Publications by authors named "Eric Woolf"

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The Use of Surrogate Matrix for Calibrators in the Analysis of Dried Blood Samples - A Feasibility Study.
Dong Hun Lee, Iris Xie, Matthew Solomon, Ming Wang, Linlin Luo, Eric Woolf

AAPS J· April 2025

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Quantitation of anacetrapib in human and animal adipose by liquid chromatography with mass spectrometric detection.
Wei Fang, Cynthia M Chavez-Eng, Ryan W Lutz, Hankun Li, Jessica Schlegel, Eric Woolf

Bioanalysis· October 2024

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ICH M10 Bioanalytical Method Validation Guideline-1 year Later.
Faye Vazvaei-Smith, Enaksha Wickremsinhe, Eric Woolf, Chongwoo Yu

AAPS J· September 2024

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Cloud security in a bioanalytical world: considerations for use of third-party cloud services for bioanalysis.
Scott Davis, Shibani Mitra-Kaushik, Eric Woolf, John Evens, Michelle Dawes

Bioanalysis· December 2023

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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, Eric Woolf

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, Eric Woolf

Bioanalysis· May 2022

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Incorporating protein precipitation to resolve hybrid IP-LC-MS assay interference for ultrasensitive quantification of intact therapeutic insulin dimer in human plasma.
Li Sun, Yang Xu, Neal Dube, Melanie Anderson, Sheila Breidinger, Eric J Woolf

J Pharm Biomed Anal· April 2022

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A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials.
Marissa F Dockendorf, David Jaworowicz, Rebecca Humphrey, Melanie Anderson, Sheila Breidinger, Eric Woolf

AAPS J· April 2022

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An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat.
Melanie Anderson, Marissa F Dockendorf, Ian McIntosh, Iris Xie, Sheila Breidinger, Eric Woolf

AAPS J· April 2022

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Cloud solutions for GxP laboratories: considerations for data storage.
Scott Davis, Joel Usansky, Shibani Mitra-Kaushik, John Kellie, Kimberly Honrine, Eric Woolf

Bioanalysis· September 2021

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Provision of rapid and specific ex vivo diagnosis of central nervous system lymphoma from rodent xenograft biopsies by a fluorescent aptamer.
Joseph Georges, Xiaodong Qi, Xiaowei Liu, Yu Zhou, Eric C Woolf

J Neurosurg· June 2021

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Volumetric absorptive microsampling (VAMS®) in therapeutic protein quantification by LC-MS/MS: Investigation of anticoagulant impact on assay performance and recommendations for best practices in method development.
Xinliu Gao, Cindy Chen, Dong Geng, Kevin P Bateman, Shuangping Shi, Eric J Woolf

J Pharm Biomed Anal· March 2021

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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 ( - 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, Eric Woolf

Bioanalysis· February 2021

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The effectiveness of quality control samples in pharmaceutical bioanalysis.
Stephen Keller, Jorge Quiroz, Dave Christopher, Enaksha Wickremsinhe, Wanping Geng, Eric Woolf

Bioanalysis· February 2021

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A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs.
Kun Yang, Ying Zhang, Robert Chou, Lai Yeung, Simon Letarte, Eric Woolf

ACS Pharmacol Transl Sci· December 2020

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Clinical application of volumetric absorptive microsampling to the gefapixant development program.
Brad Roadcap, Azher Hussain, Dan Dreyer, Keynu Carter, Neal Dube, Eric Woolf

Bioanalysis· July 2020

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AAPS Workshop Report on ICH M10.
Brian Booth, Faye Vazvaei, Eric Fluhler, Heather Myler, Eric Woolf

AAPS J· December 2019

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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, Eric Woolf

Bioanalysis· December 2019

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Determination of doravirine in human plasma using liquid-liquid extraction and HPLC-MS/MS.
Rajesh Desai, Brad Roadcap, Dina Goykhman, Eric Woolf

Bioanalysis· August 2019

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Toward highly sensitive and reproducible LC-MS/MS analysis of MK-8591 phosphorylated anabolites in human peripheral blood mononuclear cells.
Li Sun, Cynthia Chavez-Eng, Kerry L Fillgrove, Bing Lu, Iris Xie, Eric J Woolf

Bioanalysis· February 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, Eric Woolf

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, Eric Woolf

Bioanalysis· November 2018

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Strategy for peptide quantification using LC-MS in regulated bioanalysis: case study with a glucose-responsive insulin.
Yang Xu, Dina Goykhman, Ming Wang, Tonya Jackson, Iris Xie, Eric J Woolf

Bioanalysis· August 2018

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Probe-based three-dimensional confocal laser endomicroscopy of brain tumors: technical note.
Evgenii Belykh, Arpan A Patel, Eric J Miller, Baran Bozkurt, Kaan Yağmurlu, Eric C Woolf

Cancer Manag Res· August 2018

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Extractability-mediated stability bias and hematocrit impact: High extraction recovery is critical to feasibility of volumetric adsorptive microsampling (VAMS) in regulated bioanalysis.
Iris Xie, Yang Xu, Melanie Anderson, Ming Wang, Lingling Xue, Eric J Woolf

J Pharm Biomed Anal· July 2018

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