Daniel Baltrukonis

Pharmacokinetics and pharmacodynamics of PF‐05231023, a novel long‐acting FGF21 mimetic, in a first‐in‐human study

Jennifer Dong, Michelle I. Rossulek, Veena Somayaji et al. · British Journal of Clinical Pharmacology · 2015 · 98 citations · Full text

Pharmacy, Pharmacokinetics, Pharmacology +13

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 · 95 citations · Full text

Pharmacy, Biomedical Sciences, Biopharmaceutics +13

Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics

Deborah Finco, Daniel Baltrukonis, Adrienne Clements‐Egan et al. · Journal of Pharmaceutical and Biomedical Analysis · 2010 · 46 citations

Pharmacy, Immunology, Monoclonal Antibodies +9

2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 &amp; CAR-T Immunogenicity; PCR &amp; Vaccine Assay Performance; ADA Assay Comparability &amp; Cut Point Appropriateness ( <u>Part 3</u> – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)

LiNa Loo, Shannon Harris, Mark Milton et al. · Bioanalysis · 2022 · 36 citations · Full text

Medicine, Biomedical Sciences, Biotechnology +16

Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study

Fred McCush, Ellen Wang, Carla Yunis et al. · The AAPS Journal · 2023 · 27 citations

Pharmacy, Immunology, Pharmacology +14