Analytical Tools for Physicochemical Characterization and Fingerprinting

作者: David A. Keire

DOI: 10.1007/978-3-030-11751-1_6

关键词:

摘要: In this chapter, a broad overview of available tools for complex drug characterization will be provided. The focus on application existing high-resolution and high-sensitivity to drugs as fully validated quality assessment multiple product attributes needed assure safety efficacy. addition, an emergent technologies that could possibly provide improved data streams judge the molecules chapter present analytical methods can applied many classes. Only selected literature is cited where examples concepts described in text; not intended exhaustive review wide topic area.

参考文章(75)
Lucio Mauri, Giovanni Boccardi, Giangiacomo Torri, Michael Karfunkle, Eleonora Macchi, Laura Muzi, David Keire, Marco Guerrini, Qualification of HSQC methods for quantitative composition of heparin and low molecular weight heparins Journal of Pharmaceutical and Biomedical Analysis. ,vol. 136, pp. 92- 105 ,(2017) , 10.1016/J.JPBA.2016.12.031
Ian Jolliffe, Principal Component Analysis Encyclopedia of Statistics in Behavioral Science. ,(2005) , 10.1002/0470013192.BSA501
Yves Aubin, Derek J. Hodgson, William B. Thach, Geneviève Gingras, Simon Sauvé, Monitoring Effects of Excipients, Formulation Parameters and Mutations on the High Order Structure of Filgrastim by NMR. Pharmaceutical Research. ,vol. 32, pp. 3365- 3375 ,(2015) , 10.1007/S11095-015-1713-3
U. Holzgrabe, I. Wawer, B. Diehl, NMR spectroscopy in pharmaceutical analysis Elsevier. ,(2008)
Theodoros K. Karamanos, Arnout P. Kalverda, Gary S. Thompson, Sheena E. Radford, Mechanisms of amyloid formation revealed by solution NMR Progress in Nuclear Magnetic Resonance Spectroscopy. ,vol. 88, pp. 86- 104 ,(2015) , 10.1016/J.PNMRS.2015.05.002
Marco Guerrini, Timothy R. Rudd, Lucio Mauri, Eleonora Macchi, Jawed Fareed, Edwin A. Yates, Annamaria Naggi, Giangiacomo Torri, Differentiation of Generic Enoxaparins Marketed in the United States by Employing NMR and Multivariate Analysis Analytical Chemistry. ,vol. 87, pp. 8275- 8283 ,(2015) , 10.1021/ACS.ANALCHEM.5B01366
Hungyen Lin, Robert K. May, Michael J. Evans, Shuncong Zhong, Lynn F. Gladden, Yaochun Shen, J. Axel Zeitler, Robert K. May, Shuncong Zhong, Impact of Processing Conditions on Inter‐tablet Coating Thickness Variations Measured by Terahertz In‐Line Sensing Journal of Pharmaceutical Sciences. ,vol. 104, pp. 2513- 2522 ,(2015) , 10.1002/JPS.24503
James A Madsen, Victor Farutin, Theresa Carbeau, Steve Wudyka, Yan Yin, Stephen Smith, James Anderson, Ishan Capila, Toward the complete characterization of host cell proteins in biotherapeutics via affinity depletions, LC-MS/MS, and multivariate analysis mAbs. ,vol. 7, pp. 1128- 1137 ,(2015) , 10.1080/19420862.2015.1082017
Richard S Rogers, Nancy S Nightlinger, Brittney Livingston, Phil Campbell, Robert Bailey, Alain Balland, Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics mAbs. ,vol. 7, pp. 881- 890 ,(2015) , 10.1080/19420862.2015.1069454
Sarah Rogstad, Eric Pang, Cynthia Sommers, Meng Hu, Xiaohui Jiang, David A. Keire, Michael T. Boyne, Modern analytics for synthetically derived complex drug substances: NMR, AFFF–MALS, and MS tests for glatiramer acetate Analytical and Bioanalytical Chemistry. ,vol. 407, pp. 8647- 8659 ,(2015) , 10.1007/S00216-015-9057-8