Zobrazeno 1 - 10
of 29
pro vyhledávání: '"Moheb Nasr"'
Autor:
Salvatore Mascia, Alastair J. Florence, Craig Johnston, Charles L. Cooney, Sau L. Lee, Bernhardt L. Trout, Yoshihiro Matsuda, Keith D. Jensen, Konstantin Konstantinov, Moheb Nasr, Markus Krumme, Clive Badman
Publikováno v:
Journal of Pharmaceutical Sciences. 106:3199-3206
Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is ba
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f71da7af463e3bdfb9863ebf59db460c
https://doi.org/10.1016/j.xphs.2017.06.015
https://doi.org/10.1016/j.xphs.2017.06.015
Autor:
Moheb Nasr, Alastair J. Florence, Charles L. Cooney, Markus Krumme, Bernhardt L. Trout, Salvatore Mascia, Konstantin Konstantinov, Clive Badman
Publikováno v:
Journal of pharmaceutical sciences. 108(11)
We make the case for why continuous pharmaceutical manufacturing is essential, what the barriers are, and how to overcome them. To overcome them, government action is needed in terms of tax incentives or regulatory incentives that affect time.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c018301801c52741ff184618759022db
https://pubmed.ncbi.nlm.nih.gov/31381905
https://pubmed.ncbi.nlm.nih.gov/31381905
Autor:
Pearle Torralba, Moheb Nasr, Elaine Gray, Roger L. Williams, Gyöngyi Gratzl, Edward K. Chess, Kristian Johansen, David A. Keire, Ali Al-Hakim, Anita Y. Szajek, Janet Woodcock, Christian Viskov, Jian Liu, Robert J. Linhardt, Zachary Shriver, Barbara Mulloy, Tina S. Morris, Wesley E. Workman
Publikováno v:
Nature Biotechnology. 34:625-630
The contamination of the widely used lifesaving anticoagulant drug heparin in 2007 has drawn renewed attention to the challenges that are associated with the characterization, quality control and standardization of complex biological medicines from n
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a9cafb0f3ae34d6bdb743c8a9ee29a09
https://doi.org/10.1038/nbt.3606
https://doi.org/10.1038/nbt.3606
Publikováno v:
Journal of Pharmaceutical Sciences. 104:832-839
This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cd1daae24d30d2f11d3ca0c4b5bf5b0b
https://doi.org/10.1002/jps.24311
https://doi.org/10.1002/jps.24311
Publikováno v:
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f8bb771f6889e4da0ab852a9a815c84d
https://doi.org/10.1002/9781119356189.ch2
https://doi.org/10.1002/9781119356189.ch2
Autor:
Oyvind Holte, Dora Kourti, Tara Gooen Bizjak, Rapti Madurawe, Elaine Morefield, Jean-Louis Robert, Nirdosh Jagota, Tom Garcia, William Randolph, Dave Rudd, Moheb Nasr, Charles L. Cooney, Frank Montgomery, Yanxi Tan Cain, Diane Zezza, Evdokia Korakianiti, Bekki Komas, Gretchen Allison
Publikováno v:
Continuous Manufacturing of Pharmaceuticals
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c5d628afb1207657cbc60319fd748dcb
https://doi.org/10.1002/9781119001348.ch3
https://doi.org/10.1002/9781119001348.ch3
Autor:
Hongping Ye, Ali Al-Hakim, Cynthia D. Sommers, Lucinda F. Buhse, Moheb Nasr, David A. Keire, Richard E. Kolinski
Publikováno v:
Analytical and Bioanalytical Chemistry. 401:2445-2454
We evaluated polyacrylamide gel electrophoresis (PAGE) and size exclusion chromatography coupled with multi-angle laser light scattering (SEC-MALLS) approaches to determine weight-average molecular weight (M w) and polydispersity (PD) of heparins. A
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ed9a56edf3e9b18db53e929e9f32fddc
https://doi.org/10.1007/s00216-011-5362-z
https://doi.org/10.1007/s00216-011-5362-z
Autor:
Shankar Srinivasan, Richard D. Wood, Moheb Nasr, William J. Welsh, David A. Keire, Qingda Zang, Syed Haque, Dinesh P. Mital, Michael L. Trehy, Christine M. V. Moore, Ali Al-Hakim, Lucinda F. Buhse
Publikováno v:
Analytical and Bioanalytical Chemistry. 401:939-955
Chemometric analysis of a set of one-dimensional (1D) (1)H nuclear magnetic resonance (NMR) spectral data for heparin sodium active pharmaceutical ingredient (API) samples was employed to distinguish USP-grade heparin samples from those containing ov
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3c80dd725cd4fec84677f4f2c1addfa3
https://doi.org/10.1007/s00216-011-5155-4
https://doi.org/10.1007/s00216-011-5155-4
Autor:
Michael L. Trehy, David A. Keire, Qingda Zang, Moheb Nasr, Richard D. Wood, Ali Al-Hakim, William J. Welsh, Lucinda F. Buhse, Christine M. V. Moore
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 54:1020-1029
Heparin is a naturally produced, heterogeneous compound consisting of variably sulfated and acetylated repeating disaccharide units. The structural complexity of heparin complicates efforts to assess the purity of the compound, especially when differ
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d25c8e4b23441e7b34aae7d4f8bb5a76
https://doi.org/10.1016/j.jpba.2010.12.008
https://doi.org/10.1016/j.jpba.2010.12.008
Publikováno v:
Analytical Chemistry. 82:9865-9870
Here we report results from the analyses by enzymatic digestion and reversed-phase ion-pairing liquid chromatography mass spectrometry (RPIP-LC-MS) of active pharmaceutical ingredient (API) unfractionated heparins (UFHs) from six different manufactur
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0553b856a132508384ff5645e133a5e6
https://doi.org/10.1021/ac102301j
https://doi.org/10.1021/ac102301j