Results 81 to 90 of about 6,306 (210)

The Visual Predictive Check and Real‐World Data

Clinical Pharmacology &Therapeutics, Volume 120, Issue 2, Page 394-398, August 2026.
The visual predictive check (VPC) is a standard tool for assessing pharmacometric model suitability, producing visualizations that compare observed data with simulated data such that both model structure and model variability terms can be assessed. However, real‐world data commonly reflect clinical decision‐making that adapts therapy in response to ...
Jasmine H. Hughes, Martin Bergstrand, Ron J. Keizer   +2 more
wiley   +1 more source

Anifrolumab Dose Regimen Selection for a Phase 3 Trial in Lupus Nephritis

Clinical Pharmacology &Therapeutics, Volume 120, Issue 2, Page 429-439, August 2026.
In patients with systemic lupus erythematosus (SLE), increased type I interferon signaling is associated with increased disease activity across organs, including in the kidney, which can cause lupus nephritis (LN). Anifrolumab, which abrogates type I interferon signaling, is an approved treatment for moderate to severe SLE.
Joachim Almquist, Yen Lin Chia, Raj Tummala, Lynn Bertagnolli, David Jayne, Weifeng Tang, Catharina Lindholm   +6 more
wiley   +1 more source

Covariate modeling in pharmacometrics: General points for consideration

CPT: Pharmacometrics & Systems Pharmacology
Modeling the relationships between covariates and pharmacometric model parameters is a central feature of pharmacometric analyses. The information obtained from covariate modeling may be used for dose selection, dose individualization, or the planning of
Kinjal Sanghavi, Jakob Ribbing, James A. Rogers, Mariam A. Ahmed, Mats O. Karlsson, Nick Holford, Estelle Chasseloup, Malidi Ahamadi, Kenneth G. Kowalski, Susan Cole, Essam Kerwash, Janet R. Wade, Chao Liu, Yaning Wang, Mirjam N. Trame, Hao Zhu, Justin J. Wilkins, for the ISoP Standards & Best Practices Committee   +17 more
doaj   +1 more source

Pharmacometrics models with hidden Markovian dynamics [PDF]

Journal of Pharmacokinetics and Pharmacodynamics, 2017
The aim of this paper is to provide an overview of pharmacometric models that involve some latent process with Markovian dynamics. Such models include hidden Markov models which may be useful for describing the dynamics of a disease state that jumps from one state to another at discrete times.
openaire   +3 more sources

A Review of Virtual Twins in Physiologically‐Based Pharmacokinetic Modeling and Simulation

Clinical Pharmacology &Therapeutics, Volume 120, Issue 2, Page 324-333, August 2026.
The novel application of Virtual Twins (VT) in PBPK (VT‐PBPK) presents the opportunity to advance precision dosing and accelerate the shift from one‐size‐fits‐all to targeted, individualized treatments. This review aims to: (1) critically evaluate existing research on the use of VTs in PBPK, (2) develop a conceptual definition of VT‐PBPK, (3) describe ...
Emily Mannix, Sam Mostafa, Amin Rostami‐Hodjegan, Thomas M. Polasek, Carl M. J. Kirkpatrick   +4 more
wiley   +1 more source

Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non‐Japanese Individuals

The Journal of Clinical Pharmacology, Volume 66, Issue 8, August 2026.
Abstract Evaluation of the pharmacokinetics (PK) of new drugs in Japanese individuals is regularly requested by the Japanese regulatory agency prior to participation in global clinical trials or for bridging approaches for regulatory approval. However, the need for PK assessments in the Japanese population may be less compelling for monoclonal ...
Paridhi Gupta, Ashish Sharma, Bernd Meibohm   +2 more
wiley   +1 more source

A Combined Modeling Approach to Predict the Effect of Gastric Emptying Delay on the Pharmacokinetics of Small Molecules

CPT: Pharmacometrics & Systems Pharmacology
Dulaglutide, a long‐acting glucagon‐like peptide‐1 (GLP‐1) receptor agonist, is approved for improving glycemic control and reducing cardiovascular risks in patients with type 2 diabetes mellitus (T2DM).
Maria M. Posada, Karen B. Schneck, Bridget L. Morse, Luc R. A. Rougee, Lai San Tham, Jessica F. Rehmel, Brian Thompson, Stephen D. Stamatis, Stephen D. Hall, Gemma L. Dickinson   +9 more
doaj   +1 more source

Differential Impact of Pharmacokinetic and Pharmacodynamic Variability on Response to Combination Therapy

Pharmacology Research &Perspectives, Volume 14, Issue 4, August 2026.
ABSTRACT Interindividual variability (IIV) in drug response complicates both fixed‐dose design and individualized therapy. Understanding how pharmacokinetic (PK) and pharmacodynamic (PD) processes jointly shape this variability is essential, particularly in combination therapy, where multiple interacting pathways influence outcomes. This study employed
Kuteesa R. Bisaso, Ronald Kadada Karyaburo, Jackson K. Mukonzo, Ene I. Ette   +3 more
wiley   +1 more source

Population pharmacokinetics and pharmacodynamics of nasal glucagon in patients with type 1 or 2 diabetes

CPT: Pharmacometrics & Systems Pharmacology
The objective was to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of glucagon after injectable or nasal administration and confirm the appropriate therapeutic dose of nasal glucagon (NG) for adult patients.
Douglas E. James, Tong Shen, Jeanne S. Geiser, Parag Garhyan, Emmanuel Chigutsa   +4 more
doaj   +1 more source