A novel biomarker assay qualification strategy for rare human matrices – a case study of biomarkers in aqueous humor
Author:
Affiliation:
1. Bioanalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA, USA
Funder
Genentech
Publisher
Informa UK Limited
Link
https://www.tandfonline.com/doi/pdf/10.4155/bio-2023-0127
Reference24 articles.
1. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. US FDA, MD, USA. http://www.ncbi.nlm.nih.gov/books/NBK326791/
2. 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)
3. Biological Matrix Supply Chain Shortages: More Matrices Are Now Rare—the Case for Surrogate Matrices
4. Review of Biomarkers in Ocular Matrices: Challenges and Opportunities
5. Ocular bioanalysis: challenges and advancements in recent years for these rare matrices
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