Publications by authors named "Stephen Vinter"

Claim this Profile
2
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, Stephen Vinter

Bioanalysis· March 2025

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
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, Stephen Vinter

Bioanalysis· August 2023

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
T
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.
Ni A Khin, Cheryl Grandinetti, Hayley Dixey, Bei Yu, Rachel Skeete, Stephen Vinter

Clin Pharmacol Ther· July 2022

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
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, Stephen Vinter

Bioanalysis· May 2022

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
C
Conduct of remote inspections: challenges and progress.
Jason Wakelin-Smith, Stephen Vinter

Bioanalysis· December 2021

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Susan Spitz, Yan Zhang, Sally Fischer, Kristina McGuire, Ulrike Sommer, Stephen Vinter

Bioanalysis· March 2021

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( - 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).
Hendrik Neubert, Stephen C Alley, Anita Lee, Wenying Jian, Michael Buonarati, Stephen Vinter

Bioanalysis· February 2021

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
D
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.
Ni A Khin, Gail Francis, Jean Mulinde, Cheryl Grandinetti, Rachel Skeete, Stephen Vinter

Clin Pharmacol Ther· November 2020

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
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, Stephen Vinter

Bioanalysis· December 2019

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
V
Variations in internal standard: an inspector's perspective.
Stephen Vinter

Bioanalysis· September 2019

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
C
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

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
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, Stephen Vinter

Bioanalysis· December 2018

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
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, Stephen Vinter

Bioanalysis· November 2018

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
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, Stephen Vinter

Bioanalysis· December 2017

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
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, Stephen Vinter

Bioanalysis· November 2017

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).
An Song, Anita Lee, Fabio Garofolo, Surinder Kaur, Jeff Duggan, Stephen Vinter

Bioanalysis· December 2016

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).
Jan Welink, Eric Fluhler, Nicola Hughes, Mark Arnold, Fabio Garofolo, Stephen Vinter

Bioanalysis· September 2016

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis
2
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).
Brad Ackermann, Hendrik Neubert, Nicola Hughes, Fabio Garofolo, Lee Abberley, Stephen Vinter

Bioanalysis· December 2015

Social Media Activity not collected for this article yet.

Sign Up to Request Social Media Analysis