Sally Fischer

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 · 32 citations · Full text

Pharmacy, Biomedical Sciences, Biopharmaceutics +9

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 · 29 citations · Full text

Pharmacy, Biochemistry, Biomedical Sciences +15

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 · 26 citations · Full text

Pharmacy, Biomedical Sciences, Immunology +16

2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles <u>Part 2</u> – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development &amp; Validation; Emerging Technologies; Critical Reagents Deep Characterization

Giane Sumner, Steve Keller, James W. Huleatt et al. · Bioanalysis · 2023 · 13 citations

Pharmacy, Biomedical Sciences, Biotechnology +17

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 ( <u>Part 1A</u> – Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis <u>Part 1B</u> - Regulatory Agencies’ Inputs on Regulated Bioanalysis/BMV)

John Wojcik, Timothy W. Sikorski, Jian Wang et al. · Bioanalysis · 2025 · 10 citations · Full text

Pharmacy, Biochemistry, Biomedical Sciences +17