Shobha Purushothama

Bioanalysis of Antibody–Drug Conjugates: American Association of Pharmaceutical Scientists Antibody–Drug Conjugate Working Group Position Paper

Boris Gorovits, Stephen C. Alley, Sanela Bilic et al. · Bioanalysis · 2013 · 164 citations

American Association, Immunology, Medicinal Chemistry +17

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)

Steven P. Piccoli, Devangi Mehta, Alessandra Vitaliti et al. · Bioanalysis · 2019 · 92 citations · Full text

Evaluation of highly sensitive immunoassay technologies for quantitative measurements of sub-pg/mL levels of cytokines in human serum

David T Yeung, Shawn Ciotti, Shobha Purushothama et al. · Journal of Immunological Methods · 2016 · 67 citations

Inflammation, Allergy, Autoimmune Disease +11

Anti-drug Antibody Validation Testing and Reporting Harmonization

Heather Myler, João Pedras-Vasconcelos, Kelli R. Phillips et al. · The AAPS Journal · 2021 · 64 citations · Full text

Translational Medicine, Allergy, Preclinical Drug Evaluation +15

Parallelism: Considerations for The Development, Validation and Implementation of PK and Biomarker Ligand-Binding Assays

Lauren Stevenson, Shobha Purushothama · Bioanalysis · 2014 · 47 citations

Laboratory Protocol, Engineering, Molecular Biology +24