Results 161 to 170 of about 1,823,738 (182)

Analysis of Complications in Sacroiliac Joint Fusions Using FDA 510(k) Cleared Devices

Clinical Spine Surgery, 2021
Study Design: This was a level III—retrospective cohort study. Objective: The objective of this study was to present an unbiased report of the current rate of severe complications for Federal Drug Administration (FDA) 510(k) cleared sacroiliac joint (SIJ)
Michael D. Rahl, Joseph K. Weistroffer, B. E. Dall   +2 more
semanticscholar   +1 more source

Phase 1 study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of AMG 510, a novel small molecule KRASG12C inhibitor, in advanced solid tumors.

Journal of Clinical Oncology, 2019
3003 Background: The KRASG12C mutation is found in approximately 13% of lung adenocarcinomas and 1–3% of other solid tumors, but there is no approved therapy that targets this mutation. AMG 510 is a novel small molecule that specifically and irreversibly
M. Fakih, B. O'Neil, T. Price, G. Falchook, J. Desai, J. Kuo, R. Govindan, E. Rasmussen, P. K. Morrow, J. Ngang, H. Henary, D. Hong   +11 more
semanticscholar   +1 more source

CircRNA SCARB1 promotes renal cell carcinoma progression via miR-510-5p/SDC3 axis.

Current Cancer Drug Targets, 2020
BACKGROUND Emerging studies have indicated that circular RNAs (circRNAs) play important roles in the development of many tumors. CircRNA-scavenger receptor class B member 1 (Circ-SCARB1) was consistently reported as an elevated circRNA in RCC tissues ...
Jijian Sun, Shijie Pan, Hong Cui, Hao Li
semanticscholar   +1 more source

Insights into the Hydrogen Coverage Effect and the Mechanism of Fischer–Tropsch to Olefins Process on Fe5C2 (510)

, 2020
Direct production of light olefins from synthesis gas through the Fischer–Tropsch to Olefins (FTO) process over iron carbide catalysts is promising.
Minhua Zhang, Jie Ren, Yingzhe Yu
semanticscholar   +1 more source

Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process

Annals of Internal Medicine
Nearly all medical devices reviewed by the U.S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. Established in 1976, this review pathway bases authorizations on the comparability of new devices to previously authorized
Kushal T Kadakia, Vinay K. Rathi, Sacket S. Dhruva, Joseph S. Ross, H. Krumholz   +4 more
semanticscholar   +1 more source

CodeBreak 100: Activity of AMG 510, a novel small molecule inhibitor of KRASG12C, in patients with advanced colorectal cancer.

, 2020
4018Background: Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation is associated with poor prognosis in colorectal cancer (CRC).
M. Fakih, J. Desai, Y. Kuboki, J. Strickler, T. Price, G. Durm, G. Falchook, C. Denlinger, J. Krauss, G. Shapiro, Tae Won Kim, Keunchil Park, A. Coveler, P. Munster, Bob T. Li, June Kim, H. Henary, G. Ngarmchamnanrith, D. Hong   +18 more
semanticscholar   +1 more source

Validated HPLC-MS/MS method for quantitation of AMG 510, a KRAS G12C inhibitor in a small volume of mouse plasma and its application to a pharmacokinetic study in mice.

Biomedical chromotography, 2020
AMG 510 is the first-in-class KRASG12C inhibitor, currently entering into Phase-2 clinical trials as an orphan drug to treat non-small cell lung cancer patients.
N. Madhyastha, Swapan Kumar Samantha, Sreekanth Dittakavi, Meenu Markose, S. Mallurwar, M. Zainuddin, R. Mullangi   +6 more
semanticscholar   +1 more source

microRNA‐510‐5p promotes thyroid cancer cell proliferation, migration, and invasion through suppressing SNHG15

Journal of Cellular Biochemistry, 2019
SNHG15 has been suggested to be correlated with clinical progression and prognosis, and function as tumor suppressive long noncoding RNA in thyroid cancer at our previous study.
Yongcun Liu, Junli Li, M. Li, Feng Li, Y. Shao, Liping Wu   +5 more
semanticscholar   +1 more source

Modernizing the FDA's 510(k) Pathway.

New England Journal of Medicine, 2019
Modernizing the FDA’s 510(k) Pathway More than 90% of FDA-reviewed devices enter the market by means of the 510(k) pathway. In September 2019, the FDA finalized reforms to the pathway.
V. Rathi, J. Ross
semanticscholar   +1 more source

Abstract 4484: Discovery and in vitro characterization of AMG 510–a potent and selective covalent small-molecule inhibitor of KRASG12C

Experimental and Molecular Therapeutics, 2019
Activating mutations in RAS represent the most common oncogenic driver mutation in cancer. The single amino acid substitution of cysteine for glycine at position 12 (KRASG12C) is frequently found in solid malignancies, particularly in lung adenocarcinoma
A. Y. Saiki, Kevin Gaida, K. Rex, Pragathi Achanta, T. S. Miguel, Neelima Koppada, Dhanashri Bagal, B. Lanman, Robert S. Foti, J. McCarter, Laurie P. Volak, J. Canon, V. Cee, J. Lipford   +13 more
semanticscholar   +1 more source