Zobrazeno 1 - 10
of 133
pro vyhledávání: '"David A, Keire"'
Autor:
Stephen Horne, Matthew D. Vera, Laxma R. Nagavelli, Vilayat A. Sayeed, Laurel Heckman, Deborah Johnson, Dan Berger, Yean Yean Yip, Carolina Lopes Krahn, Leticia Oyamada Sizukusa, Nayrton Flavio Moura Rocha, Robert N. Bream, Joachim Ludwig, David A. Keire, Gary Condran
Publikováno v:
Journal of Pharmaceutical Sciences. 112:1166-1182
N-Nitrosamines (also referred to as nitrosamines) are a class of substances, many of which are highly potent mutagenic agents which have been classified as probable human carcinogens. Nitrosamine impurities have been a concern within the pharmaceutic
Publikováno v:
Data in Brief, Vol 21, Iss , Pp 644-652 (2018)
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
Externí odkaz:
https://doaj.org/article/2aee753771c24108be32e10b7d5caf87
Publikováno v:
Frontiers in Medicine, Vol 7 (2020)
Externí odkaz:
https://doaj.org/article/85adde71a0984296b09654345898ee0b
Autor:
Deyun Wang, You Zhuo, Mike Karfunkle, Sharadrao M. Patil, Cameron J. Smith, David A. Keire, Kang Chen
Publikováno v:
Molecules, Vol 26, Iss 14, p 4251 (2021)
Peptide and protein drug molecules fold into higher order structures (HOS) in formulation and these folded structures are often critical for drug efficacy and safety. Generic or biosimilar drug products (DPs) need to show similar HOS to the reference
Externí odkaz:
https://doaj.org/article/0e8386945d20489ea9b1a4234113e6b6
Autor:
Xilin Li, Xiaobo He, Yuan Le, Xiaoqing Guo, Matthew S. Bryant, Aisar H. Atrakchi, Timothy J. McGovern, Karen L. Davis-Bruno, David A. Keire, Robert H. Heflich, Nan Mei
Publikováno v:
Archives of Toxicology. 96:3077-3089
Publikováno v:
Molecular Pharmaceutics. 19:2142-2150
Autor:
Lucio Mauri, Maria Marinozzi, Nisarga Phatak, Michael Karfunkle, Kalib St. Ange, Marco Guerrini, David A. Keire, Robert J. Linhardt
Publikováno v:
Frontiers in Medicine, Vol 6 (2019)
The US Food and Drug Administration has encouraged the reintroduction of bovine heparin drug product to the US market to mitigate the risks of heparin shortages and potential adulteration or contamination of the primary source which is porcine hepari
Externí odkaz:
https://doaj.org/article/85bd7bce74fe41f19cc3d84b117dd050
Publikováno v:
Pharmaceutical Research.
Autor:
Xilin Li, Yuan Le, Ji-Eun Seo, Xiaoqing Guo, Yuxi Li, Si Chen, Roberta A. Mittelstaedt, Nyosha Moore, Sharon Guerrero, Audrey Sims, Sruthi T. King, Aisar H. Atrakchi, Timothy J. McGovern, Karen L. Davis-Bruno, David A. Keire, Rosalie K. Elespuru, Robert H. Heflich, Nan Mei
Publikováno v:
Regulatory Toxicology and Pharmacology. 141:105410
Autor:
David A. Keire, Robert Bream, Uwe Wollein, null Schmaler-Ripcke, Annette Burchardt, Massimiliano Conti, Adam Zmysłowski, Peter Keizers, Justin Morin, Jalene Poh, Mark George, Michael Wierer
Publikováno v:
The AAPS Journal. 24