kreimeyer, Oanh Dang, Eileen Wu, Connie Cheng, Jarushka Naidoo, Gary L. Rosner, Allison Lardieri, Harold P Lehmann, Jonathan Spiker
Publikováno v:
Drug Safety. 43:905-915
The US FDA receives more than 2 million postmarket reports each year. Safety Evaluators (SEs) review these reports, as well as external information, to identify potential safety signals. With the increasing number of reports and the size of external
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f8116cd828fa5cc216cb17dcda0909f8
https://doi.org/10.1007/s40264-020-00945-0
https://doi.org/10.1007/s40264-020-00945-0
Autor:
Islam Younis, Kyong Hyon, Paula Gish, William Tauber, Esther H. Zhou, Poonam Mishra, Kelly Y. Cao, Ping Zhao, Mario R. Sampson
Publikováno v:
The Journal of Clinical Pharmacology. 59:500-509
Although current quetiapine labeling recommends that its dosage should be lowered 6-fold when coadministered with strong cytochrome P450 (CYP)3A inhibitors, a reported case of coma in a patient receiving quetiapine with lopinavir and ritonavir prompt
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9c6cc6021ecbe83830107206e65502ff
https://doi.org/10.1002/jcph.1345
https://doi.org/10.1002/jcph.1345
Publikováno v:
The Journal of pediatrics. 155(3)
We reviewed Food and Drug Administration postmarketing reports of central nervous system (CNS) anticholinergic effects in association with oxybutynin. Taking domestic usage by age group into account, there is a disproportionately higher number of CNS
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::edc7806d0a36f100615b223ea9788e67
https://pubmed.ncbi.nlm.nih.gov/19732583
https://pubmed.ncbi.nlm.nih.gov/19732583