Stephen Vinter - Novo Nordisk | 人才画像

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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 (part 1A - Recommendations on Advanced Strategies for Mass Spectrometry Assay..

John Wojcik,Timothy Sikorski,Jian Wang,Yue Huang, Hiroshi Sugimoto,Mike Baratta,Eugene Ciccimaro,Rachel Green,Wenying Jian,Sumit Kar,Yeoun Jin Kim,Michael Lassman, Susovan Mohapatra,Mark Qian,Anton I. Rosenbaum,Hetal Sarvaiya,Yu Tian,Inna Vainshtein,Long Yuan, Lin Tao,Allena Ji, Christopher Kochansky, Haibo Qiu, Estelle Maes,Lin-Zhi Chen, Megan Cooley,Dawn Dufield, Elizabeth Hyer,Jay Johnson,Wenkui Li, Aihua Liu, Yang Lu, John Meissen,Joe Palandra, Xiaonan Tang,Adam Vigil, Wei,Stephen Vinter,Yongjun Xue, Li Yang,Naiyu Zheng, Kimberly Benson,Fred Mccush, Zhenmin Liang,Lee Abberley,Matthew Andisik, Marcela Araya,Seongeun (Julia) Cho, Liliana Colligan,Arindam Dasgupta, Markus Dudek,Anna Edmison, Sally Fischer, Brian Folian,Fabio Garofolo,Akiko Ishii-Watabe, Dany Ivanova, Sonja Kwadijk-de Gijsel, Lina Luo, Michael Mcguinness, Christine O'Day, Reza Salehzadeh-Asl,Joao Tavares Neto,Tom Verhaeghe,Katty Wan,Emma Whale, Weili Yan,Eric Yang,Jinhui Zhang

BIOANALYSIS（2025）

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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, I..

Matt Szapacs,Wenying Jian,Daniel Spellman, Jennifer Cunliffe, Elizabeth Verburg,Surinder Kaur,John Kellie,Wenkui Li,John Mehl,Mark Qian,Xiazi Qiu,Federico Riccardi Sirtori,Anton I Rosenbaum, Tim Sikorski,Sekhar Surapaneni,Jian Wang,Amanda Wilson,Jinhui Zhang,Yongjun Xue,Noah Post,Yue Huang,Dina Goykhman,Long Yuan,Kasie Fang, Ellen Casavant,Linzhi Chen,Yunlin Fu, Ming Huang,Allena Ji,Jay Johnson,Michael Lassman,Jing Li,Ola Saad,Hetal Sarvaiya,Lin Tao,Yuting Wang,Naiyu Zheng,Arindam Dasgupta,Mohsen Rajabi Abhari,Akiko Ishii-Watabe,Yoshiro Saito, Dulcyane Neiva Mendes Fernandes,Joseph Bower,Chris Burns,Kevin Carleton,Seongeun Julia Cho,Xiulian Du,Marianne Fjording,Fabio Garofolo,Sumit Kar,Olga Kavetska,Elham Kossary,Yang Lu,Andrew Mayer,Nisha Palackal,Danielle Salha,Eric Thomas,Tom Verhaeghe,Stephen Vinter,Katty Wan,Yow-Ming Wang,Kathi Williams,Eric Woolf,Li Yang,Eric Yang,Abbas Bandukwala,Shirley Hopper,Kevin Maher,Joshua Xu,Eric Brodsky,Isabelle Cludts,Chad Irwin,Julie Joseph,Susan Kirshner,Mohanraj Manangeeswaran,Kimberly Maxfield,Joao Pedras-Vasconcelos,Therese Solstad,Seth Thacker,Omar Tounekti,Daniela Verthelyi,Meenu Wadhwa,Leslie Wagner,Takenori Yamamoto,Lucia Zhang, Lin Zhou

Bioanalysis（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 (part 1A-Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of L..

Surinder Kaur,Stephen C. Alley,Matt Szapacs,Amanda Wilson,Eugene Ciccimaro,Dian Su,Neil Henderson,Linzhi Chen,Fabio Garofolo,Shawna Hengel,Wenying Jian,John F. Kellie,Anita Lee,John Mehl,Joe Palandra, Haibo Qiu,Natasha Savoie,Diaa Shakleya,Ludovicus Staelens,Hiroshi Sugimoto,Giane Sumner,Jan Welink,Robert Wheller,Y-J Xue,Jianing Zeng,Jinhui Zhang, Huiyu Zhou,Jian Wang,Scott Summerfield,Olga Kavetska,Lieve Dillen,Ragu Ramanathan,Mike Baratta,Arindam Dasgupta,Anna Edmison,Luca Ferrari, Sally Fischer,Daniela Fraier,Sam Haidar, Kathrin Heermeier,Christopher James,Allena Ji,Lina Luo,Gustavo Mendes Lima Santos,Noah Post,Anton Rosenbaum,Sune Sporring,Sekhar Surapaneni,Stephen Vinter,Katty Wan,Eric Woolf,Seongeun (Julia) Cho,Elham Kossary,Sandra Prior,Mohsen Rajabi Abhari,Catherine Soo,Yow-Ming Wang,Abbas Bandukwala,Elana Cherry,Isabelle Cludts,Soma Ghosh,Shirley Hopper,Akiko Ishii-Watabe,Susan Kirshner,Kevin Maher,Kimberly Maxfield,Joao Pedras-Vasconcelos,Yoshiro Saito,Dean Smith,Therese Solstad,Daniela Verthelyi,Meenu Wadhwa,Leslie Wagner, Gunter Waxenecker,Haoheng Yan,Lucia Zhang

BIOANALYSIS（2022）

引用19浏览0WOS引用

Conduct of Remote Inspections: Challenges and Progress

Jason Wakelin-Smith,Stephen Vinter

Bioanalysis（2021）

引用3浏览0WOS引用

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, Innov..

BIOANALYSIS（2021）

引用25浏览0WOS引用

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,Kassa Ayalew, Mandy Budwal-Jagait,Seongeun-Julia Cho,Arindam Dasgupta,Andrew Fisher,Cynthia Kleppinger,Phillip D. Kronstein, Jennifer Martin, Michael McGuinness,Jean Mulinde,Stephen Vinter,Jason Wakelin-Smith, Paula Walker,Gail Francis

Clinical Pharmacology & Therapeuticsno. 1 (2021): 31-43

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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 B..

Susan Spitz,Yan Zhang, Sally Fischer,Kristina McGuire,Ulrike Sommer,Lakshmi Amaravadi,Abbas Bandukwala,Steven Eck,Fabio Garofolo,Rafiqul Islam,Gregor Jordan,Lindsay King,Yoshiro Saito,Giane Sumner,Linda Terry,Alessandra Vitaliti,Yow-Ming Wang,Christine Grimaldi,Alison Joyce,Rachel Palmer,Matthew Andisik, Marcela Araya,Mitra Azadeh,Daniel Baltrukonis,Rebecca Elliott,Sam Haidar,Seema Kumar,Andrew Mayer,Florian Neff,Nisha Palackal,Kun Peng,Mohsen Rajabi Abhari,Christina Satterwhite,Natasha Savoie,Catherine Soo,Stephen Vinter,Jan Welink,Weili Yan,Kevin Maher,David Lanham,Sylvie Bertholet,Naveen Dakappagari,Christele Gonneau,Cherie Green,Fabian Junker,Sumit Kar,Lisa Patti-Diaz,Shyam Sarikonda,Megan McCausland,Priscila Camillo Teixeira,Vilma Decman,Jose Estevam,Michael Hedrick,Alberto Hidalgo Robert,Gregory Hopkins,Sandra Nuti,Shabnam Tangri,Richard Wnek,Suman Dandamudi,Arindam Dasgupta,Anna Edmison,Patrick Faustino, Michael McGuinness,Gustavo Mendes Lima Santos,Tahseen Mirza,Diaa Shakleya,Susan Stojdl,Nilufer Tampal,Jinhui Zhang,Elana Cherry,Isabelle Cludts,Andrew Exley,Akiko Ishii-Watabe,Susan Kirshner,Joao Pedras-Vasconcelos,Meiyu Shen, Richard Siggers,Therese Solstad,Daniela Verthelyi,Haoheng Yan,Lucia Zhang

BIOANALYSIS（2021）

引用23浏览0WOS引用

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,Bei Yu,Kassa Ayalew,Seongeun-Julia Cho,Andrew Fisher,Cynthia Kleppinger,Ruben Ayala, Charles Bonapace,Arindam Dasgupta,Phillip D. Kronstein,Stephen Vinter

Clinical Pharmacology & Therapeutics（2020）

引用16浏览0WOS引用

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（2019）

引用2浏览0WOS引用

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)

Bioanalysis（2019）

引用25浏览0WOS引用

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