Zobrazeno 1 - 10
of 16
pro vyhledávání: '"Christine M V Moore"'
Autor:
Jieqiang Zhu, Xiaohui Fan, Yiyu Cheng, Rajiv Agarwal, Christine M V Moore, Shaw T Chen, Weida Tong
Publikováno v:
PLoS ONE, Vol 9, Iss 1, p e87462 (2014)
The overall control of the quality of botanical drugs starts from the botanical raw material, continues through preparation of the botanical drug substance and culminates with the botanical drug product. Chromatographic and spectroscopic fingerprinti
Externí odkaz:
https://doaj.org/article/1addb613c5744118a5ae49e6ded43797
Autor:
Raafat Fahmy, Bhaveshkumar H. Kothari, Stephen W. Hoag, Sharmista Chatterjee, Christine M. V. Moore, H. Gregg Claycamp
Publikováno v:
AAPS PharmSciTech. 19:3809-3828
The primary objective of this study was to compare two methods for establishing a design space for critical process parameters that affect ethylcellulose film coating of multiparticulate beads and assess this design space validity across manufacturin
Autor:
Raafat Fahmy, H. Gregg Claycamp, Stephen W. Hoag, Bhaveshkumar H. Kothari, Christine M. V. Moore, Sharmista Chatterjee
Publikováno v:
AAPS PharmSciTech. 18:1135-1157
The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process understanding and to identify critical process parameters for the manufacture of controlled release multiparticulate beads us
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:
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
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
Autor:
Ajit S. Shah, Thomas Rogers, James Murphy, Bruce E. Wise, D. Keith Anderson, Harish K. Santhanam, Mark A. Pietz, H. Peter Kleine, Derek B. Brown, V. H. Iskos, Jerry D. Clark, Melissa K. Lantz, Christine M. V. Moore, David V. Banaszak, Peter G. Ruminski, Czyzewski Ann M, Carlos A. Orihuela, Puneh S. Forouzi, Carl M. Knable, Gerald A. Weisenburger, Frank W. Muellner, Mark A. Lapack, Schilke Tobin C, Donald J. Gallagher, Albert D. Edeny, Ahmad Y. Sheikh
Publikováno v:
Organic Process Research & Development. 13:1088-1093
Studies directed toward the process research, development, and scale-up preparation of the potential αvβ3 integrin antagonist 1 are described. A convergent approach is detailed wherein tetrahydropyrimidine hydroxybenzoic acid 2 is linked to the β-
Autor:
Andre Raw, Filippos Kesisoglou, Lucinda F. Buhse, Russell Wesdyk, Sarah Pope Miksinski, E. J. Brandreth, Stephen P. F. Miller, Jeffrey Baker, Ashley Boam, Susan Rosencrance, Mohan Ganapathy, Sau L. Lee, Christine M. V. Moore, Gustavo Grampp, Robert Iser, Thomas Cosgrove, Gordon Johnston, Hayden Thomas, Paul Stinavage, David Doleski, Steven Kozlowski, Joerg Windisch, Emanuela Lacana, Lawrence X. Yu, Joseph Famulare, David Hussong, G. K. Raju, Mark Rosolowsky, S R Vaithiyalingam, Mansoor A. Khan, Susan C. Berlam, Lynne Ensor, Theresa Mullin
On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regul
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9aca655cbe6e3775e0f0ec8543d3f567
https://europepmc.org/articles/PMC4476989/
https://europepmc.org/articles/PMC4476989/
Autor:
Janet Woodcock, Celia N. Cruz, Thomas F. O’Connor, Xiaochuan Yang, Lawrence X. Yu, Sharmista Chatterjee, Sau L. Lee, Rapti D. Madurawe, Christine M. V. Moore
The Food and Drug Administration (FDA) regulates pharmaceutical drug products to ensure a continuous supply of high-quality drugs in the USA. Continuous processing has a great deal of potential to address issues of agility, flexibility, cost, and rob
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1b79ae0228c8d983f6174782d673bc91
https://zenodo.org/record/1232890
https://zenodo.org/record/1232890
Autor:
Edney Albert D, Carl M. Knable, Pierre-Jean Colson, D. Keith Anderson, Thomas Rogers, Donald J. Gallagher, Ajit S. Shah, H. Peter Kleine, Jerry D. Clark, James Murphy, Christine M. V. Moore, Neil Storer, Bruce E. Wise, Peter G. Ruminski, Gerald A. Weisenburger, Melissa K. Lantz
Publikováno v:
Organic Process Research & Development. 8:51-61
Described are four process research investigations directed toward discerning a scalable, enantioselective method for preparing (S)-β-amino acid ester 3, a key intermediate to the αvβ3 integrin antagonist 1. Reported are an asymmetric Michael reac