Carol Gleason

机构：Bristol-Myers Squibb (United States)

发表论文 53 篇 · 总被引 1478 次 · h-index 21

代表论文

• 2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62) (2019 · Bioanalysis · 被引 95)
• Anti-drug Antibody Validation Testing and Reporting Harmonization (2021 · The AAPS Journal · 被引 76)
• Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development (2015 · The AAPS Journal · 被引 76)
• 2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 1 – Small Molecules by LCMS) (2015 · Bioanalysis · 被引 42)
• Anti-Peg Antibody Bioanalysis: A Clinical Case Study with Peg-Ifn-λ-1A and Peg-Ifn-α2A in Naive Patients (2015 · Bioanalysis · 被引 33)
• A systematic study of the effect of low pH acid treatment on anti-drug antibodies specific for a domain antibody therapeutic: Impact on drug tolerance, assay sensitivity and post-validation method assessment of ADA in clinical serum samples (2017 · Journal of Immunological Methods · 被引 26)