Results 51 to 60 of about 690 (120)

Validating Physiologically‐Based Pharmacokinetic Models Using the Continuous Ranked Probability Score: Beyond Being Correct on Average

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 2, February 2026.
ABSTRACT Physiologically‐based pharmacokinetic (PBPK) models have become increasingly popular for model‐informed drug development (MIDD) over the past decade. While several guidelines for model evaluation exist, these are by design often of a general and non‐specific nature. It is clear what steps should be carried out but not necessarily how.
Laurens Sluijterman, Marjolein van Borselen, Rick Greupink, Joanna IntHout   +3 more
wiley   +1 more source

A QSP Model of Valproic Acid Toxicity in Pediatric and Adult Populations: Implications for Formulation Selection and L‐Carnitine Supplementation

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 2, February 2026.
Schematic workflow of the QSP model development and application. The study builds upon an initial adult male model structure (top left) by integrating reported data on age‐related changes in elimination pathways (top right). This allowed for the extension of the QSP model to pediatric and female populations (bottom right), which was then used to ...
Alejandra Schiavo, Cecilia Maldonado, Marta Vázquez, Pietro Fagiolino, Inaki F. Trocóniz, Manuel Ibarra   +5 more
wiley   +1 more source

Population Pharmacokinetic/Pharmacodynamic Modeling of Donidalorsen, an Antisense Oligonucleotide in Development for Prophylaxis of Hereditary Angioedema

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 2, February 2026.
ABSTRACT Hereditary angioedema (HAE) is a rare disorder linked to kallikrein‐kinin system dysregulation, which leads to uncontrolled activation of plasma prekallikrein. Donidalorsen is an antisense oligonucleotide designed to selectively degrade prekallikrein messenger RNA and thereby reduce prekallikrein production.
John K. Diep, Miao Liu, Pratap Singh, Steve Dorow, Danny M. Cohn, Laura Bordone, Kenneth B. Newman, Xiang Gao   +7 more
wiley   +1 more source

Impact of Obesity and MASH on Zonal Hepatocellular Statin Exposure: Pharmacodynamic Insights From a Permeability‐Limited Multicompartment Liver Model

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 1, January 2026.
Obesity, MASH and Statins: Insights from a PBPK/PD Zonal Liver Model. ABSTRACT Statins are frequently prescribed for hyperlipidemia, a common comorbidity in patients with obesity and/or metabolic dysfunction‐associated steatohepatitis (MASH). However, limited knowledge exists on how MASH may alter statin disposition within hepatocytes where the statin ...
William A. Murphy, Noora Sjöstedt, Mailys De Sousa Mendes, Mattie Hartauer, Kim L. R. Brouwer, Sibylle Neuhoff   +5 more
wiley   +1 more source

Physiologically‐Based Pharmacokinetic Modeling of the PARP Inhibitor Niraparib

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 1, January 2026.
ABSTRACT A physiologically‐based pharmacokinetic (PBPK) model of niraparib and its primary metabolite using a relevant virtual cancer population is reported here. A series of in vitro experiments using liver S9, microsomes, and hepatocytes with various inhibitors and recombinant supersomes demonstrated that niraparib is specifically metabolized by ...
Gareth J. Lewis, Roxanne C. Jewell, Anu Shilpa Krishnatry, Kunal S. Taskar   +3 more
wiley   +1 more source

Managing Delayed or Missed Doses of Prolonged‐Release Tacrolimus in Transplant Recipients: Implications for Drug Exposure and Recovery Strategies

Basic &Clinical Pharmacology &Toxicology, Volume 138, Issue 1, January 2026.
This simulation–based analysis quantified the impact of delayed and missed doses of prolonged–release tacrolimus in kidney and liver transplant recipients. A single missed dose reduced AUC24h by up to 50% and required 2–4 days to return to steady state.
S. Arraki Zava, F. Maizaud, H. Sayadi, Y. Fromage, P. Marquet, J. B. Woillard, C. Monchaud   +6 more
wiley   +1 more source

Artificial Intelligence Meets Bioequivalence: Using Generative Adversarial Networks for Smarter, Smaller Trials

Machine Learning and Knowledge Extraction
This study introduces artificial intelligence as a powerful tool to transform bioequivalence (BE) trials. We apply advanced generative models, specifically Wasserstein Generative Adversarial Networks (WGANs), to create virtual subjects and reduce the ...
Anastasios Nikolopoulos, Vangelis D. Karalis   +1 more
doaj   +1 more source

Evolving Landscape of Precision Medicine in Bladder Cancer: From Challenges to Clinical Impact

iLABMED, Volume 3, Issue 4, Page 427-447, December 2025.
Evolving Landscape of Precision Medicine in Bladder Cancer. Image created with BioRender.com. ABSTRACT Bladder cancer (BCa) remains one of the most challenging urological malignancies to treat because of its marked molecular heterogeneity, high recurrence rates, and variable therapeutic responses.
Ting Ye, Javeria Qadir, Guangjie Peng, Liyuan Liu, Liang Cheng   +4 more
wiley   +1 more source

Bioequivalence Studies of Highly Variable Drugs: An Old Problem Addressed by Artificial Neural Networks

Applied Sciences
The bioequivalence (BE) of highly variable drugs is a complex issue in the pharmaceutical industry. The impact of this variability can significantly affect the required sample size and statistical power.
Dimitris Papadopoulos, Georgia Karali, Vangelis D. Karalis   +2 more
doaj   +1 more source

PRT to predict pharmacokinetic profiles as part of a bioequivalence study of the drug deferasirox

Разработка и регистрация лекарственных средств
Introduction. Deferasirox is a complexing drug and belongs to class II according to the biopharmaceutical classification system (BCS), has acidic properties and belongs to subclass “a” (acid).
A. V. Suvorova, P. A. Losenkova, Yu. V. Medvedev, E. A. Malashenko, I. E. Makarenko, A. M. Poluyanov, I. E. Shohin   +6 more
doaj   +1 more source