Abbas Bandukwala

Statistics

Publications

Citations

323

H-Index

Active since

2019

Affiliations

United States Food and Drug Administration(Current)

Pfizer (United States)

GlaxoSmithKline (United States)

Regeneron (United States)

Bristol-Myers Squibb (United States)

Abbas Bandukwala is an author at United States Food and Drug Administration specializing in biomedical sciences, bioanalytical methodology, and biopharmaceutics.

Publications per year

2019–2024

Publications

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 ( Part 2 – 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 & Rare Matrices; Regulatory Inputs ( Part 1A – Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & 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 ( Part 2A –Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B –Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & 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 & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry ( Part 2 – Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)

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

Pharmacy, Biomedical Sciences, Biopharmaceutics +16

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