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Papers共 12 篇Author StatisticsCo-AuthorSimilar Experts

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Pivotal Trial Characteristics and Types of Endpoints Used to Support Food and Drug Administration Rare Disease Drug Approvals Between 2013 and 2022
Kyungwan Hong, Bridget Nugent,Abbas Bandukwala,Robert Schuck, York Tomita, Salvatore Pepe, Mary Doi, Scott Winiecki, Kerry Jo Lee
CLINICAL TRIALS (2025)
Cited0Views0WOSBibtex
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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 (PART 1A – Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest ..
Mike Baratta,Wenying Jian,Shawna Hengel,Surinder Kaur, Jennifer Cunliffe,Jason Boer,Nicki Hughes,Sumit Kar,John F. Kellie,Yeoun Jin Kim,Michael E. Lassman,John T. Mehl,Ling Morgan,Joe Palandra,Hetal Sarvaiya,Jianing Zeng,Naiyu Zheng,Jian Wang,Long Yuan,Allena Ji, Christopher J. Kochansky, Lin Tao,Yue Huang, Estelle M. Maes, Luca Barbero,Kévin Contrepois,Luca Ferrari,Yunlin Fu,Jay S. Johnson,Barry R Jones, Monika Kansal, Lu Yang,Noah Post,Honglue Shen,Yongjun Xue, Yiyue Zhang, Gopa Roy Biswas,Seongeun Cho,Anna Edmison, Kimberly Benson,Lee Abberley,Mitra Azadeh, Jennifer Francis,Fabio Garofolo,Shalini Gupta, Iordanka Ivanova,Akiko Ishii‐Watabe,Shane Karnik,Sean Kassim,Olga Kavetska,Steve Keller,Elham Kossary,Wenkui Li,Fred McCush, Dulcyane Neiva Mendes,Mohsen Rajabi Abhari,Kara Scheibner,Timothy W. Sikorski,Roland F. Staack,Edward Tabler,Huaping Tang,Katty Wan,Yow‐Ming Wang,Emma Whale,Yang Li,Jennifer Zimmer,Abbas Bandukwala,Xiulian Du, Olga Kholmanskikh, Sonja Kwadijk‐de Gijsel,Meenu Wadhwa,Joshua Xu, Alessandra Buoninfante,Isabelle Cludts, Sandra S. Diebold,Kimberly Maxfield, Christian Mayer,João Pedras-Vasconcelos,Sophie Shubow,Yoïchi Tanaka,Omar Tounekti,Daniela Verthelyi,Leslie Wagner
Bioanalysisno. 9 (2024): 307-364
Cited1Views0Bibtex
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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）
Cited9Views0WOSBibtex
9
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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）
Cited23Views0WOSBibtex
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Author Statistics

#Papers: 12

#Citation: 202

H-Index: 7

G-Index: 9

Sociability: 6

Diversity: 1

Activity: 4

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