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A next generation mathematical model for the in vitro to clinical translation of T-cell engagers
In conclusion, the 2D model with trans-avidity to describe trimer formation is an improved approach for TCEs and is likely to produce more accurate predictions to support TCE development. (Source: Journal of Pharmacokinetics and Pharmacodynamics)
Source: Journal of Pharmacokinetics and Pharmacodynamics - February 15, 2023 Category: Drugs & Pharmacology Source Type: research

Mechanistic inference of the metabolic rates underlying $$^{13}$$ C breath test curves
AbstractCarbon stable isotope breath tests offer new opportunities to better understand gastrointestinal function in health and disease. However, it is often not clear how to isolate information about a gastrointestinal or metabolic process of interest from a breath test curve, and it is generally unknown how well summary statistics from empirical curve fitting correlate with underlying biological rates. We developed a framework that can be used to make mechanistic inference about the metabolic rates underlying a13C breath test curve, and we applied it to a pilot study of13C-sucrose breath test in 20 healthy adults. Starti...
Source: Journal of Pharmacokinetics and Pharmacodynamics - February 15, 2023 Category: Drugs & Pharmacology Source Type: research

Thanks to our Reviewers of 2022!
(Source: Journal of Pharmacokinetics and Pharmacodynamics)
Source: Journal of Pharmacokinetics and Pharmacodynamics - February 8, 2023 Category: Drugs & Pharmacology Source Type: research

The role of quantitative systems pharmacology in pharmacometrics and the scope of the journal
(Source: Journal of Pharmacokinetics and Pharmacodynamics)
Source: Journal of Pharmacokinetics and Pharmacodynamics - January 31, 2023 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetic comparability between two populations using nonlinear mixed effect models: a Monte Carlo study
Abstract‘Are two populations the same or are they different’ is a question that is often faced in clinical pharmacology trials e.g., a pharmacokinetic trial studying a particular drug in racially different groups. To address this question, concentration–time data were simulated from a reference and te st population, where in the latter the clearance, sample size, and sampling design were systematically varied. It was of interest to determine whether the estimates of clearance from the two groups were the same or different. Two approaches were used to estimate the empirical Bayes estimates (EBEs) for clearance. One ap...
Source: Journal of Pharmacokinetics and Pharmacodynamics - January 28, 2023 Category: Drugs & Pharmacology Source Type: research

Computing optimal drug dosing with OptiDose: implementation in NONMEM
AbstractDetermining a drug dosing recommendation with a PKPD model can be a laborious and complex task. Recently, an optimal dosing algorithm (OptiDose) was developed to compute the optimal doses for any pharmacometrics/PKPD model for a given dosing scenario. In the present work, we reformulate the underlying optimal control problem and elaborate how to solve it with standard commands in the software NONMEM. To demonstrate the potential of the OptiDose implementation in NONMEM, four relevant but substantially different optimal dosing tasks are solved. In addition, the impact of different dosing scenarios as well as the cho...
Source: Journal of Pharmacokinetics and Pharmacodynamics - January 27, 2023 Category: Drugs & Pharmacology Source Type: research

Changes in Associate Editors at the Journal of Pharmacokinetics and Pharmacodynamics
(Source: Journal of Pharmacokinetics and Pharmacodynamics)
Source: Journal of Pharmacokinetics and Pharmacodynamics - January 25, 2023 Category: Drugs & Pharmacology Source Type: research

Latent variable indirect response modeling of clinical efficacy endpoints with combination therapy: application to guselkumab and golimumab in patients with ulcerative colitis
This study aims to demonstrate that the latent variable IDR approach provides a convenient longitudinal exposure-response modeling framework to assess potential interaction effects of combination therapies. This is illustrated by an application to the exposure-response modeling of guselkumab, a monoclonal antibody in clinical development that blocks the interleukin-23p19 subunit, and golimumab, a monoclonal antibody that binds with high affinity to tumor necrosis factor-alpha. A Phase 2a study was conducted in 214 patients with moderate-to severe active ulcerative colitis for which longitudinal assessments of disease sever...
Source: Journal of Pharmacokinetics and Pharmacodynamics - January 17, 2023 Category: Drugs & Pharmacology Source Type: research

Investigating the contribution of residual unexplained variability components on bias and imprecision of parameter estimates in population pharmacokinetic mixed-effects modeling
AbstractIn a nonlinear mixed-effects modeling (NLMEM) approach of pharmacokinetic (PK) and pharmacodynamic (PD) data, two levels of random effects are generally modeled: between-subject variability (BSV) and residual unexplained variability (RUV). The goal of this simulation-estimation study was to investigate the extent to which PK and RUV model misspecification, errors in recording dosing and sampling times, and variability in drug content uniformity contribute to the estimated magnitude of RUV and PK parameter bias. A two-compartment model with first-order absorption and linear elimination was simulated as a true model....
Source: Journal of Pharmacokinetics and Pharmacodynamics - January 8, 2023 Category: Drugs & Pharmacology Source Type: research