Publications by authors named "Bruce Stouffer"

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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, Bruce Stouffer

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, Bruce Stouffer

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, Bruce Stouffer

Bioanalysis· April 2019

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Incurred sample reproducibility in pharmacokinetic bioanalysis: pros and cons from a CRO perspective.
Brittany Maria Timmons, Laura Hay, Jim Gorman, Bruce Stouffer

Bioanalysis· November 2018

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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, Bruce Stouffer

Bioanalysis· April 2018

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2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Shalini Gupta, Susan Richards, Lakshmi Amaravadi, Steven Piccoli, Binodh Desilva, Bruce Stouffer

Bioanalysis· December 2017

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The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.
Stephanie Cape, Rafiq Islam, Corey Nehls, John Allinson, Afshin Safavi, Bruce Stouffer

Bioanalysis· April 2017

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Old to new ligand-binding assay method modifications.
Bruce Stouffer, Dennis Stocker

Bioanalysis· July 2016

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2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).
Lakshmi Amaravadi, An Song, Heather Myler, Theingi Thway, Susan Kirshner, Bruce Stouffer

Bioanalysis· December 2015

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Quantitative determination of free/bound atazanavir via high-throughput equilibrium dialysis and LC-MS/MS, and the application in ex vivo samples.
Xiaohui Sophia Xu, Anne Rose, Roger Demers, Timothy Eley, John Ryan, Bruce Stouffer

Bioanalysis· August 2015

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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).
Eric Fluhler, Roger Hayes, Fabio Garofolo, Isabelle Dumont, Olivier Le Blaye, Bruce Stouffer

Bioanalysis· July 2015

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Selective reaction monitoring of negative electrospray ionization acetate adduct ions for the bioanalysis of dapagliflozin in clinical studies.
Qin C Ji, Xiaohui Xu, Eric Ma, Jane Liu, Shenita Basdeo, Bruce Stouffer

Anal Chem· March 2015

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Fit-for-purpose bioanalytical cross-validation for LC-MS/MS assays in clinical studies.
Xiaohui Xu, Qin C Ji, Mohammed Jemal, Carol Gleason, Jim X Shen, Bruce Stouffer

Bioanalysis· January 2013

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A validated enantioselective LC-MS/MS assay for the simultaneous determination of carvedilol and its pharmacologically active 4'-hydroxyphenyl metabolite in human plasma: application to a clinical pharmacokinetic study.
Michael T Furlong, Bing He, William Mylott, Song Zhao, Thomas Mariannino, Bruce Stouffer

J Pharm Biomed Anal· November 2012

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Addressing drug effects on cut point determination for an anti-drug antibody assay.
Maria D F S Barbosa, Carol R Gleason, Kelli R Phillips, Flora Berisha, Bruce Stouffer

J Immunol Methods· October 2012

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Overcoming bioanalytical challenges in an Onglyza(®) intravenous [(14)C]microdose absolute bioavailability study with accelerator MS.
Xiaohui Sophia Xu, Stephen R Dueker, Lisa J Christopher, Pete N Lohstroh, Chi Fung Anther Keung, Bruce Stouffer

Bioanalysis· August 2012

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Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix(®), a CTLA-4-Fc fusion protein, in renal and liver transplant patients.
Heather A Myler, Kelli R Phillips, Huijin Dong, Edward Tabler, Mehmooda Shaikh, Bruce Stouffer

Bioanalysis· June 2012

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Liquid chromatography and tandem mass spectrometry method for the quantitative determination of saxagliptin and its major pharmacologically active 5-monohydroxy metabolite in human plasma: method validation and overcoming specific and non-specific binding at low concentrations.
Xiaohui Sophia Xu, Roger Demers, Huidong Gu, Lisa J Christopher, Hong Su, Bruce Stouffer

J Chromatogr B Analyt Technol Biomed Life Sci· March 2012

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A validated LC-MS/MS assay for the simultaneous determination of the anti-leukemic agent dasatinib and two pharmacologically active metabolites in human plasma: application to a clinical pharmacokinetic study.
Michael T Furlong, Shruti Agrawal, Dara Hawthorne, Michael Lago, Steve Unger, Bruce Stouffer

J Pharm Biomed Anal· January 2012

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The effects of age and gender on the pharmacokinetics and pharmacodynamics in healthy subjects of the plasminogen activator, lanoteplase.
Nimish N Vachharajani, Ralph H Raymond, Wen-Chyi Shyu, Bruce C Stouffer, David W Boulton

Br J Clin Pharmacol· November 2011

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Liquid chromatography and tandem mass spectrometry for the quantitative determination of ixabepilone (BMS-247550, Ixempra) in human plasma: method validation, overcoming curve splitting issues and eliminating chromatographic interferences from degradants.
Xiaohui Sophia Xu, Jianing Zeng, William Mylott, Mark Arnold, James Waltrip, Bruce Stouffer

J Chromatogr B Analyt Technol Biomed Life Sci· February 2010

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Comparison of pharmacokinetics of lanoteplase and alteplase during acute myocardial infarction.
John B Kostis, Randy C Dockens, Udho Thadani, Vasnath Bethala, Carl Pepine, Bruce C Stouffer

Clin Pharmacokinet· September 2002

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Effect of delivery route on pulmonary response to oncostatin M.
Hong Lan Li, Neil Mathias, Julita Timoszyk, Bruce Stouffer, Doris Wall

J Drug Target· February 2002

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