Publications by authors named "Seongeun J Cho"

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2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry ( - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV).
John Wojcik, Timothy Sikorski, Jian Wang, Yue Huang, Hiroshi Sugimoto, Seongeun Julia Cho

Bioanalysis· March 2025

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Remote Regulatory Assessments of Bioavailability/Bioequivalence Study Conduct by the Office of Study Integrity and Surveillance.
Monica Javidnia, Hasan A Irier, Sean Kassim, Seongeun Julia Cho

AAPS PharmSciTech· October 2024

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2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Mike Baratta, Wenying Jian, Shawna Hengel, Surinder Kaur, Jennifer Cunliffe, Seongeun Julia Cho

Bioanalysis· June 2024

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2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Matt Szapacs, Wenying Jian, Daniel Spellman, Jennifer Cunliffe, Elizabeth Verburg, Seongeun Julia Cho

Bioanalysis· August 2023

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2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC &  - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Surinder Kaur, Stephen C Alley, Matt Szapacs, Amanda Wilson, Eugene Ciccimaro, Seongeun Julia Cho

Bioanalysis· May 2022

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2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Brian Booth, Lauren Stevenson, Renuka Pillutla, Michael Buonarati, Chris Beaver, Seongeun Julia Cho

Bioanalysis· December 2019

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Crucial importance of evaluating internal standards (IS) response and troubleshooting in effective LCMS method development, validation and sample analysis.
Seongeun Julia Cho, Stephen Vinter, Fabio Garofolo

Bioanalysis· September 2019

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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).
Hendrik Neubert, Timothy Olah, Anita Lee, Stephanie Fraser, Robert Dodge, Seongeun Julia Cho

Bioanalysis· December 2018

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2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Jan Welink, Yuanxin Xu, Eric Yang, Amanda Wilson, Neil Henderson, Seongeun Julia Cho

Bioanalysis· November 2018

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2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
Hendrik Neubert, An Song, Anita Lee, Cong Wei, Jeff Duggan, Seongeun Julia Cho

Bioanalysis· December 2017

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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, Seongeun Julia Cho

Bioanalysis· December 2017

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2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).
Jan Welink, Eric Yang, Nicola Hughes, Brian Rago, Eric Woolf, Seongeun Julia Cho

Bioanalysis· November 2017

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Early cerebrovascular inflammation in a transgenic mouse model of Alzheimer's disease.
Dongzi Yu, Brian Corbett, Yaping Yan, Guang-Xian Zhang, Peter Reinhart, Seongeun J Cho

Neurobiol Aging· December 2012

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