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11.
药物相互作用改变了剂量效应关系,可能会降低疗效或增加毒性,是临床应用中合并用药治疗时重要的考虑因素。预测具有临床意义的药物相互作用是药物研发过程中获益风险评估的重要环节。本文概述了药物研发过程中药物相互作用研究的目的和意义,体内和体外研究的主要内容;梳理分析了2020年国家药品监督管理局(National Medical Products Administration, NMPA)和美国食品药品监督管理局(Food and Drug Administration, FDA)批准上市的新药药物相互作用研究情况,旨在为我国药物研发过程中药物相互作用研究及其监管审评提供参考。 相似文献
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Yujie Chen Yiping Song Zhen Zhang Yali Chen Qiliang Deng Shuo Wang 《Advanced functional materials》2021,31(41):2104885
Various products, including foods and pharmaceuticals, are sensitive to temperature fluctuations. Thus, temperature monitoring during production, transportation, and storage is critical. Facile indicators are required to monitor temperature conditions via color changes in real time. This study aimed to prepare and apply thiol-functionalized covalent organic frameworks (COFs) as a novel indicator for monitoring thermal history and temperature abuse. The COFs underwent obvious color changes from bright yellow to purple after exposure to different temperatures for varying durations. The reaction kinetics are analyzed under isothermal conditions, which reveal that the order of reaction rates is k−20°C < k4°C < k20°C < k35°C < k55°C. The activation energy (Ea) of the COFs is calculated using the Arrhenius equation as 50.71 kJ moL−1. The COFs are capable of sensitive color changes and offer a broad temperature tracking range, thereby demonstrating their application potential for the monitoring of temperature and time exposure history during production, transportation, and storage. This excellent performance thermal history indicator also shows promise for expanding the application field of COFs. 相似文献
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综述了铁素体与铁素体异种金属焊缝(dissimilar metal welds,DMWs)接头界面组织及其影响。结果表明,在焊后热处理或运行温度下的铁素体钢DMWs接头的不均匀界面组织中,通常会形成脱碳层和增碳层。在铁素体钢DMWs焊接接头界面组织影响因素中,焊缝金属的化学成分有重要影响;焊后热处理规范(温度和时间)、工作温度下运行时间的影响较为突出;焊接工艺参数的影响亦不可忽略。异种钢接头界面处近缝区裂纹的产生,以及接头的蠕变强度随Larson Miller 参数增大而下降等不利影响,均为异种钢界面碳迁移行为所导致。焊缝成分控制法是接头界面组织控制或改善的必要条件,而脱碳层部位转移法能有效防止裂纹发生,亦是接头安全运行的重要工艺措施之一。 相似文献
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Chuncheng Wei Zhen Liu Yun Wu Yeqing Liu Heng Zhang Peng Wang Qiyan Sun Lijuan Zhou 《Ceramics International》2021,47(13):18693-18698
Laminated Si3N4/SiCw ceramics were successfully prepared by tape casting and hot-pressing. Its mechanical properties were measured and the impact resistance was discussed. The toughness of the laminated Si3N4/SiCw ceramics was 13.5 MPa m1/2, which was almost 1.6 times that of Si3N4/SiCw composite ceramics, namely 8.5 MPa m1/2. Moreover, the indentation strength of laminated Si3N4/SiCw ceramics was not sensitive to increasing indentation loads and exhibited a rising R-curve behaviour, indicating that the laminated Si3N4/SiCw ceramics had excellent impact resistance. The improved toughness and impact resistance of laminated Si3N4/SiCw ceramics was attributed to the residual stress caused by a thermal expansion coefficient mismatch between the different layers, resulting in crack deflection and bridging of SiC whiskers in the interface layer, thus consuming a large amount of fracture work. 相似文献
18.
Katja F. Hellendahl Felix Kaspar Dr. Xinrui Zhou Zhaoyi Yang Prof. Dr. Zhen Huang Prof. Dr. Peter Neubauer Dr. Anke Kurreck 《Chembiochem : a European journal of chemical biology》2021,22(11):2002-2009
Selenium-modified nucleosides are powerful tools to study the structure and function of nucleic acids and their protein interactions. The widespread application of 2-selenopyrimidine nucleosides is currently limited by low yields in established synthetic routes. Herein, we describe the optimization of the synthesis of 2-Se-uridine and 2-Se-thymidine derivatives by thermostable nucleoside phosphorylases in transglycosylation reactions using natural uridine or thymidine as sugar donors. Reactions were performed at 60 or 80 °C and at pH 9 under hypoxic conditions to improve the solubility and stability of the 2-Se-nucleobases in aqueous media. To optimize the conversion, the reaction equilibria in analytical transglycosylation reactions were studied. The equilibrium constants of phosphorolysis of the 2-Se-pyrimidines were between 5 and 10, and therefore differ by an order of magnitude from the equilibrium constants of any other known case. Hence, the thermodynamic properties of the target nucleosides are inherently unfavorable, and this complicates their synthesis significantly. A tenfold excess of sugar donor was needed to achieve 40−48 % conversion to the target nucleoside. Scale-up of the optimized conditions provided four Se-containing nucleosides in 6–40 % isolated yield, which compares favorably to established chemical routes. 相似文献
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构建工程咨询机构BIM技术应用能力评价的指标体系,提出改进的熵权TOPSIS评价模型,以4个典型的工程咨询单位为例,进行BIM技术运用能力评价。研究表明,BIM行业的整体水平已经有了明显的提升,但是区域间的发展还存在一定差距。 相似文献