Abbas Bandukwala

Towards quality assurance and quality control in untargeted metabolomics studies

Richard D. Beger, Warwick B. Dunn, Abbas Bandukwala et al. · Metabolomics · 2019 · 149 citations · Full text

Life Sciences, Biochemistry, Bioinformatics +16

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

2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral &amp; Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry ( <u>Part 2</u> – Recommendations on Biomarkers/CDx Assays Development &amp; Validation, Cytometry Validation &amp; Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents &amp; Positive Controls Generation)

Sarah Hersey, Steve Keller, Joel Mathews et al. · Bioanalysis · 2022 · 25 citations · Full text

Pharmacy, Biomedical Sciences, Biopharmaceutics +16