Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics
Jenkins, Rand, Duggan, Jeffrey X., Aubry, Anne-Françoise, Zeng, Jianing, Lee, Jean W., Cojocaru, Laura, Dufield, Dawn, Garofolo, Fabio, Kaur, Surinder, Schultz, Gary A., Xu, Keyang, Yang, Ziping, Yu, John, Zhang, Yan J., Vazvaei, Faye
Published in The AAPS journal (01.01.2015)
Published in The AAPS journal (01.01.2015)
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Journal Article
Quantification of uric acid, xanthine and hypoxanthine in human serum by HPLC for pharmacodynamic studies
Cooper, Nancy, Khosravan, Reza, Erdmann, Carol, Fiene, John, Lee, Jean W.
Published in Journal of chromatography. B, Analytical technologies in the biomedical and life sciences (06.06.2006)
Published in Journal of chromatography. B, Analytical technologies in the biomedical and life sciences (06.06.2006)
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Journal Article
Fit-for-purpose method development and validation for successful biomarker measurement
LEE, Jean W, DEVANARAYAN, Viswanath, ROGERS, James A, MILLHAM, Robert, O'BRIEN, Peter J, SAILSTAD, Jeff, KHAN, Masood, RAY, Chad, WAGNER, John A, BARRETT, Yu Chen, WEINER, Russell, ALLINSON, John, FOUNTAIN, Scott, KELLER, Stephen, WEINRYB, Ira, GREEN, Marie, DUAN, Larry
Published in Pharmaceutical research (01.02.2006)
Published in Pharmaceutical research (01.02.2006)
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Journal Article
Simultaneous Analysis of Multiple Monoclonal Antibody Biotherapeutics by LC-MS/MS Method in Rat Plasma Following Cassette-Dosing
Li, Hongyan, Ortiz, Robert, Tran, Linh T. B., Salimi-Moosavi, Hossein, Malella, Jennifer, James, Christopher A., Lee, Jean W.
Published in The AAPS journal (01.04.2013)
Published in The AAPS journal (01.04.2013)
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Journal Article
Pharmacokinetics, Excretion, and Mass Balance of Liposomal Amphotericin B (AmBisome) and Amphotericin B Deoxycholate in Humans
BEKERSKY, Ihor, FIELDING, Robert M, DRESSLER, Dawna E, LEE, Jean W, BUELL, Donald N, WALSH, Thomas J
Published in Antimicrobial Agents and Chemotherapy (01.03.2002)
Published in Antimicrobial Agents and Chemotherapy (01.03.2002)
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Journal Article
Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report
Lee, Jean W, Weiner, Russ S, Sailstad, Jeff M, Bowsher, Ronald R, Knuth, Dean W, O'Brien, Peter J, Fourcroy, Jean L, Dixit, Rakesh, Pandite, Lini, Pietrusko, Robert G, Soares, Holly D, Quarmby, Valerie, Vesterqvist, Ole L, Potter, David M, Witliff, James L, Fritche, Herbert A, O'Leary, Timothy, Perlee, Lorah, Kadam, Sunil, Wagner, John A
Published in Pharmaceutical research (01.04.2005)
Published in Pharmaceutical research (01.04.2005)
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Journal Article
Plasma Protein Binding of Amphotericin B and Pharmacokinetics of Bound versus Unbound Amphotericin B after Administration of Intravenous Liposomal Amphotericin B (AmBisome) and Amphotericin B Deoxycholate
BEKERSKY, Ihor, FIELDING, Robert M, DRESSLER, Dawna E, LEE, Jean W, BUELL, Donald N, WALSH, Thomas J
Published in Antimicrobial Agents and Chemotherapy (01.03.2002)
Published in Antimicrobial Agents and Chemotherapy (01.03.2002)
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Journal Article
A general approach for the quantitative analysis of bisphosphonates in human serum and urine by high-performance liquid chromatography/tandem mass spectrometry
Zhu, Lee S., Lapko, Veniamin N., Lee, Jean W., Basir, Yousef J., Kafonek, Chris, Olsen, Richard, Briscoe, Chad
Published in Rapid communications in mass spectrometry (01.01.2006)
Published in Rapid communications in mass spectrometry (01.01.2006)
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Journal Article
General LC-MS/MS Method Approach to Quantify Therapeutic Monoclonal Antibodies Using a Common Whole Antibody Internal Standard with Application to Preclinical Studies
Li, Hongyan, Ortiz, Robert, Tran, Linh, Hall, Michael, Spahr, Chris, Walker, Ken, Laudemann, John, Miller, Sterling, Salimi-Moosavi, Hossein, Lee, Jean W.
Published in Analytical chemistry (Washington) (07.02.2012)
Published in Analytical chemistry (Washington) (07.02.2012)
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Journal Article
Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development
Lee, Jean W., Kelley, Marian, King, Lindsay E., Yang, Jihong, Salimi-Moosavi, Hossein, Tang, Meina T., Lu, Jian-Feng, Kamerud, John, Ahene, Ago, Myler, Heather, Rogers, Cindy
Published in The AAPS journal (01.03.2011)
Published in The AAPS journal (01.03.2011)
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Journal Article
Biomarker Assay Translation from Discovery to Clinical Studies in Cancer Drug Development: Quantification of Emerging Protein Biomarkers
Lee, Jean W., Figeys, Daniel, Vasilescu, Julian
Published in Advances in Cancer Research (01.01.2007)
Published in Advances in Cancer Research (01.01.2007)
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Book Chapter
Journal Article
Chylomicron-Bound LPS Selectively Inhibits the Hepatocellular Response to Proinflammatory Cytokines
Kasravi, Behzad, M.D., Ph.D, Lee, Diana H., B.S, Lee, Jean W., B.S, Dada, Stephen, M.D, Harris, Hobart W., M.D., M.P.H
Published in The Journal of surgical research (01.05.2008)
Published in The Journal of surgical research (01.05.2008)
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Journal Article
Ligand-Binding Mass Spectrometry to Study Biotransformation of Fusion Protein Drugs and Guide Immunoassay Development: Strategic Approach and Application to Peptibodies Targeting the Thrombopoietin Receptor
Hall, Michael P., Gegg, Colin, Walker, Kenneth, Spahr, Christopher, Ortiz, Robert, Patel, Vimal, Yu, Steven, Zhang, Liana, Lu, Hsieng, DeSilva, Binodh, Lee, Jean W.
Published in The AAPS journal (01.12.2010)
Published in The AAPS journal (01.12.2010)
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Journal Article