Results 81 to 90 of about 8,980,611 (179)

Chemical Distribution Kinetics of Five Polycyclic Aromatic Hydrocarbons in a Microphysiological System

Toxics
As next-generation risk assessment accelerates the shift towards non-animal models, it also necessitates the development of tools that quantify the chemical in vitro distribution to derive an effective concentration.
Katharina S. Nitsche, Susana Proença, Wouter Bakker, Paul L. Carmichael, Hans Bouwmeester, Nynke I. Kramer   +5 more
doaj   +1 more source

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

Clinical 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

The ascendance of microphysiological systems to solve the drug testing dilemma

, 2017
The development of drugs is a process obstructed with manifold security and efficacy concerns. Although animal models are still widely used to meet the diligence required, they are regarded as outdated tools with limited predictability.
Eva-Maria Dehne, Tobias Hasenberg, Uwe Marx   +2 more
core   +1 more source

Human Vascular Microphysiological Systems for Drug Screening

, 2016
Endothelial dysfunction is the predominant pathophysiological state prior to the onset of atherosclerosis. Currently, treatments for endothelial dysfunction are evaluated in vitro using two-dimensional (2D) cell culture assays or in vivo animal models ...
Fernandez, Cristina Elena
core   +1 more source

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

Clinical 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, Sheng‐Ya Wang, Edward W. G. Ashton, Rosie K. Barrows, Molly Monks, Yuzhang Ge, Arthur Lefebvre, Steven A. Niederer   +7 more
wiley   +1 more source

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

Clinical 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, Gelareh Abulwerdi, Christin L. Daniels, Calib Choi, Rebecca Racz, Jean‐Pierre Valentin, Kristin Ardlie, Nicholas Tatonetti, Susan Laffan, Marjory Moreau, Will Redfern, Lang Li, James J. Hickman, Rajanikanth Madabushi, Bhagwat Prasad, Lynne Yao, Paul B. Watkins   +16 more
wiley   +1 more source

Engineering human peritoneum in vitro: A novel microfluidic platform for modeling peritoneal physiology and pathophysiology

Bioengineering & Translational Medicine
The peritoneum, the body's largest serous membrane, plays critical roles in abdominal homeostasis and immune defense. When disrupted by surgery or disease, it can lead to devastating complications including peritoneal adhesions—affecting up to 93% of ...
Katharina Peisert, Franziska Keßler, Sara Y. Brucker, Jan Pauluschke‐Fröhlich, Peter Jakubowski, Felix Neis, Bernhard Krämer, Jürgen Andress, Adrian Weghofer, Hui‐Yu Liu, Peter Loskill, Martin Weiss   +11 more
doaj   +1 more source

Emerging Human‐Based Research Technologies for Investigating the Pathomechanisms and Therapies for Vascular Diseases

iNew Medicine, EarlyView.
ABSTRACT It is estimated that a large proportion of drug candidates fail in human clinical trials, mainly because animal models cannot fully replicate human disease and because of differential responses to various medications between humans and animals.
Weiping Ding, Iqra Ilyas, Suowen Xu
wiley   +1 more source

Modular and Intermediate Instrumented Cell Culture Platforms: Bridging the Gap Between Conventional Dishes and Complex Microphysiological Systems

This scoping review aims to map and synthesize the available evidence regarding the development, architectural characteristics, and application of technological bridging platforms—such as modular intermediated systems—used to connect or transition from ...
Nathalia Sernizon Guimarães, Antonio Rogerio Dias Guimaraes, Julliane Vasconcelos Joviano dos Santos   +2 more
core   +6 more sources

Paediatric developmental safety and the ICH E11A extrapolation of safety

British Journal of Clinical Pharmacology, EarlyView.
Gilbert J. Burckart, Susan M. Abdel‐Rahman, Gelareh Abulwerdi, Rebecca Racz, Sherbet Samuels, Dionna J. Green, Lynne P. Yao   +6 more
wiley   +1 more source