Results 81 to 90 of about 17,314,856 (225)

Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science

Clinical Pharmacology &Therapeutics, EarlyView.
New Approach Methodologies (NAMs) represent a paradigm shift in drug development and regulatory science, offering human‐relevant alternatives to traditional preclinical models. This mini‐review highlights recent advances in NAM development, validation, and regulatory application from FDA's Division of Applied Regulatory Science (DARS).
Ksenia Blinova, Kimberly Chiu, Anik Chaturbedi, Jahan Cooper, Tromondae K. Feaster, Paula L. Hyland, Lidiya Stavitskaya, Wendy W. Wu, Jeffry Florian, Rodney Rouse   +9 more
wiley   +1 more source

In vitro microphysiological system for modeling vascular disease [PDF]

, 2018
In vitro microphysiological system utilizes engineered tissue constructs from human cells to model functional activity of human tissues or organs in both healthy and diseased state, thereby providing a more accurate drug screening than animal models ...
Ji, Hayeun
core   +1 more source

Modeling lung endothelial dysfunction in sepsis‐associated ARDS using a microphysiological system

Physiological Reports
Endothelial dysfunction is a critical feature of acute respiratory distress syndrome (ARDS) associated with higher disease severity and worse outcomes. Preclinical in vivo models of sepsis and ARDS have failed to yield useful therapies in humans, perhaps
Nai‐Wen Liang, Carole Wilson, Brooke Davis, Ian Wolf, Tonela Qyli, Joy Moy, David J. Beebe, Lynn M. Schnapp, Sheena C. Kerr, Hilary E. Faust   +9 more
doaj   +1 more source

Vascular Microphysiological System for Investigating Endothelial Barrier Function During Organ Preservation and Reperfusion. [PDF]

Small
Endothelial cell damage after cold preservation and reperfusion injury causes deterioration of the endothelial barrier and ultimately results in edema, leading to transplant failure.
Kim Y, Goswami I, Gill E, Mahmoodi SR, Consiglio AN, Velazquez J, Nieman G, Alburo AAA, Woods B, Ellis BW, Filz von Reiterdank I, Uygun K, Uygun BE, Rubinsky B, Healy KE.   +14 more
europepmc   +2 more sources

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

Physiome-on-a-Chip: The Challenge of “Scaling” in Design, Operation, and Translation of Microphysiological Systems [PDF]

, 2015
Scaling of a microphysiological system (MPS) or physiome-on-a-chip is arguably two interrelated, modeling-based activities: on-platform scaling and in vitro-in vivo translation.
Stokes, CL, Cirit, Murat, Lauffenburger, Douglas A   +2 more
core   +1 more source

Radiation Exposure Induced Blood–Brain Barrier Injury via Mitochondria‐Mediated Sterile Inflammation

Advanced Science
Radiation‐induced brain injury (RIBI) is caused by exposure to high doses of ionizing radiation and characterized by severe cognitive dysfunction and brain necrosis. However, the pathogenesis of RIBI is not fully understood, and no effective intervention
Peng Wang, Jiayue Liu, Min Zhang, Juan Yang, Peihan Lian, Xiu Cheng, Jianhua Qin   +6 more
doaj   +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

Microphysiological systems [PDF]

APL Bioengineering, 2019
James J. Hickman, Dongeun Huh, Roger D. Kamm   +2 more
openaire   +3 more sources

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