Considerations on the Calculation of the Human Equivalent Dose from Toxicology Studies for Biologic Anticancer Agents

por Elmeliegy, Mohamed, Udata, Chandrasekhar, Liao, Ken, Yin, Donghua
Publicado 2021

A mechanistic pharmacokinetic model with drug and antidrug antibody interplay, and its application for assessing the impact of immunogenicity response on bioequivalence testing

por Liao, Kai H., Udata, Chandrasekhar, Yin, Donghua, Sewell, K. Lea, Kantaridis, Constantino, Alvarez, Daniel F., Meng, Xu
Publicado 2020

S204: SAFETY AND TOLERABILITY OF CAEL-101, AN ANTI-AMYLOID MONOCLONAL ANTIBODY, COMBINED WITH ANTI-PLASMA CELL DYSCRASIA THERAPY IN PATIENTS WITH LIGHT-CHAIN AMYLOIDOSIS: 18-MONTH...

por Valent, Jason, Liedtke, Michaela, Zonder, Jeffrey, Molina, Maria Angelica, Udata, Chandrasekhar, Ianus, Juliana, Tripptree, John, Catini, Julia, Quarta, C Cristina
Publicado 2023

Model-Based Characterization of the Pharmacokinetics, Target Engagement Biomarkers, and Immunomodulatory Activity of PF-06342674, a Humanized mAb Against IL-7 Receptor-α, in Adults...

por Williams, Jason H., Udata, Chandrasekhar, Ganguly, Bishu J., Bucktrout, Samantha L., Joh, Tenshang, Shannon, Megan, Wong, Gilbert Y., Levisetti, Matteo, Garzone, Pamela D., Meng, Xu
Publicado 2020