Zobrazeno 1 - 10
of 31
pro vyhledávání: '"Cynthia D. Sommers"'
Autor:
Wei Ye, David A. Keire, Cynthia D. Sommers, Jason D. Rodriguez, Tim Andres Marzan, Jingyue Yang
Publikováno v:
The AAPS Journal
A private testing laboratory reported in a Citizen Petition (CP) to FDA that 16 of 38 metformin drug products they tested had N-nitrosodimethyl amine (NDMA) amounts above the allowable intake (AI) of 96 ng/day. Because the FDA had been monitoring dru
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 160:238-243
Protamine sulfate (PS) is an FDA approved drug used to reverse heparin-induced anticoagulation in patients. Protamine sulfate is a mixture of primarily four ∼4 kDa arginine-rich cationic polypeptide chains derived from chum (Oncorhynchus keta) salm
Autor:
David G. Strauss, Jeffry Florian, Zongming Gao, David A. Keire, Timothy Lex, Xiaomei Han, Jingyue Yang, Tim Andres Marzan, Jason D. Rodriguez, Wei Ye, Cynthia D. Sommers, Michael Karfunkle
Publikováno v:
JAMA Network Open. 4:e2118253
Importance A publication reported thatN-nitrosodimethylamine (NDMA), a probable human carcinogen, was formed when ranitidine and nitrite were added to simulated gastric fluid. However, the nitrite concentrations used were greater than the range detec
Publikováno v:
Data in Brief, Vol 21, Iss, Pp 644-652 (2018)
Data in Brief
Data in Brief
Protamine sulfate (PS) is an approximately 4 kDa cationic polypeptide derived from chum salmon used to reverse heparin-induced anticoagulation in patients. Because the presence of residual host cell salmon DNA (resDNA) in PS drug product can pose saf
Autor:
Joann Ravi, Alexandra M. Johnson, Grace M. Lee, Edimara S. Reis, Cynthia D. Sommers, Sanjay Khandelwal, Jian Liu, John D. Lambris, David A. Keire, Gowthami M. Arepally
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8a7b1ec8028dcbd6985259324edbd4b7
https://europepmc.org/articles/PMC6288012/
https://europepmc.org/articles/PMC6288012/
Autor:
Swamy K. Polumuri, David A. Keire, Roshni Rao, Gowthami M. Arepally, Cynthia D. Sommers, Lydia A. Haile, Daniela Verthelyi
Publikováno v:
Thrombosis research. 159
Introduction Heparin-induced thrombocytopenia (HIT) is an immune-mediated complication of heparin anticoagulation therapy resulting in thrombocytopenia frequently accompanied by thrombosis. Current evidence suggests that HIT is associated with antibo
Autor:
Timothy K. Toby, Ali Al-Hakim, Hongping Ye, Houman Ghasriani, David A. Keire, Richard E. Kolinski, Cynthia D. Sommers, Wei Ye, Michael L. Trehy, Lucinda F. Buhse
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 85:99-107
During the 2007-2008 heparin crisis it was found that the United States Pharmacopeia (USP) testing monograph for heparin sodium or low molecular weight heparins did not detect the presence of the contaminant, oversulfated chondroitin sulfate (OSCS).
Autor:
Houman Ghasriani, Michael T. Boyne, Vincent L. Vilker, Cynthia D. Sommers, Eric Pang, David A. Keire, Robert T. Berendt
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 85:108-117
Tacrolimus (FK506) is a potent, narrow therapeutic index, immunosuppressive drug used to avoid organ rejection in patients that have undergone organ transplantation. Recent clinical reports suggested a significant reduction in the tacrolimus concentr
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. :28-35
The polyanion oversulfated chondroitin sulfate (OSCS) was identified as a contaminant in heparin products and was associated with severe hypotensive responses and other symptoms in patients receiving the drug. The OSCS associated adverse reactions we
Publikováno v:
Antimicrobial Agents and Chemotherapy. 56:2824-2830
In response to a published concern about the potency and quality of generic vancomycin products, the United States Food and Drug Administration investigated a small sampling of the vancomycin products available in North America with regard to purity,