Results 141 to 150 of about 2,053,467 (177)

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

Advancing Regulatory Adoption of New Approach Methodologies

Clinical Pharmacology &Therapeutics, EarlyView.
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.
Jeffry Florian, Kimberly Chiu, Rebecca Racz, C. Lee Elmore, Shirley K. Seo, Ksenia Blinova, Wendy W. Wu, Rodney Rouse   +7 more
wiley   +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

Urogenital Infection Risk Associated With SGLT2 Inhibitors Versus DPP‐4 Inhibitors in Type 2 Diabetes and Chronic Kidney Disease: A Nationwide Target Trial Emulation

Clinical Pharmacology &Therapeutics, EarlyView.
Although sodium‐glucose cotransporter‐2 inhibitors (SGLT2i) are recommended for patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), concerns regarding urogenital infections persist. Therefore, we evaluated the risk of urinary tract infection (UTI) and genital tract infection (GTI) after SGLT2i initiation in this population ...
Young‐Mi Ah, Junsung Nam, Jung Wook Youn, Yun Mi Yu, Soyoung Kang   +4 more
wiley   +1 more source

Climate Vulnerability and Sovereign ESG Performance: The Conditioning Roles of Adaptation Innovation, Institutional Quality and Robot Adoption

Corporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT The intensification of physical climate risk presents a critical question for global sustainability governance: does exposure to climate hazards strengthen or weaken a country's environmental, social and governance (ESG) performance? This study investigates the relationship between climate vulnerability and country‐level ESG performance across
Alanoud Al‐Maadid, Mohamed Sami Ben Ali, Brahim Bergougui   +2 more
wiley   +1 more source

Sprayable Polyolefin Sorbents Enabled by Bio‐Solvents for Large‐Scale Oil and Chemical Spill Recovery

ENERGY &ENVIRONMENTAL MATERIALS, EarlyView.
A sprayable POE‐based sorbent formulated with a green solvent blend of α‐pinene, D‐limonene, and p‐cymene enables rapid in situ film formation via solvent evaporation, allowing efficient pollutant capture. The system exhibits high oil uptake (37.3 g g−1) and effectively removes up to 60 mL of VLSFO under simulated marine spill conditions.
Youngmin Choi, Changwoo Nam
wiley   +1 more source

The Birnessite Structure: A Versatile Electrode Platform for Advanced Electrochemical Energy Storage

ENERGY &ENVIRONMENTAL MATERIALS, EarlyView.
Birnessite attracts considerable attention for electrochemical energy storage owing to its layered structure, natural abundance, and environmentally friendliness. This review systematically summarizes its synthesis mechanisms, modification strategies, and applications across diverse energy storage systems.
Tong Wang, Heru Huang, Hao Li, Yuhang Zhuang, Mingzhe Chen, Qi Fan, Chenyin Li, Xiaohui Zhu, Hui Xia   +8 more
wiley   +1 more source

Recent Progress of Metal Halide Perovskite‐Based S‐Scheme Heterojunction for Solar Energy Conversion

ENERGY &ENVIRONMENTAL MATERIALS, EarlyView.
Recent advances in metal halide perovskite‐based S‐scheme photocatalytic heterojunctions are systematically reviewed in this work. Synthetic protocols, state‐of‐the‐art characterizations for tracking interfacial charge transfer, and their diverse photocatalytic applications are thoroughly explored.
Xinhe Wu, Shujie Yin, Jiachao Xu, Lihong Tan, Guohong Wang   +4 more
wiley   +1 more source

Metabolic abnormalities and reprogramming in cats with naturally occurring hypertrophic cardiomyopathy

ESC Heart Failure, Volume 12, Issue 2, Page 1256-1270, April 2025.
Abstract Background and aims The heart is a metabolic organ rich in mitochondria. The failing heart reprograms to utilize different energy substrates, which increase its oxygen consumption. These adaptive changes contribute to increased oxidative stress.
Qinghong Li, Max Homilius, Erin Achilles, Laura K. Massey, Victoria Convey, Åsa Ohlsson, Ingrid Ljungvall, Jens Häggström, Brittany Vester Boler, Pascal Steiner, Sharlene Day, Calum A. MacRae, Mark A. Oyama   +12 more
wiley   +1 more source

Cytotoxicity of 19 Pesticides in Rainbow Trout Gill, Liver, and Intestinal Cell Lines

Environmental Toxicology and Chemistry, EarlyView.
Abstract The rainbow trout gill cell line (RTgill‐W1), via test guideline 249 of the Organisation for Economic Co‐operation and Development, has been established as a promising New Approach Methodology, although to advance confidence in the method more case studies are needed that: 1) expand our understanding of applicability domains (chemicals with ...
Sophie Emberley‐Korkmaz, Krittika Mittal, Na'im Temlock, Jessica Head, Niladri Basu   +4 more
wiley   +1 more source