Results 51 to 60 of about 6,245 (194)

Population pharmacokinetics and pharmacodynamics of canagliflozin in paediatric patients with type 2 diabetes mellitus

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Canagliflozin was recently approved in type 2 diabetes mellitus (T2DM) patients ≥10 and <18 years old as a single agent dosed once daily (QD) or in a fixed‐dose combination with metformin dosed twice daily (BID). We characterize canagliflozin pharmacokinetics in paediatric patients with T2DM, compare estimated individual and simulated ...
Nele Goeyvaerts, Per Olsson Gisleskog, Martine Neyens, Juan José Perez Ruixo, Saberi Rana Ali, Iolanda Cirillo, Oliver Ackaert   +6 more
wiley   +1 more source

The Visual Predictive Check and Real‐World Data

Clinical Pharmacology &Therapeutics, EarlyView.
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

Tutorial on Causal Mediation Analysis for Pharmacometricians

CPT: Pharmacometrics & Systems Pharmacology
Mediation analyses can support biomarker development by quantifying the part of the total treatment effect on clinical outcome that is mediated by the biomarker.
Sebastiaan Camiel Goulooze, Eleonora Marostica, Nelleke Snelder   +2 more
doaj   +1 more source

Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis‐Associated Pain: An Application of Markov Model

CPT: Pharmacometrics & Systems Pharmacology, 2020
Elagolix is an oral gonadotropin‐releasing hormone antagonist approved by the US Food and Drug Administration (FDA) for the management of moderate‐to‐severe pain associated with endometriosis and in combination with estradiol/norethindrone acetate ...
Insa Winzenborg, Akshanth R. Polepally, Ahmed Nader, Nael M. Mostafa, Peter Noertersheuser, Juki Ng   +5 more
doaj   +1 more source

Population pharmacokinetics and standard uptake value ratio of aducanumab, an amyloid plaque–removing agent, in patients with Alzheimer’s disease

CPT: Pharmacometrics & Systems Pharmacology, 2022
Aducanumab is a human immunoglobulin G1 anti‐amyloid beta (Aβ) antibody currently being evaluated for potential treatment of patients with early Alzheimer’s disease.
Kumar Kandadi Muralidharan, Xiao Tong, Kenneth G. Kowalski, Raj Rajagovindan, Lin Lin, Samantha Budd Haberlain, Ivan Nestorov   +6 more
doaj   +1 more source

Scaling Approaches for Pediatric Dose Selection: The Fremanezumab (AJOVY^®) Journey to Select a Phase 3 Dose Using Pharmacokinetic Data from a Phase 1 Study

Pharmaceutics, 2021
Fremanezumab, a fully humanized IgG2Δa/kappa monoclonal antibody, selectively targets the calcitonin-gene-related peptide (CGRP) and prevents it from binding to the CGRP receptor.
Aksana Jones, Orit Cohen-Barak, Andrijana Radivojevic, Jill Fiedler-Kelly   +3 more
doaj   +1 more source

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

Clinical Pharmacology &Therapeutics, EarlyView.
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

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

Clinical Pharmacology &Therapeutics, EarlyView.
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

Evaluation of machine learning methods for covariate data imputation in pharmacometrics

CPT: Pharmacometrics & Systems Pharmacology, 2022
Missing data create challenges in clinical research because they lead to loss of statistical power and potentially to biased results. Missing covariate data must be handled with suitable approaches to prepare datasets for pharmacometric analyses, such as
Dominic Stefan Bräm, Uri Nahum, Andrew Atkinson, Gilbert Koch, Marc Pfister   +4 more
doaj   +1 more source

Clinical Model‐Informed Precision Dosing Consult Service for Accelerating Personalized Medication in Pediatric Patients

Clinical Pharmacology &Therapeutics, EarlyView.
Traditional dosing strategies often rely on a “one‐size‐fits‐all” paradigm, assuming an “average” patient with typical demographic and pharmacological characteristics. In reality, this often overlooks existing between‐patient variability and can lead to suboptimal drug exposure or toxicity. This issue is especially pronounced in pediatric patients, who
Zachary L. Taylor, Takanobu Nadai, Kei Irie, Wen Rui Tan, Sanjana Parikh, Anhar Hosawi, Matthijs W. van Hoogdalem, Ronaldo Morales Junior, Sonya Tang Girdwood, Abbie D. Leino, Kana Mizuno, Alexander A. Vinks, Tomoyuki Mizuno   +12 more
wiley   +1 more source