Publications by authors named "Joseph Marini"

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Control performance of the Extended Amphibian Metamorphosis Assay with the African clawed frog Xenopus laevis.
Katherine K Coady, Zhenglei Gao, Laurent Lagadic, Allen W Olmstead, Joseph Marini

Environ Toxicol Chem· December 2025

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Workshop Report: Scoping for the Development of a Proposal for an OECD Guidance Document on Fish Vitellogenin Assessment.
Natalie Burden, Catherine Aubee, Jacqueline Augusiak, Marta Baccaro, Svenja Boehler, Joseph Marini

Integr Environ Assess Manag· September 2025

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Evaluation of in vivo fish and amphibian endocrine test guideline assays: current status and future needs.
Natalie Burden, Constance A Mitchell, Zhichao Dang, Michelle R Embry, Scott Glaberman, Joseph Marini

Environ Toxicol Chem· June 2025

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Critical review of chronic toxicity testing approaches with the saltwater mysid (Americamysis bahia) used in pesticide registration.
Margaret Fleming, Jane Staveley, Alan Samel, John Aufderheide, T Michelle Blickley, Joseph Marini

Environ Toxicol Chem· April 2025

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Historical control histopathology data from amphibian metamorphosis assays and fathead minnow fish short term reproductive assays: A tool for data interpretation.
Jeffrey C Wolf, John W Green, Valentin Mingo, Joseph P Marini, Suzanne Z Schneider

Aquat Toxicol· February 2024

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An Amphibian Metamorphosis Assay Dietary Restriction Study: Lessons for Data Interpretation.
Joseph P Marini, Jeffrey C Wolf, Valentin Mingo, Lee E Sayers, Stephanie Y Jamieson

Environ Toxicol Chem· May 2023

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Population-level variation in parasite resistance due to differences in immune initiation and rate of response.
Amanda K Hund, Lauren E Fuess, Mariah L Kenney, Meghan F Maciejewski, Joseph M Marini

Evol Lett· April 2022

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Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs.
Francesca Civoli, Aparna Kasinath, Xiao-Yan Cai, Meenu Wadhwa, Andrew Exley, Joseph Marini

AAPS J· December 2019

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Comparison of Immunoassays for Measuring Serum Levels of Golimumab and Antibodies Against Golimumab in Ulcerative Colitis: A Retrospective Observational Study.
Anne-Emmanuelle Berger, Gerard Duru, Annick de Vries, Joseph C Marini, Djamila Aoucheta

Ther Drug Monit· August 2019

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Immunogenicity of Guselkumab Is Not Clinically Relevant in Patients with Moderate-to-Severe Plaque Psoriasis.
Yaowei Zhu, Joseph C Marini, Michael Song, Bruce Randazzo, Yaung-Kaung Shen

J Invest Dermatol· August 2019

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2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Lauren Stevenson, Susan Richards, Renuka Pillutla, Albert Torri, John Kamerud, Joseph Marini

Bioanalysis· December 2018

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An open-label, single-dose, phase 1 study of the absorption, metabolism and excretion of quizartinib, a highly selective and potent FLT3 tyrosine kinase inhibitor, in healthy male subjects, for the treatment of acute myeloid leukemia.
Madhu Sanga, Joyce James, Joseph Marini, Guy Gammon, Christine Hale

Xenobiotica· October 2017

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The nuclear hormone receptor gene Nr2c1 (Tr2) is a critical regulator of early retina cell patterning.
Ana Maria Olivares, Yinan Han, David Soto, Kyle Flattery, Joseph Marini

Dev Biol· September 2017

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Corrigendum to "The Nuclear Hormone Receptor Nr2c1 (Tr2) is a critical regulator of early retina cell pattering" [Dev. Biol. 16 (2017) 30797-7].
Ana Maria Olivares, Yinan Han, David Soto, Kyle Flattery, Joseph Marini

Dev Biol· September 2017

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Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments.
Rebecca G Watson, Adrienne Clements-Egan, Allen Schantz, Mark Ware, Bonnie Wu, Joseph C Marini

Bioanalysis· September 2017

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Erratum to: Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments.
Joseph C Marini, Michael Anderson, Xiao-Yan Cai, John Chappell, Todd Coffey

AAPS J· May 2017

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Comparisons of Serum Infliximab and Antibodies-to-Infliximab Tests Used in Inflammatory Bowel Disease Clinical Trials of Remicade®.
Joseph C Marini, Jocelyn Sendecki, Freddy Cornillie, John W Popp, Shawn Black

AAPS J· January 2017

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Pharmacokinetics and immunogenicity investigation of a human anti-interleukin-17 monoclonal antibody in non-naïve cynomolgus monkeys.
Chao Han, George R Gunn, Joseph C Marini, Gopi Shankar, Helen Han Hsu

Drug Metab Dispos· May 2015

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Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments.
Joseph C Marini, Michael Anderson, Xiao-Yan Cai, John Chappell, Todd Coffey

AAPS J· November 2014

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A phase 1, randomized study to assess the pharmacokinetic comparability of siltuximab derived from two different cell lines in healthy subjects.
Chao Xu, Chao Han, Joseph Marini, Joyce Ford, Stanley Marciniak

Clin Pharmacol Drug Dev· July 2014

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Comparison of the pharmacokinetics of subcutaneous ustekinumab between Chinese and non-Chinese healthy male subjects across two Phase 1 studies.
Yaowei Zhu, Qingmin Wang, Bart Frederick, Esther Bouman-Thio, Joseph C Marini

Clin Drug Investig· April 2013

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Mini Focus: bioanalysis of biosimilars.
Lakshmi Amaravadi, Joseph Marini

Bioanalysis· March 2013

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Preclinical evaluation of the metabolism and disposition of RRx-001, a novel investigative anticancer agent.
Jan Scicinski, Bryan Oronsky, Michael Taylor, Gang Luo, Timothy Musick, Joseph Marini

Drug Metab Dispos· September 2012

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Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-in-human study.
Zhenhua Xu, Esther Bouman-Thio, Craig Comisar, Bart Frederick, Bart Van Hartingsveldt, Joseph C Marini

Br J Clin Pharmacol· August 2011

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2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.
Natasha Savoie, Fabio Garofolo, Peter van Amsterdam, Surendra Bansal, Chris Beaver, Joseph C Marini

Bioanalysis· December 2010

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