Anna Edmison

2018 White Paper on Recent Issues in Bioanalysis: <i>‘A Global Bioanalytical Community Perspective on Last Decade of Incurred Samples Reanalysis (ISR)’</i> (Part 1 – Small Molecule Regulated Bioanalysis, Small Molecule Biomarkers, Peptides &amp; Oligonucleotide Bioanalysis)

Jan Welink, Yuanxin Xu, Eric Yang et al. · Bioanalysis · 2018 · 37 citations · Full text

2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( <u>Part 1</u> –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 et al. · Bioanalysis · 2021 · 32 citations

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( <u>Part 2</u> – 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 et al. · Bioanalysis · 2019 · 31 citations · Full text

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 &amp; Rare Matrices; Regulatory Inputs ( <u>Part 1A</u> – Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC &amp; <u>Part 1B</u> - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene &amp; Cell Therapy and Vaccine)

Surinder Kaur, Stephen C. Alley, Matt Szapacs et al. · Bioanalysis · 2022 · 26 citations

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( <u>Part 2A</u> –Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation &amp; Innovation <u>Part 2B</u> –Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene &amp; Cell Therapy and Vaccine)

Susan Spitz, Yan Zhang, Sally Fischer et al. · Bioanalysis · 2021 · 24 citations