Publications by authors named "Xinping Fang"

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17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Regulatory Assessments, Shedding Assays by PCR, and Biomarker Tissue Assays.
Jennifer Zimmer, Mark O'dell, Derrick Johnson, Amanda Hays, Shashank Gorityala, Xinping Fang

Bioanalysis· June 2025

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Recommendations on biomarker assay validation (BAV) in tissues by GCC.
Moucun Yuan, Aihua Liu, Bin Xu, Kurt Sales, Shane Karnik, Xinping Fang

Bioanalysis· April 2025

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Recommendations on qPCR/ddPCR assay validation by GCC.
Mark Wissel, Martin Poirier, Christina Satterwhite, John Lin, Rafiq Islam, Xinping Fang

Bioanalysis· June 2022

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Recommendations on ELISpot assay validation by the GCC.
Rafiq Islam, Jennifer Vance, Martin Poirier, Jennifer Zimmer, Ardeshir Khadang, Xinping Fang

Bioanalysis· February 2022

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Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.
Joseph Bower, Jennifer Zimmer, Stacie McCown, Edward Tabler, Shane Karnik, Xinping Fang

Bioanalysis· April 2021

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GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.
Corey Nehls, Michael Buonarati, Stephanie Cape, Rafiq Islam, Christina Satterwhite, Xinping Fang

Bioanalysis· September 2019

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12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Chad Briscoe, Nicola Hughes, Roger Hayes, Rafiq Islam, Patrick Bennett, Xinping Fang

Bioanalysis· June 2019

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Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Rafiq Islam, Sumit Kar, Hanna Ritzén, Amanda Hays, Rabab Tayyem, Xinping Fang

Bioanalysis· April 2019

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11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
Rafiq Islam, Chad Briscoe, Joseph Bower, Stephanie Cape, Mark Arnold, Xinping Fang

Bioanalysis· April 2018

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9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.
Roger Hayes, Richard LeLacheur, Isabelle Dumont, Philippe Couerbe, Afshin Safavi, Xinping Fang

Bioanalysis· March 2016

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8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
Joseph Bower, Douglas Fast, Fabio Garofolo, Dominique Gouty, Roger Hayes, Xinping Fang

Bioanalysis· July 2015

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Mass balance and metabolism of the antimalarial pyronaridine in healthy volunteers.
Carrie A Morris, Stephen R Dueker, Peter N Lohstroh, Li-Quan Wang, Xin-Ping Fang

Eur J Drug Metab Pharmacokinet· March 2015

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7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.
Mario Rocci, Steve Lowes, Ronald Shoup, Fabio Garofolo, Raymond Farmen, Xinping Fang

Bioanalysis· October 2014

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Recommendations on incurred sample stability (ISS) by GCC.
Steve Lowes, Richard LeLacheur, Ronald Shoup, Fabio Garofolo, Isabelle Dumont, Xinping Fang

Bioanalysis· September 2014

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Ultrasensitive and automated 1 pg/ml fluticasone propionate assay in human plasma using LC-MS/MS.
Allena J Ji, Dawei Zhou, Shu Zhang, Monica Ann Cawley, Xinping Fang

Bioanalysis· February 2013

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Bioanalysis of drug in tissue: current status and challenges.
Y-J Xue, Hong Gao, Qin C Ji, Zamas Lam, Xinping Fang

Bioanalysis· November 2012

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Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars.
Robert Nicholson, Steve Lowes, Maria Cruz Caturla, Afshin Safavi, Dan Mamelak, Xinping Fang

Bioanalysis· October 2012

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Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).
Steve Lowes, Mark Boterman, Mira Doig, Massimo Breda, Jim Jersey, Xinping Fang

Bioanalysis· September 2012

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4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.
Steve Lowes, Jim Jersey, Ronald Shoup, Fabio Garofolo, Shane Needham, Xinping Fang

Bioanalysis· April 2012

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Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).
Mark Boterman, Mira Doig, Massimo Breda, Steve Lowes, Jim Jersey, Xinping Fang

Bioanalysis· March 2012

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Formation of a Global Contract Research Organization Council for Bioanalysis.
Noel Premkumar, Stephen Lowes, James Jersey, Fabio Garofolo, Isabelle Dumont, Xinping Fang

Bioanalysis· November 2010

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LC-MS/MS approach for quantification of therapeutic proteins in plasma using a protein internal standard and 2D-solid-phase extraction cleanup.
Ziping Yang, Michael Hayes, Xinping Fang, Michael P Daley, Seth Ettenberg

Anal Chem· December 2007

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Purification and characterization of an immunomodulatory Peptide from bovine placenta water-soluble extract.
Xin-Ping Fang, Wen-Shui Xia, Qing-Hai Sheng, Yu-Liang Wang

Prep Biochem Biotechnol· July 2007

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