Results 11 to 20 of about 7,734 (200)

Advancing Regulatory Adoption of New Approach Methodologies. [PDF]

Clin Pharmacol Ther
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has a long history advancing new approach methodologies (NAMs). In collaboration with external organizations and other regulatory agencies, FDA supports continued development of NAMs for regulatory use.
Florian J, Chiu K, Racz R, Elmore CL, Seo SK, Blinova K, Wu WW, Rouse R.   +7 more
europepmc   +2 more sources

Distribution and health risk assessment of nitrosamines in drinking water in Shanghai

环境与职业医学, 2022
BackgroundNitrosamines (NAms) are highly carcinogenic and frequently detected in drinking water systems in China, indicating potential human health risk through drinking water.ObjectiveTo analyze the distribution of NAms in drinking water in Shanghai and
Hongquan CAI, Hailei QIAN, Zhiyi XUE, Saifeng PEI, Yun ZHANG, Chaoye SHEN   +5 more
doaj   +1 more source

Connecting the Dots in Education for Newly Arrived Migrant Students in Flanders

Education Sciences, 2022
All over Europe, the rapidly increasing number of newly arrived migrant students (NAMS) not only transformed countries into ethnically diverse societies but also led to various challenges for the educational system in general and its schools and teachers
Laura Thomas, Britt Adams, Laura Emery, Thibaut Duthois, Ruben Vanderlinde, Melissa Tuytens   +5 more
doaj   +1 more source

Profiling the Structural Determinants of Aryl Benzamide Derivatives as Negative Allosteric Modulators of mGluR5 by In Silico Study

Molecules, 2020
Glutamate plays a crucial role in the treatment of depression by interacting with the metabotropic glutamate receptor subtype 5 (mGluR5), whose negative allosteric modulators (NAMs) are thus promising antidepressants.
Yujing Zhao, Jiabin Chen, Qilei Liu, Yan Li   +3 more
doaj   +1 more source

Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science. [PDF]

Clin Pharmacol Ther
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).
Blinova K, Chiu K, Chaturbedi A, Cooper J, Feaster TK, Hyland PL, Stavitskaya L, Wu WW, Florian J, Rouse R.   +9 more
europepmc   +2 more sources

From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs. [PDF]

Clin Pharmacol Ther
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
Rowland Yeo K, van der Graaf PH.
europepmc   +2 more sources

RE-Place: A Unique Project Collecting Expertise on New Approach Methodologies

Frontiers in Pharmacology, 2022
By applying “New Approach Methodologies (NAMs)” based on innovative technologies such as computer modeling, high throughput testing, omics, and sophisticated cell cultures, the use of experimental animals in the life sciences can be reduced or sometimes ...
Mieke Van Mulders, Mieke Van Mulders, Nancy Liodo Missigba, Nancy Liodo Missigba, Birgit Mertens, Vera Rogiers   +5 more
doaj   +1 more source

RECONSTRUCCIÓN DE LA PRECIPITACIÓN ANUAL PARA LA REGIÓN ORIENTAL DEL ESTADO DE TLAXCALA

Revista Mexicana de Ciencias Forestales, 2018
Los anillos de crecimiento de Pinus cembroides se emplearon como proxy para reconstruir la variabilidad histórica de la precipitación anual durante 159 años (1850 a 2008) en la región oriental del estado de Tlaxcala.
Gabriel F. Cardoza Martínez, Julián Cerano Paredes, José Villanueva Díaz, Rosalinda Cervantes Martínez, Vidal Guerra de la Cruz, Juan Estrada Ávalos   +5 more
doaj   +1 more source

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

Clin Pharmacol Ther
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.
Burckart GJ, Abulwerdi G, Daniels CL, Choi C, Racz R, Valentin JP, Ardlie K, Tatonetti N, Laffan S, Moreau M, Redfern W, Li L, Hickman JJ, Madabushi R, Prasad B, Yao L, Watkins PB.   +16 more
europepmc   +2 more sources

The qEEG Signature of Selective NMDA NR2B Negative Allosteric Modulators; A Potential Translational Biomarker for Drug Development. [PDF]

PLoS ONE, 2016
The antidepressant activity of the N-methyl-D-aspartate (NMDA) receptor channel blocker, ketamine, has led to the investigation of negative allosteric modulators (NAMs) selective for the NR2B receptor subtype.
Deborah Keavy, Linda J Bristow, Digavalli V Sivarao, Margaret Batchelder, Dalton King, Srinivasan Thangathirupathy, John E Macor, Michael R Weed   +7 more
doaj   +1 more source