Zobrazeno 1 - 3
of 3
pro vyhledávání: '"Katherine Arch-Douglas"'
Autor:
Khurram Sunasara, Katherine Arch-Douglas, Lavinia M. Lewis, Roberto Rodriguez, Michele Bailey Piatchek, Parag Kolhe
Publikováno v:
PDA journal of pharmaceutical science and technology. 74(2)
Trumenba (MenB-FHbp; bivalent rLP2086), the first meningococcal serogroup B vaccine approved in the United States and subsequently approved in Europe, Canada, and Australia, is well-characterized. Pfizer devised a control strategy approach by using a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f04806611132be19f94e561f10fb8a19
https://pubmed.ncbi.nlm.nih.gov/31519784
https://pubmed.ncbi.nlm.nih.gov/31519784
Autor:
Sriram Srinivasan, Brad Evans, John Farley, Eric Bortell, Weiqiang Sun, Khurram Sunasara, Daniel Griffin, Michele Bailey Piatchek, Scott Cook, Katherine Arch-Douglas, John Cundy
Publikováno v:
Vaccine. 36(22)
The phrase "Process is the Product" is often applied to biologics, including multicomponent vaccines composed of complex components that evade complete characterization. Vaccine production processes must be defined and locked early in the development
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::feae658bf780428c8c279d6fec6b6543
https://pubmed.ncbi.nlm.nih.gov/28433330
https://pubmed.ncbi.nlm.nih.gov/28433330
Autor:
Katherine Arch-Douglas, Bruce Thompson, Heather L. Davis, Jennifer Marie Thorn, Dana M. Evans, Michael J. McCluskie, Justin B. Sperry
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 44(3)
The United States Food and Drug Administration recently removed the requirement for a General Safety Test (GST) for biologics in the Code of Federal Regulations (21 CFR 610.11). The GST, as well as abnormal toxicity (European Pharmacopeia) and innocu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5505ef99dbaa98fa39b04ce209500f99
https://pubmed.ncbi.nlm.nih.gov/26996102
https://pubmed.ncbi.nlm.nih.gov/26996102