Publications by authors named "David Keire"

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NMR-based structural integrity analysis of therapeutic monoclonal antibodies: a comparative study of Humira and its biosimilars.
Donna Baldisseri, Shen Luo, Christelle Anne F Ancajas, Uriel Ortega-Rodriguez, Christian Fischer, David Keire

MAbs· December 2025

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Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cell models.
Ji-Eun Seo, Hannah Xu, Xilin Li, Aisar H Atrakchi, Timothy McGovern, David A Keire

Regul Toxicol Pharmacol· November 2025

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The Role of Enhanced Analytical Procedure Development in Facilitating Post-Approval Changes Via Established Conditions.
Douglas Kirkpatrick, Nirzari Gupta, Ramesh Gopalaswamy, Rohit Kolhatkar, Morgan Hudson-Davis, David Keire

AAPS J· March 2025

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Nitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets.
Diaa Shakleya, Alaadin Alayoubi, Dustin Brown, Alaa Mokbel, Nicolas Abrigo, David Keire

Int J Pharm· December 2024

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Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells.
Xilin Li, Yuan Le, Xiaoqing Guo, Sruthi T King, Robert T Dorsam, David A Keire

Regul Toxicol Pharmacol· December 2024

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Optimizing the detection of N-nitrosamine mutagenicity in the Ames test.
Robert H Heflich, Michelle E Bishop, Roberta A Mittelstaedt, Jian Yan, Sharon K Guerrero, David A Keire

Regul Toxicol Pharmacol· November 2024

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An isocratic HPLC-UV analytical procedure for assessment of glutathione and its related substances.
Mary Schleiff, Jingfan Chen, Jingyue Yang, Cynthia Sommers, Xiaohui Shen, David Keire

J Pharm Biomed Anal· October 2024

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Analytical Procedure Development and Proposed Established Conditions: A Case Study of a Mass Spectrometry Based NDSRI Analytical Procedure.
Jinhui Zhang, Ramesh Raghavachari, Douglas C Kirkpatrick, David A Keire, Xiaoming Xu

J Pharm Sci· October 2024

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Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances.
Dongmei Lu, Bhagwant Rege, Andre Raw, Jingyue Yang, Khondoker Alam, David Keire

J Pharm Sci· September 2024

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Qualitative and quantitative analysis of glutathione and related impurities in pharmaceuticals by qNMR.
Qin Shu, Mary Schleiff, Cynthia Sommers, Jingyue Yang, Xiaohui Shen, David Keire

J Pharm Biomed Anal· May 2024

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Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets.
Diaa Shakleya, Bethel Asmelash, Alaadin Alayoubi, Nicolas Abrigo, Adil Mohammad, David Keire

J Pharm Sci· December 2023

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Performance Characteristics of Mass Spectrometry-Based Analytical Procedures for Quantitation of Nitrosamines in Pharmaceuticals: Insights from an Inter-laboratory Study.
Jingyue Yang, Raghavi Kakarla, Tim Marzan, Bill Sherwin, Mark George, David Keire

J Pharm Sci· October 2023

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Comprehensive N-Glycan Mapping using Parallel Reaction Monitoring LC-MS/MS.
Joshua Shipman, Cynthia Sommers, David A Keire, Kang Chen, Hongbin Zhu

Pharm Res· June 2023

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Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays.
Xilin Li, Yuan Le, Ji-Eun Seo, Xiaoqing Guo, Yuxi Li, David A Keire

Regul Toxicol Pharmacol· June 2023

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Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals.
Stephen Horne, Matthew D Vera, Laxma R Nagavelli, Vilayat A Sayeed, Laurel Heckman, David A Keire

J Pharm Sci· May 2023

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A Bioanalytical Method for Quantification of N-nitrosodimethylamine (NDMA) in Human Plasma and Urine with Different Meals and following Administration of Ranitidine.
Ryan De Palma, Vikram Patel, Jeffry Florian, David Keire, Daniela Selaya

J Pharm Sci· May 2023

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Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s.
Xilin Li, Xiaobo He, Yuan Le, Xiaoqing Guo, Matthew S Bryant, David A Keire

Arch Toxicol· November 2022

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N-Nitrosamines Impurities in Pharmaceuticals the Abrupt Challenges They Bring and Approaches to Tackle the Risk.
Justin Moser, David Keire, Jörg Schlingemann, Christoph Saal

J Pharm Sci· October 2022

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Multiphase Drug Distribution and Exchange in Oil-in-Water Nanoemulsion Revealed by High-Resolution F qNMR.
Deyun Wang, Jin H Park, Jiwen Zheng, Bing Cai, David A Keire

Mol Pharm· July 2022

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Correction: International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines.
David A Keire, Robert Bream, Uwe Wollein, Schmaler-Ripcke, Annette Burchardt

AAPS J· July 2022

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International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines.
David A Keire, Robert Bream, Uwe Wollein, Jeannette Schmaler-Ripcke, Annette Burchardt

AAPS J· April 2022

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Risk of N-Nitrosodimethylamine (NMDA) Formation With Ranitidine.
David G Strauss, Jeffry Florian, David Keire

JAMA· November 2021

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Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA): A Randomized Clinical Trial.
Jeffry Florian, Murali K Matta, Ryan DePalma, Victoria Gershuny, Vikram Patel, David Keire

JAMA· July 2021

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NMR Spectroscopy for Protein Higher Order Structure Similarity Assessment in Formulated Drug Products.
Deyun Wang, You Zhuo, Mike Karfunkle, Sharadrao M Patil, Cameron J Smith, David A Keire

Molecules· July 2021

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In Vitro Analysis of N-Nitrosodimethylamine (NDMA) Formation From Ranitidine Under Simulated Gastrointestinal Conditions.
Zongming Gao, Michael Karfunkle, Wei Ye, Tim Andres Marzan, Jingyue Yang, David A Keire

JAMA Netw Open· June 2021

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