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1.
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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Giorgio Valabrega Giulia Scotto Valentina Tuninetti Arianna Pani Francesco Scaglione 《International journal of molecular sciences》2021,22(8)
Poly(ADP-ribose) polymerases (PARP) are proteins responsible for DNA damage detection and signal transduction. PARP inhibitors (PARPi) are able to interact with the binding site for PARP cofactor (NAD+) and trapping PARP on the DNA. In this way, they inhibit single-strand DNA damage repair. These drugs have been approved in recent years for the treatment of ovarian cancer. Although they share some similarities, from the point of view of the chemical structure and pharmacodynamic, pharmacokinetic properties, these drugs also have some substantial differences. These differences may underlie the different safety profiles and activity of PARPi. 相似文献
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Karolina Storesund Francine Amon Anne Steen‐Hansen Shayesteh Haghighatpanah Ida Larsson 《火与材料》2021,45(1):181-190
The aim of this exploratory study has been to investigate the fire properties and environmental aspects of different upholstery material combinations, mainly for domestic applications. An analysis of the sustainability and circularity of selected textiles, along with lifecycle assessment, is used to qualitatively evaluate materials from an environmental perspective. The cone calorimeter was the primary tool used to screen 20 different material combinations from a fire performance perspective. It was found that textile covers of conventional fibres such as wool, cotton and polyester, can be improved by blending them with fire resistant speciality fibres. A new three‐dimensional web structure has been examined as an alternative padding material, showing preliminary promising fire properties with regard to ignition time, heat release rates and smoke production. 相似文献
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分析近年来RTO装置发生的安全事故,找出了该类环保装置存在的安全风险,并在储罐与污水池废气分类处理、在线废气浓度检测仪与废气切断阀的位置设置、新风稀释及风机控制、阻火器与爆破片、操作压力、储罐呼吸阀后采用非接触废气罩收集、风机材质等方面提出了建议。 相似文献
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In this study, sea bream, sea bass, anchovy and trout were captured and recorded using a digital camera during refrigerated storage for 7 days. In addition, their total viable counts (TVC) were determined on a daily basis. Based on the TVC, each fish was classified as ‘fresh’ when it was <5 log cfu per g, and as ‘not fresh’ when it was >7 log cfu per g. They were uploaded on a web-based machine learning software called Teachable Machine (TM), which was trained about the pupils and heads of the fish. In addition, images of each species from different angles were uploaded to the software in order to ensure the recognition of fish species by TM. The data of the study indicated that the TM was able to distinguish fish species with high accuracy rates and achieved over 86% success in estimating the freshness of the fish species tested. 相似文献
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《International Journal of Hydrogen Energy》2022,47(6):4222-4235
Quantitative Risk Assessment (QRA) supports the development of risk-informed safety codes and standards which are employed to enable the safe deployment of hydrogen technologies essential to decarbonize the transportation sector. System reliability data is a necessary input for rigorous QRA. The lack of reliability data for bulk liquid hydrogen (LH2) storage systems located on site at fueling stations limits the use of QRAs. In turn, this hinders the ability to develop the necessary safety codes and standards that enable worldwide deployment of these stations. Through a QRA-based analysis of a LH2 storage system, this work focuses on identifying relevant scenario and probability data currently available and ascertaining future data collection requirements regarding risks specific to liquid hydrogen releases. The work developed consists of the analysis of a general bulk LH2 storage system design located at a hydrogen fueling station. Failure Mode and Effect Analysis (FMEA) and traditional QRA modeling tools such as Event Sequence Diagrams (ESD) and Fault Tree Analysis (FTA) are employed to identify, rank, and model risk scenarios related to the release of LH2. Based on this analysis, scenario and reliability data needs to add LH2-related components to QRA are identified with the purpose of improving the future safety and risk assessment of these systems. 相似文献
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Ceramics are considered intrinsically brittle at room temperature, which is mainly attributed to the limited availability of crystallographic slips and pre-existing geometrical flaws. Moreover, the lack of flexibility has severely hindered many high-end applications of ceramic materials. Here, we produce ceramic sponges that are simultaneously ultra-light, elasto-flexible, thermally insulating, and can fully recover from large deformation with a near-zero Poisson's ratio. These spongy materials also possess superb fatigue resistance without the accumulation of damage or structural collapse for 10,000 large-scale compressive or buckling cycles. We demonstrate the exceptional flexibility is enabled by the elastic distortion of nanograin–glassy dual phase and the fiber bulking in open-cell three-dimensional structure. Moreover, these spongy materials possess superior temperature-invariant superelasticity from deep cryogenic temperatures (−196 °C) to high temperature (1500 °C). Our study not only developed mechanically reliable lightweight ceramics for numerous extreme applications, but also provided new theoretical insights into the origin of flexibility in polycrystalline ceramics. 相似文献