Results 81 to 90 of about 13,844,580 (194)

Making PBPK models more reproducible in practice [PDF]

open access: yes
Systems biology aims to understand living organisms through mathematically modeling their behaviors at different organizational levels, ranging from molecules to populations.
Mazurenko, Stanislav   +19 more
core   +1 more source

Transcriptomic Profiling of SLC and ABC Transporters in the Human Term Placenta

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Solute carriers (SLC) and ATP‐binding cassette (ABC) transporters are essential for placental solute exchange and fetal protection, yet their transcriptomic profiles in the human placenta remain poorly characterized. Although fetal sex influences placental development and function, its impact on transporter expression is unclear.
Elijah Marsh Jung   +12 more
wiley   +1 more source

From Prediction to Decision Making: PBPK and QSP as Regulatory‐Grade NAMs

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
New approach methodologies (NAMs) encompass a diverse and rapidly evolving set of experimental and computational tools designed to generate human‐relevant mechanistic data for use in drug development and regulatory decision making. Experimental NAMs provide insights into drug disposition, pharmacological activity, and disease biology that are difficult
Karen Rowland Yeo, Piet H. van der Graaf
wiley   +1 more source

In Silico Clinical Trials in Drug Development: Virtual Patients, Applications, and Regulatory Convergence

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Conventional clinical trials remain the benchmark for evaluating therapeutic safety and efficacy, yet they are constrained by escalating costs, withdrawal over the extended follow‐up periods, recruitment difficulties, ethical limits, and a restricted ability to characterize heterogeneous populations.
Maximilian Balmus   +7 more
wiley   +1 more source

PBPK Modeling of Lamotrigine and Efavirenz during Pregnancy: Implications for Personalized Dosing and Drug-Drug Interaction Management

open access: yesPharmaceutics
This study aimed to model the pharmacokinetics of lamotrigine (LTG) and efavirenz (EFV) in pregnant women using physiologically based pharmacokinetic (PBPK) and pregnancy-specific PBPK (p-PBPK) models.
Bárbara Costa   +2 more
doaj   +1 more source

Pediatric Developmental Safety Assessment and New Approach Methodologies: US FDA/Triangle CERSI Workshop Report

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Pediatric developmental safety assessment presents distinct challenges in drug development. Children undergo dynamic changes in organ systems and drug disposition pathways during development, and drug‐related effects may be delayed or manifested differently than in adults.
Gilbert J. Burckart   +16 more
wiley   +1 more source

Physiologically based pharmacokinetic (PBPK) model of enalapril

open access: yes
<p>This repository provides the enalapril physiologically based pharmacokinetic (PBPK) model.</p> <p>If you have any questions or problems please <a href="https://github.com/matthiaskoenig/enalapril-model/issues">open an issue</
König, Matthias, Palwankar, Shubhankar
core   +1 more source

The gut microbiome and drug‐resistant epilepsy: Microbiome–antiseizure medication interactions and implications for pharmacoresistance

open access: yesEpilepsia Open, EarlyView.
Abstract Drug‐resistant epilepsy (DRE) affects approximately one‐third of patients with epilepsy and represents a major unmet clinical need. While traditional hypotheses of pharmacoresistance have focused on alterations in drug targets, efflux transporter overexpression, and intrinsic disease severity, the gut microbiome has recently emerged as a ...
Khaled Zammar   +4 more
wiley   +1 more source

Rapid PBPK modeling with the httk model

open access: yes, 2018
A Course on Physiologically Based Pharmacokinetic (PBPK) Modeling Given at ScitoVation Nov ...
John Wambaugh (230167)
core   +1 more source

High‐Content Screening Comparison of 1R6F Cigarette Smoke Extract and Selected Heated Tobacco and Electronic Vapour Product Aerosol Extracts in Endothelial and Bronchial Epithelial Cell Models

open access: yesJournal of Applied Toxicology, EarlyView.
ABSTRACT Cigarettes induce oxidative stress and DNA damage, processes that contribute to cardiovascular and pulmonary disease. High content screening (HCS) is an increasingly valuable tool for comparative toxicology because it enables simultaneous quantification of multiple mechanistic endpoints at single‐cell resolution. In this study, HCS was used to
Edgar Trelles Sticken   +9 more
wiley   +1 more source

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