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Comparison of safety profiles for dapagliflozin based on EMA and FDA safety issues: Challenges and future of post-marketing surveillance in Korea.
PLoS One
November 2024
Department of Health Convergence, College of Science and Industry Convergence, Ewha Womans University, Seoul, Korea.
Article Synopsis
- Europe, the U.S., and Korea each have systems to track rare adverse events from drugs after they are marketed, with Korea focusing on a re-examination system and risk management plan to monitor safety.
- This study compares post-marketing safety issues related to the drug dapagliflozin as identified by the European Medicines Agency (EMA), the U.S. FDA, and the Korean Ministry of Food and Drug Safety.
- There is a 71% agreement between safety issues found by the EMA/FDA and those noted in Korea, but Korea's system struggles with long-term outcome tracking and needs better regulations and guidelines for ongoing safety assessments.
Putative Identification of 47 Compounds from Jieyu Anshen Granule and Proposal of Pharmacopeia Quality-Assessment Strategy Using TCM-Specific Library with UHPLC-Q-Exactive-Orbitrap-MS.
ChemistryOpen
January 2025
Department of Chemistry, University of Malakand, Chakdara, 18800, Dir Lower, Khyber Pakhtunkhwa, Pakistan.
Jieyu Anshen Granule is a traditional Chinese medicine prescription used for depression and primarily comprises five herbal medicines: Zhizi, Chaihu, Zhigancao, Danggui, and Yuanzhi. This study established a traditional Chinese herbal medicine-specific library using emerging ultra-high-performance liquid chromatography-quadrupole-orbitrap-tandem mass spectrometry analysis. Through library comparison, the study has fulfilled isomers distinction.
View Article and Find Full Text PDFTowards the synthesis of a 2-deoxy-2-fluoro-d-mannose building block and characterisation of an unusual 2-S-phenyl anomeric pyridinium triflate salt via 1 → 2 S-migration.
Carbohydr Res
November 2024
Centre for Glycoscience and Lennard-Jones Laboratory, School of Chemical and Physical Sciences, Keele University, Keele, Staffordshire, ST5 5BG, UK. Electronic address:
Regio- and stereo-selective synthetic routes to 2-deoxy-2-fluoro-d-mannose building blocks are often experimentally challenging when using Selectfluor with the corresponding glycal. We targeted a late-stage method to introduce fluorine in a stereospecific manner using inversion via a triflate. Accordingly, synthesis of a conventionally protected 2-deoxy-2-fluoro-d-mannose β-thioglycoside donor, directly applicable to oligosaccharide synthesis, was attempted using C2-triflate inversion of the corresponding d-glucoside with TBAF.
View Article and Find Full Text PDFSurufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial.
Signal Transduct Target Ther
September 2024
Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
Article Synopsis
- A clinical trial was conducted to evaluate a novel four-drug regimen (surufatinib, toripalimab, etoposide, and cisplatin) for first-line treatment of advanced small cell lung cancer (SCLC), registered as NCT04996771.
- The primary measure of success was progression-free survival (PFS), while secondary measures included overall survival (OS) and response rates; results showed a 97.1% objective response rate and a median OS of 21.1 months.
- Although the treatment had a 63.2% rate of grade ≥3 adverse events, the adverse effects were manageable, suggesting that this regimen has promising efficacy with tolerable safety levels.
Discovery, characterization, and comparative analysis of new UGT72 and UGT84 family glycosyltransferases.
Commun Chem
June 2024
Institute of Biotechnology and Biochemical Engineering, Graz University of Technology, NAWI Graz, Petersgasse 12/1, 8010, Graz, Austria.
Glycosylated derivatives of natural product polyphenols display a spectrum of biological activities, rendering them critical for both nutritional and pharmacological applications. Their enzymatic synthesis by glycosyltransferases is frequently constrained by the limited repertoire of characterized enzyme-catalyzed transformations. Here, we explore the glycosylation capabilities and substrate preferences of newly identified plant uridine diphosphate (UDP)-dependent glycosyltransferases (UGTs) within the UGT72 and UGT84 families, with particular focus on natural polyphenol glycosylation from UDP-glucose.
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