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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 Part 2 – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization
Giane Sumner, James W. Huleatt, Roland F. Staack, Leslie Wagner, Mitra Azadeh, Abbas Bandukwala, +62 more
16citations -
2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( PART 2A – Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) PART 2B – Regulatory Agencies’ Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)2025 Bioanalysis article Immunology and Microbiology Biosimilars and Bioanalytical Methods Open access
Nicoletta Bivi, Danielle L. Graham, Laura Joglekar, Kristina McGuire, Jeroen N. Stoop, Jad Zoghbi, +49 more
4citations -
Comparison of SERS spectral data sets of blood serum samples of hypopharyngeal cancer using silver and gold nanoparticles as substrates2026 Bioanalysis article Materials Science Gold and Silver Nanoparticles Synthesis and Applications Open access
Muhammad Muaz Tariq, Kashif Ali, Haq Nawaz, Muhammad Irfan Majeed, Nosheen Rashid, Allah Ditta, +7 more
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Label-free SERS for the detection of renal failure biomarkers in blood serum using gold nanoparticles as a substrate2026 Bioanalysis article Materials Science Gold and Silver Nanoparticles Synthesis and Applications Open access
Fozia Sarfraz, Misbah Naeem, Muhammad Irfan Majeed, Muhammad Zeeshan Majeed, Haq Nawaz, Nosheen Rashid, +9 more
0citations
6 results