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Stephen Vinter

2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 2 – Hybrid LBA/LCMS and Input from Regulatory Agencies)
2015 · Brad Ackermann, Hendrik Neubert, et al. · Bioanalysis · 57
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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)
2017 · Jan Welink, Eric Yang, et al. · Bioanalysis · 44
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2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV): (Part 2 – Hybrid LBA/LCMS and Input from Regulatory Agencies)
2016 · An Song, Anita Lee, et al. · Bioanalysis · 44
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2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 1 – Small Molecules by LCMS)
2015 · Jan Welink, Eric Fluhler, et al. · Bioanalysis · 43
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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)
2018 · Hendrik Neubert, Timothy Olah, et al. · Bioanalysis · 39
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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)
2018 · Jan Welink, Yuanxin Xu, et al. · Bioanalysis · 39
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2017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Regulatory Agencies’ Inputs)
2017 · Hendrik Neubert, An Song, et al. · Bioanalysis · 37
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2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( Part 1 –Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)
2021 · Hendrik Neubert, Stephen C Alley, et al. · Bioanalysis · 35
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)
2019 · Brian Booth, Lauren Stevenson, et al. · Bioanalysis · 33
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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 ( Part 1A – Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
2022 · Surinder Kaur, Stephen C Alley, et al. · Bioanalysis · 32
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop
2020 · Ni A. Khin, Gail Francis, et al. · Clinical Pharmacology & Therapeutics · 30
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( Part 2A –Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B –Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
2021 · Susan Spitz, Yan Zhang, et al. · Bioanalysis · 27
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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 ( Part 1A – Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
2023 · Matt Szapacs, Wenying Jian, et al. · Bioanalysis · 22
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK
2021 · Ni A. Khin, Cheryl Grandinetti, et al. · Clinical Pharmacology & Therapeutics · 16
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 ( Part 1A – Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis Part 1B - Regulatory Agencies’ Inputs on Regulated Bioanalysis/BMV)
2025 · John Wojcik, Timothy Sikorski, et al. · Bioanalysis · 11
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Variations in Internal Standard: An Inspector's Perspective
2019 · Stephen Vinter · Bioanalysis · 3
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Crucial Importance of Evaluating Internal Standards (IS) Response and Troubleshooting in Effective LCMS Method Development, Validation and Sample Analysis
2019 · Seongeun Julia Cho, Stephen Vinter, et al. · Bioanalysis · 3
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Works count: 17
Citation count: 515
H-index: 14
I10-index: 15
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