Strategies for clinical dose optimization of T cell-engaging therapies in oncology

K Ball, SJ Dovedi, P Vajjah, A Phipps - MAbs, 2023 - Taylor & Francis
Innovative approaches in the design of T cell-engaging (TCE) molecules are ushering in a
new wave of promising immunotherapies for the treatment of cancer. Their mechanism of …

Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial …

S Glatt, D Baeten, T Baker, M Griffiths… - Annals of the …, 2018 - ard.bmj.com
Objective Interleukin (IL)-17A has emerged as pivotal in driving tissue pathology in immune-
mediated inflammatory diseases. The role of IL-17F, sharing 50% sequence homology and …

First‐in‐human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL‐17A and IL‐17F, in mild psoriasis

S Glatt, E Helmer, B Haier… - British journal of …, 2017 - Wiley Online Library
Aims To assess safety, pharmacokinetics (PK) and clinical efficacy of bimekizumab (formerly
UCB4940), a novel humanized monoclonal antibody and dual inhibitor of interleukin (IL) …

Does age affect gastric emptying time? A model‐based meta‐analysis of data from premature neonates through to adults

JJ Bonner, P Vajjah, K Abduljalil… - … & drug disposition, 2015 - Wiley Online Library
Purpose. Gastric emptying (GE) is often reported to be slower and more irregular in
premature neonates than in older children and adults. The aim of this study was to …

[HTML][HTML] Bimekizumab, a novel humanized IgG1 antibody that neutralizes both IL-17A and IL-17F

R Adams, A Maroof, T Baker, ADG Lawson… - Frontiers in …, 2020 - frontiersin.org
Interleukin (IL)-17A is a key driver of inflammation and the principal target of anti-IL-17
therapeutic monoclonal antibodies. IL-17A, and its structurally similar family member IL-17F …

[HTML][HTML] Randomized study of the safety and pharmacodynamics of inhaled interleukin-13 monoclonal antibody fragment VR942

G Burgess, M Boyce, M Jones, L Larsson, MJ Main… - …, 2018 - thelancet.com
Abstract Background Interleukin-13 (IL-13) is a key mediator of T-helper-cell-type-2 (Th-2)-
driven asthma, the inhibition of which may improve treatment outcomes. We examined the …

A generalisation of T‐optimality for discriminating between competing models with an application to pharmacokinetic studies

P Vajjah, SB Duffull - Pharmaceutical statistics, 2012 - Wiley Online Library
The T‐optimality criterion is used in optimal design to derive designs for model selection. To
set up the method, it is required that one of the models is considered to be true. We term this …

Introduction to pharmacokinetics in clinical toxicology

P Vajjah, GK Isbister, SB Duffull - Computational Toxicology: Volume I, 2012 - Springer
In clinical toxicology, a better understanding of the pharmacokinetics of the drugs may be
useful in both risk assessment and formulating treatment guidelines for patients …

Precision criteria to derive sample size when designing pediatric pharmacokinetic studies: Which measure of variability should be used?

F Salem, K Ogungbenro, P Vajjah… - The Journal of …, 2014 - Wiley Online Library
A new approach for calculation of sample size in pediatric clinical pharmacokinetic studies
was suggested based on desired precision for a pharmacokinetic parameter of interest. The …

A reduction in between subject variability is not mandatory for selecting a new covariate

CV Lagishetty, P Vajjah, SB Duffull - Journal of pharmacokinetics and …, 2012 - Springer
Population pharmacokinetic-pharmacodynamic analysis involves nonlinear hierarchical
modelling where the mean response in a population and the variability in response from …