Zobrazeno 1 - 7
of 7
pro vyhledávání: '"David Semin"'
Autor:
Alejandra, Gallegos, Jian, Liu, Michael, Ronk, Li, Qi, Kim, Li, David, Semin, Yasser, Nashed-Samuel
Publikováno v:
Journal of Pharmaceutical Sciences. 111:1599-1604
As a popular format of primary container closure systems, rubber stoppered glass vials are often used in storing and delivering lyophilized and liquid formulated therapeutic protein products. Assessing extractables and leachables from rubber stoppere
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2cfbd93e0294f75d8c78fa2f2ca0bb80
https://doi.org/10.1016/j.xphs.2022.03.001
https://doi.org/10.1016/j.xphs.2022.03.001
Autor:
Jinbo Hu, Ali Kyad, Kathleen Burke, Lisa Sakiyama, Carolina Moraes De Souza, Shawn Pope, Laura Blue, Dawn Cohen, David Semin, Chetan Goudar
Publikováno v:
Journal of Pharmaceutical Sciences.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4b4b2b6ec4b323f4ca86af1106167c35
https://doi.org/10.1016/j.xphs.2023.02.023
https://doi.org/10.1016/j.xphs.2023.02.023
Publikováno v:
PDA journal of pharmaceutical science and technology.
In the biopharmaceutical industry, the observation of a single particle in a vial or syringe may result in entire lots of drug product recalls. USP chapters787and788describe light obscuration methods and particle collection (membrane filtration) foll
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ca5a3abf002d40183721863b6683ac2b
https://pubmed.ncbi.nlm.nih.gov/36572486
https://pubmed.ncbi.nlm.nih.gov/36572486
Autor:
Stephanie, Moore, Peter, Masatani, Yasser, Nashed-Samuel, Gianni, Torraca, Michael, Akers, Jeremy, Gastwirt, Chakradhar, Padala, David, Semin
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. :pdajpst.2021.012686
A previously unreported particle type was observed during routine visual vial inspection of a liquid drug product and suspected to be the result of vial delamination. Delamination is the corrosive attack on the interior surface of a glass container r
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bc1aea0a83a5b0927a2da6646f1701b9
https://doi.org/10.5731/pdajpst.2021.012686
https://doi.org/10.5731/pdajpst.2021.012686
Publikováno v:
Journal of Chromatographic Science; Aug2008, Vol. 46 Issue 7, p637-642, 6p
Autor:
Helming Tan, Maggie Reed, Kyung H. Gahm, Tony King, Mina Dilmeghani Seran, Tracy Bostick, Van Luu, David Semin, Janet Cheetham, Rob Larsen, Mike Martinelli, Paul Reider
Publikováno v:
Organic Process Research & Development; Dec2007, Vol. 12 Issue 1, p58-65, 8p
Publikováno v:
Journal of Separation Science; May2005, Vol. 28 Issue 7, p619-626, 8p