Zobrazeno 1 - 10
of 38
pro vyhledávání: '"Adam C, Fisher"'
Autor:
Thomas F. O'Connor, Sharmista Chatterjee, Johnny Lam, Dolores Hernán Pérez de la Ossa, Leticia Martinez-Peyrat, Marcel H.N. Hoefnagel, Adam C. Fisher
Publikováno v:
International Journal of Pharmaceutics: X, Vol 8, Iss , Pp 100274- (2024)
Process models are a growing tool for pharmaceutical manufacturing process design and control. The Industry 4.0 paradigm promises to increase the amount of data available to understand manufacturing processes. Tools such as Artificial Intelligence (A
Externí odkaz:
https://doaj.org/article/6619b4794e8243f7b9e0806374264fea
Autor:
Russie Tran, Grace Fraser, Adam C. Fisher, Sau L. Lee, Ashley Boam, Stelios Tsinontides, Jennifer Maguire, Lawrence X. Yu, Susan Rosencrance, Steven Kozlowski, Don Henry
Publikováno v:
International Journal of Pharmaceutics: X, Vol 7, Iss , Pp 100239- (2024)
A network of regulatory innovations brings a holistic approach to improving the submission, assessment, and lifecycle management of pharmaceutical quality information in the U.S. This dedicated effort in the FDA’s Center for Drug Evaluation and Res
Externí odkaz:
https://doaj.org/article/c9291cab2cd44d1896219ae4e3471c7d
Publikováno v:
The AAPS Journal. 25
Approval of the first generic 0.05% cyclosporine ophthalmic emulsion (COE) in the U.S. represents a milestone achievement of the science and research program in the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER).
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ab3e40e9dadefb3950c2e58d34b0acd2
https://doi.org/10.1208/s12248-023-00781-x
https://doi.org/10.1208/s12248-023-00781-x
Autor:
Adam C. Fisher, William Liu, Andreas Schick, Mahesh Ramanadham, Sharmista Chatterjee, Raphael Brykman, Sau L. Lee, Steven Kozlowski, Ashley B. Boam, Stelios C. Tsinontides, Michael Kopcha
Publikováno v:
International journal of pharmaceutics. 622
Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ef8e9b6d2f213c2ed68e10f8ed3c0fe0
https://pubmed.ncbi.nlm.nih.gov/35500688
https://pubmed.ncbi.nlm.nih.gov/35500688
Autor:
Erin, Leigh Wood, Akshaya, Tatke, Alex, Viehmann, Melika, Ashtiani, Richard L, Friedman, Michael, Kopcha, Adam C, Fisher
Publikováno v:
International Journal of Pharmaceutics. 625:122119
An international sampling study yielded 69 samples of extended-release prescription pharmaceuticals for legal sale in the U.S. Samples included 29 lots of innovator and 40 lots of generic solid oral extended-release drugs manufactured at 16 different
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b8a7ac6ab1d78c57d60b8679389b3be4
https://doi.org/10.1016/j.ijpharm.2022.122119
https://doi.org/10.1016/j.ijpharm.2022.122119
Publikováno v:
Trends in Biotechnology. 37:253-267
There is a trend across the pharmaceutical sector toward process intensification and continuous manufacturing to produce small-molecule drugs or biotechnology products. For biotechnology products, advancing the manufacturing technology behind upstrea
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::921e5ec8abd1c9e1566cea557f7470a1
https://doi.org/10.1016/j.tibtech.2018.08.008
https://doi.org/10.1016/j.tibtech.2018.08.008
Autor:
Christian Feiler, Adam C Fisher, Jason T Boock, Matthew J Marrichi, Lori Wright, Philipp A M Schmidpeter, Wulf Blankenfeldt, Martin Pavelka, Matthew P DeLisa
Publikováno v:
PLoS ONE, Vol 8, Iss 9, p e73123 (2013)
Directed evolution can be a powerful tool for revealing the mutational pathways that lead to more resistant bacterial strains. In this study, we focused on the bacterium Mycobacterium tuberculosis, which is resistant to members of the β-lactam class
Externí odkaz:
https://doaj.org/article/1c03d57a53194acba870655dde9b2e96
Publikováno v:
AAPS PharmSciTech. 21(7)
To develop a comprehensive understanding of pharmaceutical drug substance manufacturing (DSM) processes, we conducted a data mining study to examine 50 new drug applications (NDAs) approved in 2010–2016. We analyzed the prevalence of several freque
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bd4cf5d4b2921682311f4c3a9c006c42
https://pubmed.ncbi.nlm.nih.gov/33033946
https://pubmed.ncbi.nlm.nih.gov/33033946
Autor:
Adam C Fisher, Matthew P DeLisa
Publikováno v:
PLoS ONE, Vol 3, Iss 6, p e2351 (2008)
Green fluorescent protein (GFP) has undergone a long history of optimization to become one of the most popular proteins in all of cell biology. It is thermally and chemically robust and produces a pronounced fluorescent phenotype when expressed in ce
Externí odkaz:
https://doaj.org/article/4905e21c4cee4fcda24399bac1d694cc
Autor:
Lawrence X. Yu, Adam C. Fisher, Katherine M. Tyner, Sau L. Lee, N. Sarah Arden, Michael Kopcha
Publikováno v:
International Journal of Pharmaceutics. 602:120554
Over the last two centuries, medicines have evolved from crude herbal and botanical preparations into more complex manufacturing of sophisticated drug products and dosage forms. Along with the evolution of medicines, the manufacturing practices for t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::675b3cf2eb0bfc3949d78391f6408490
https://doi.org/10.1016/j.ijpharm.2021.120554
https://doi.org/10.1016/j.ijpharm.2021.120554