Search Results - "Moore, Christine M. V."

Chemometric analysis for identification of botanical raw materials for pharmaceutical use: a case study using Panax notoginseng by Zhu, Jieqiang, Fan, Xiaohui, Cheng, Yiyu, Agarwal, Rajiv, Moore, Christine M V, Chen, Shaw T, Tong, Weida

“…The overall control of the quality of botanical drugs starts from the botanical raw material, continues through preparation of the botanical drug substance and…”
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A new chapter in pharmaceutical manufacturing: 3D-printed drug products by Norman, James, Madurawe, Rapti D., Moore, Christine M.V., Khan, Mansoor A., Khairuzzaman, Akm

“…FDA recently approved a 3D-printed drug product in August 2015, which is indicative of a new chapter for pharmaceutical manufacturing. This review article…”
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Identification of heparin samples that contain impurities or contaminants by chemometric pattern recognition analysis of proton NMR spectral data by Zang, Qingda, Keire, David A., Buhse, Lucinda F., Wood, Richard D., Mital, Dinesh P., Haque, Syed, Srinivasan, Shankar, Moore, Christine M. V., Nasr, Moheb, Al-Hakim, Ali, Trehy, Michael L., Welsh, William J.

“…Chemometric analysis of a set of one-dimensional (1D) 1 H nuclear magnetic resonance (NMR) spectral data for heparin sodium active pharmaceutical ingredient…”
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Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production by Lee, Sau L., O’Connor, Thomas F., Yang, Xiaochuan, Cruz, Celia N., Chatterjee, Sharmista, Madurawe, Rapti D., Moore, Christine M. V., Yu, Lawrence X., Woodcock, Janet

“…The Food and Drug Administration (FDA) regulates pharmaceutical drug products to ensure a continuous supply of high-quality drugs in the USA. Continuous…”
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A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process by Kothari, Bhaveshkumar H., Fahmy, Raafat, Claycamp, H. Gregg, Moore, Christine M. V., Chatterjee, Sharmista, Hoag, Stephen W.

“…ABSTRACT The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process understanding and to…”
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Comparing a Statistical Model and Bayesian Approach to Establish the Design Space for the Coating of Ciprofloxacin HCl Beads at Different Scales of Production by Kothari, Bhaveshkumar H., Fahmy, Raafat, Claycamp, H. Gregg, Moore, Christine M. V., Chatterjee, Sharmista, Hoag, Stephen W.

“…The primary objective of this study was to compare two methods for establishing a design space for critical process parameters that affect ethylcellulose film…”
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Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference by Yu, Lawrence X., Baker, Jeffrey, Berlam, Susan C., Boam, Ashley, Brandreth, E. J., Buhse, Lucinda, Cosgrove, Thomas, Doleski, David, Ensor, Lynne, Famulare, Joseph, Ganapathy, Mohan, Grampp, Gustavo, Hussong, David, Iser, Robert, Johnston, Gordon, Kesisoglou, Filippos, Khan, Mansoor, Kozlowski, Steven, Lacana, Emanuela, Lee, Sau L., Miller, Stephen, Miksinski, Sarah Pope, Moore, Christine M. V., Mullin, Theresa, Raju, G. K., Raw, Andre, Rosencrance, Susan, Rosolowsky, Mark, Stinavage, Paul, Thomas, Hayden, Wesdyk, Russell, Windisch, Joerg, Vaithiyalingam, Sivakumar

“…On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving…”
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Class Modeling Analysis of Heparin 1H NMR Spectral Data Using the Soft Independent Modeling of Class Analogy and Unequal Class Modeling Techniques by Zang, Qingda, Keire, David A, Wood, Richard D, Buhse, Lucinda F, Moore, Christine M. V, Nasr, Moheb, Al-Hakim, Ali, Trehy, Michael L, Welsh, William J

“…To differentiate heparin samples with varying amounts of dermatan sulfate (DS) impurities and oversulfated chondroitin sulfate (OSCS) contaminants, proton NMR…”
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Determination of galactosamine impurities in heparin samples by multivariate regression analysis of their ¹H NMR spectra by Zang, Qingda, Keire, David A, Wood, Richard D, Buhse, Lucinda F, Moore, Christine M. V, Nasr, Moheb, Al-Hakim, Ali, Trehy, Michael L, Welsh, William J

“…Heparin, a widely used anticoagulant primarily extracted from animal sources, contains varying amounts of galactosamine impurities. Currently, the United…”
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Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access by Algorri, Marquerita, Abernathy, Michael J, Cauchon, Nina S, Christian, Twinkle R, Lamm, Celeste Frankenfeld, Moore, Christine M V

“…The traditional paradigm for pharmaceutical manufacturing is focused primarily upon centralized facilities that enable mass production and distribution. While…”
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Determination of galactosamine impurities in heparin samples by multivariate regression analysis of their (1)H NMR spectra by Zang, Qingda, Keire, David A, Wood, Richard D, Buhse, Lucinda F, Moore, Christine M V, Nasr, Moheb, Al-Hakim, Ali, Trehy, Michael L, Welsh, William J

“…Heparin, a widely used anticoagulant primarily extracted from animal sources, contains varying amounts of galactosamine impurities. Currently, the United…”
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Combining (1)H NMR spectroscopy and chemometrics to identify heparin samples that may possess dermatan sulfate (DS) impurities or oversulfated chondroitin sulfate (OSCS) contaminants by Zang, Qingda, Keire, David A, Wood, Richard D, Buhse, Lucinda F, Moore, Christine M V, Nasr, Moheb, Al-Hakim, Ali, Trehy, Michael L, Welsh, William J

“…Heparin is a naturally produced, heterogeneous compound consisting of variably sulfated and acetylated repeating disaccharide units. The structural complexity…”
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Mass transport and chemical reaction in Taylor-vortex flows with entrained catalytic particles: applications to a novel class of immobilized enzyme biochemical reactors by Iosileviskii, G., Brenner, H., Moore, Christine M. V., Cooney, C. L.

“…The general problem of mass transport and chemical reaction in spatially periodic annular flows with entrained catalytic particles is in vestigated using…”
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Combining 1H NMR spectroscopy and chemometrics to identify heparin samples that may possess dermatan sulfate (DS) impurities or oversulfated chondroitin sulfate (OSCS) contaminants by Zang, Qingda, Keire, David A., Wood, Richard D., Buhse, Lucinda F., Moore, Christine M.V., Nasr, Moheb, Al-Hakim, Ali, Trehy, Michael L., Welsh, William J.

“…Heparin is a naturally produced, heterogeneous compound consisting of variably sulfated and acetylated repeating disaccharide units. The structural complexity…”
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Class Modeling Analysis of Heparin ^sup 1^H NMR Spectral Data Using the Soft Independent Modeling of Class Analogy and Unequal Class Modeling Techniques by Zang, Qingda, Keire, David A, Wood, Richard D, Buhse, Lucinda F, Moore, Christine M V, Nasr, Moheb, Al-Hakim, Ali, Trehy, Michael L, Welsh, William J

“…To differentiate heparin samples with varying amounts of dermatan sulfate (DS) impurities and oversulfated chondroitin sulfate (OSCS) contaminants, proton NMR…”
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Class Modeling Analysis of Heparin 1 H NMR Spectral Data Using the Soft Independent Modeling of Class Analogy and Unequal Class Modeling Techniques by Zang, Qingda, Keire, David A., Wood, Richard D., Buhse, Lucinda F., Moore, Christine M. V., Nasr, Moheb, Al-Hakim, Ali, Trehy, Michael L., Welsh, William J.

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Determination of galactosamine impurities in heparin samples by multivariate regression analysis of their 1H NMR spectra : Heparin Characterization by QINGDA ZANG, KEIRE, David A, WOOD, Richard D, BUHSE, Lucinda F, MOORE, Christine M. V, NASR, Moheb, AL-HAKIM, Ali, TREHY, Michael L, WELSH, William J

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Combining 1 H NMR spectroscopy and chemometrics to identify heparin samples that may possess dermatan sulfate (DS) impurities or oversulfated chondroitin sulfate (OSCS) contaminants by QINGDA ZANG, KEIRE, David A, WOOD, Richard D, BUHSE, Lucinda F, MOORE, Christine M. V, NASR, Moheb, AL-HAKIM, Ali, TREHY, Michael L, WELSH, William J

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Pilot Plant Preparation of an αvβ3 Integrin Antagonist. Part 1. Process Research and Development of a (S)-β-Amino Acid Ester Intermediate:  Synthesis via a Scalable, Diastereoselective Imino-Reformatsky Reaction by Clark, Jerry D, Weisenburger, Gerald A, Anderson, D. Keith, Colson, Pierre-Jean, Edney, Albert D, Gallagher, Donald J, Kleine, H. Peter, Knable, Carl M, Lantz, Melissa K, Moore, Christine M. V, Murphy, James B, Rogers, Thomas E, Ruminski, Peter G, Shah, Ajit S, Storer, Neil, Wise, Bruce E

“…Described are four process research investigations directed toward discerning a scalable, enantioselective method for preparing (S)-β-amino acid ester 3, a key…”
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Pilot-Plant Preparation of an α v β 3 Integrin Antagonist. Part 3. Process Research and Development of a Diisopropylcarbodiimide and Catalytic 1-Hydroxybenzotriazole Peptide Coupling by Clark, Jerry D., Anderson, D. Keith, Banaszak, David V., Brown, Derek B., Czyzewski, Ann M., Edeny, Albert D., Forouzi, Puneh S., Gallagher, Donald J., Iskos, V. H., Kleine, H. Peter, Knable, Carl M., Lantz, Melissa K., Lapack, Mark A., Moore, Christine M. V., Muellner, Frank W., Murphy, James B., Orihuela, Carlos A., Pietz, Mark A., Rogers, Thomas E., Ruminski, Peter G., Santhanam, Harish K., Schilke, Tobin C., Shah, Ajit S., Sheikh, Ahmad Y., Weisenburger, Gerald A., Wise, Bruce E.

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