2021 (1 POST)
Kimzey A , Mease K , Mounho-Zamora B, Wood M. 2021. 13. Biosimilar products—A review of past and current regulatory approval standards for preclinical safety studies. In: Translational Medicine : Optimising Preclinical Safety Evaluation of Biopharmaceuticals. CRC Press: Boca Raton, FL
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Topics: regulatory toxicology
2020 (1 POST)
Chesney A, Welsh B, Kimzey A , Lansita J. The process and challenges of deriving exposure-based limits for toxicological risk assessment for components and impurities present in cell therapy products with case studies. Poster for Society of Toxicology , Virtual Annual Meeting, 2020.
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Topics: Toxicology
2018 (1 POST)
Kimzey AL , Piche M-S, Wood M , Weir AB, Lansita J. 2018. 11.19 – Immunophenotyping in drug development. In: Comprehensive Toxicology, 3rd Ed. Vol 11:399–427 .
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Topics: Toxicology
2017 (2 POSTS)
Mease K , Kimzey A , Lansita J. 2017. Biomarkers for nonclinical infusion reactions in marketed biotherapeutics and considerations for study design. Curr Opin Toxicol 4(June):1–15; doi: 10.1016/j.cotox.2017.03.005 .
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Topics: biomarkers
Mease K, Kimzey A, Lansita J. Failed dose formulation analysis during a GLP study — Now what? Poster presented at Society of Toxicology 56th Annual Meeting, Baltimore, MD, March 2017.
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