Publications by authors named "Michael Moxness"

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Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics.
Marisa K Joubert, Meghana Deshpande, Jane Yang, Helen Reynolds, Christine Bryson, Michael Moxness

PLoS One· August 2017

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A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab.
Primal Kaur, Vincent Chow, Nan Zhang, Michael Moxness, Arunan Kaliyaperumal

Ann Rheum Dis· March 2017

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Comparison of pharmacokinetics and safety of pegfilgrastim administered by two delivery methods: on-body injector and manual injection with a prefilled syringe.
Bing-Bing Yang, Phuong Khanh Morrow, Xikun Wu, Michael Moxness, Desmond Padhi

Cancer Chemother Pharmacol· June 2015

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Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact.
Suzanna M Tatarewicz, Daniel T Mytych, Marta Starcevic Manning, Steven J Swanson, Michael S Moxness

Bioanalysis· June 2014

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Epitope characterization of pre-existing and developing antibodies to an aglycosylated monoclonal antibody therapeutic of G1m17,1 allotype.
Suzanna M Tatarewicz, Gloria Juan, Steven J Swanson, Michael S Moxness

J Immunol Methods· August 2012

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Summary of confirmation cut point discussions.
Holly W Smith, Michael Moxness, Robin Marsden

AAPS J· June 2011

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Bioanalytical considerations in the comparability assessment of biotherapeutics.
Jean W Lee, Yow-Ming Wang, Michael Moxness, Binodh DeSilva

Bioanalysis· March 2011

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Rheumatoid factor interference in immunogenicity assays for human monoclonal antibody therapeutics.
Suzanna Tatarewicz, Jill M Miller, Steven J Swanson, Michael S Moxness

J Immunol Methods· May 2010

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Comparing exponentially weighted moving average and run rules in process control of semiquantitative immunogenicity immunoassays.
Troy E Barger, Lei Zhou, Michael Hale, Michael Moxness, Steven J Swanson

AAPS J· March 2010

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A step-wise approach for transfer of immunogenicity assays during clinical drug development.
Suzanna Tatarewicz, Michael Moxness, Dohan Weeraratne, Lei Zhou, Michael Hale

AAPS J· September 2009

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Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.
Gopi Shankar, Viswanath Devanarayan, Lakshmi Amaravadi, Yu Chen Barrett, Ronald Bowsher, Michael Moxness

J Pharm Biomed Anal· December 2008

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Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
Eugen Koren, Holly W Smith, Elizabeth Shores, Gopi Shankar, Deborah Finco-Kent, Michael Moxness

J Immunol Methods· April 2008

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Six-month continuous intraputamenal infusion toxicity study of recombinant methionyl human glial cell line-derived neurotrophic factor (r-metHuGDNF in rhesus monkeys.
David N Hovland, Robert B Boyd, Mark T Butt, Jeffery A Engelhardt, Michael S Moxness

Toxicol Pathol· December 2007

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Development of a maturing T-cell-mediated immune response in patients with idiopathic Parkinson's disease receiving r-metHuGDNF via continuous intraputaminal infusion.
Suzanna M Tatarewicz, Xin Wei, Shalini Gupta, Donna Masterman, Steven J Swanson, Michael S Moxness

J Clin Immunol· November 2007

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Six-month continuous intraputamenal infusion toxicity study of recombinant methionyl human glial cell line-derived neurotrophic factor (r-metHuGDNF) in rhesus monkeys.
David N Hovland, Robert B Boyd, Mark T Butt, Jeffery A Engelhardt, Michael S Moxness

Toxicol Pathol· August 2007

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Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies.
Michael Moxness, Suzanna Tatarewicz, Dohan Weeraratne, Nancy Murakami, Danika Wullner

Clin Chem· October 2005

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Cerebrospinal fluid ACTH and cortisol in opsoclonus-myoclonus: effect of therapy.
Michael R Pranzatelli, Kelly Y Chun, Michael Moxness, Elizabeth D Tate, Tyler J Allison

Pediatr Neurol· August 2005

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