Results 1 to 10 of about 1,554,548 (330)

KRAS(G12C)–AMG 510 interaction dynamics revealed by all-atom molecular dynamics simulations

Scientific Reports, 2020
The first KRAS(G12C) targeting inhibitor in clinical development, AMG 510, has shown promising antitumor activity in clinical trials. On the molecular level, however, the interaction dynamics of this covalently bound drug–protein complex has been ...
Tatu Pantsar
doaj   +2 more sources

Influence of Pre-Hydrolysis on the Chemical Composition of Prunus avium Cherry Seeds

Agronomy, 2022
During the industrial processing of sweet cherry fruits, the seeds are considered agricultural waste and must be disposed of, typically through burning. In this context, it is intended to contribute to the scientific development of the ecovalorization of
Luísa Cruz-Lopes, Yuliya Dulyanska, Idalina Domingos, José Ferreira, Anabela Fragata, Raquel Guiné, Bruno Esteves   +6 more
doaj   +1 more source

Review of approvals and recalls of US specific medical devices in general and plastic surgery

Surgery in Practice and Science, 2023
Background: Medical devices in the United States can be FDA approved either by the premarket notification (510(k)) or premarket approval process (PMA). Applications for PMA are more intensive than 510(k).
Aashka Shah, Michelle M. Olson, Joseph M. Maurice   +2 more
doaj   +1 more source

Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance.

Journal of the American Medical Association (JAMA), 2023
Importance Most regulated medical devices enter the US market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are "substantially equivalent" to 1 or more "predicate" devices (legally marketed medical
Alexander O Everhart, S. Sen, A. Stern, Yi Zhu, P. Karaca-Mandic   +4 more
semanticscholar   +1 more source

Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.

Journal of the American Medical Association (JAMA), 2023
Importance In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations.
Kushal T. Kadakia, S. Dhruva, C. Caraballo, J. Ross, H. Krumholz   +4 more
semanticscholar   +1 more source

Clinical characteristics, activity levels and mental health problems in children with long coronavirus disease: a survey of 510 children

Future Microbiology, 2022
Background: Whether long coronavirus disease pertains to children as well is not yet clear. Methods: The authors performed a survey in children suffering from persistent symptoms since initial infection.
D. Buonsenso, Ferran Espuny Pujol, D. Munblit, D. Pata, Sammie McFarland, Frances K Simpson   +5 more
semanticscholar   +1 more source

High Levels of Physical Activity Reduce the Esthetic Durability of Botulinum Toxin Type A: A Controlled Single-Blind Clinical Trial

Toxins, 2023
The present study aimed to evaluate the influence of physical activity on the durability of the esthetic effect of botulinum toxin type A (BoNT-A). Sixty female patients were allocated to three groups (n = 20) according to their physical activity level ...
Omar Neves Morhy, Andréa Lisbôa Sisnando, Mariana Barbosa Câmara-Souza, Ana Claudia Carbone, Giancarlo De la Torre Canales   +4 more
doaj   +1 more source

Study on Support Mechanisms for Renewable Energy Sources in Poland

Energies, 2022
Poland, as a member of the European Union (EU), has to fulfill the obligations resulting from its membership in it. It is necessary to comply with numerous directives and other legal provisions adopted by the European Commission in the field of the ...
Agnieszka Mazurek-Czarnecka, Ksymena Rosiek, Marcin Salamaga, Krzysztof Wąsowicz, Renata Żaba-Nieroda   +4 more
doaj   +1 more source

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017

JAMA Network Open, 2021
Key Points Question What is the risk of recall and high-risk recall for devices undergoing US Food and Drug Administration (FDA) 510(k) clearance compared with premarket approval (PMA)? Findings In this cohort study using the FDA’s 510(k) and PMA medical
Jonathan R Dubin, S. Simon, Kirsten Norrell, Jacob Perera, Jacob Gowen, A. Cil   +5 more
semanticscholar   +1 more source

Understanding the influence of AMG 510 on the structure of KRASG12C empowered by molecular dynamics simulation

Computational and Structural Biotechnology Journal, 2022
The KRASG12C mutant is often associated with human cancers, and AMG 510 as a promising covalent inhibitor of KRASG12C has achieved surprising efficacy in clinical trials.
Yu Li, Lei Han, Ziding Zhang
doaj   +1 more source