Control strategy

  • 文章类型: Journal Article
    这项工作旨在提出一种设计质量(QbD)分步方法,以配制抗溃疡和胃保护性口服混悬剂。
    使用硫糖铝作为药物模型。质量目标产品概况是在配制前早期建立的。粘度,可重悬,pH值,通过筛选基于不同原型组成的几个悬浮平台来评估密度。通过热分析和红外光谱进行活性药物成分与赋形剂之间的相容性研究。采用Ishikawa鱼骨图和失效模式和效应分析来确定关键材料属性(CMA),关键工艺参数(CPPs),和关键质量属性(CQA)。在制造后的正常条件下和在超加速应力条件下一个月,通过22个全因子实验设计进一步评估了CMA和CPPs对已确定的CQA的影响。
    铅原型没有显示物理化学不相容性。风险评估工具表明,润湿剂的浓度和增稠剂的总浓度代表了粘度方面制剂质量分布的关键因素。包含1.125w/v%总浓度的Natrosol250HX和AvicelRC591的优化制剂根据所建立的曲线表现出增强的性能。
    分析和物理化学测试显示了最终制剂与质量概况的稳健性和合规性。提出的基于QBD的分步方法,实验设计,我们研究中提出的质量风险管理对参与口服混悬剂开发的当地行业和配方科学家具有实际意义。
    UNASSIGNED: This work aims to present a Quality-by-Design (QbD) step-by-step methodology to formulate anti-ulcer and gastro-protective oral suspensions.
    UNASSIGNED: Sucralfate was used as a drug model. The Quality Target Product Profile was established early during preformulation. Viscosity, resuspendability, pH, and density were assessed through the screening of several suspension platforms based on different prototype compositions. A compatibility study between the active pharmaceutical ingredient and the excipients was performed by thermal analysis and infrared spectroscopy. An Ishikawa fishbone diagram and Failure Mode and Effect Analysis were employed to identify the Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs). CMAs\' and CPPs\' impact on identified CQAs was further assessed through a 22 full factorial experimental design at normal conditions after manufacture and one month at super-accelerated stress conditions. Results: The lead prototype exhibited no physicochemical incompatibilities. The risk assessment tools revealed that the concentration of the wetting agent and the total concentration of thickening agents represented critical factors for the quality profile of the preparation in terms of viscosity. The optimized formulation comprising 1.125 w/v% total concentration of Natrosol 250 HX and Avicel RC 591 exhibited an enhanced performance according to the established profile.
    UNASSIGNED: The analytical and physicochemical tests showed the robustness and compliance of the final preparation with the quality profile. The proposed step-by-step methodology based on QbD, Design of Experiments, and Quality Risk Management presented in our research holds practical implications for local industries and formulation scientists involved in the development of oral suspensions.
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  • 文章类型: Journal Article
    由于食品安全对人类健康和整体福祉的直接影响,食品安全是全球关注的焦点。在食品加工环境中,食源性病原体的生物膜形成带来了一个重大问题,因为它导致持续和高水平的食品污染,从而损害食品的质量和安全性。因此,有效去除食品加工环境中的生物被膜,确保食品安全势在必行。不幸的是,传统的清洁方法不足以充分去除生物膜,它们甚至可能进一步污染设备和食物。有必要开发替代方法来应对食品工业中的这一挑战。解决生物膜相关问题的一个有前途的策略是生物膜分散,这代表了生物膜开发的最后一步。这里,我们讨论了食源性病原体的生物膜分散机制,并阐明了生物膜分散如何用于控制和减轻生物膜相关问题。通过揭示这些方面,我们的目标是提供有价值的见解和解决方案,以有效解决食品工业中的生物膜污染问题,从而提高食品安全和确保消费者的福祉。
    Food safety is a critical global concern due to its direct impact on human health and overall well-being. In the food processing environment, biofilm formation by foodborne pathogens poses a significant problem as it leads to persistent and high levels of food contamination, thereby compromising the quality and safety of food. Therefore, it is imperative to effectively remove biofilms from the food processing environment to ensure food safety. Unfortunately, conventional cleaning methods fall short of adequately removing biofilms, and they may even contribute to further contamination of both equipment and food. It is necessary to develop alternative approaches that can address this challenge in food industry. One promising strategy in tackling biofilm-related issues is biofilm dispersion, which represents the final step in biofilm development. Here, we discuss the biofilm dispersion mechanism of foodborne pathogens and elucidate how biofilm dispersion can be employed to control and mitigate biofilm-related problems. By shedding light on these aspects, we aim to provide valuable insights and solutions for effectively addressing biofilm contamination issues in food industry, thus enhancing food safety and ensuring the well-being of consumers.
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  • 文章类型: Journal Article
    生物膜,附着在表面的复杂的微生物群落,尤其是医疗设备,形成胞外多糖基质,使细菌能够抵抗环境压力和常规抗菌剂,导致多重耐药性的出现。与医疗器械相关的生物膜相关感染是重大的公共卫生威胁,降低设备性能。因此,开发监督和管理生物膜生长的有效方法势在必行。这篇深入的综述提供了监测和控制细菌生物膜的策略的系统概述。我们首先概述了生物膜的创建过程及其调控机制。然后讨论进展到用于生物膜检测和不同治疗策略的生物传感器的进步。最后,这项审查审查了与该领域相关的障碍和新观点,以促进创新的监测和控制解决方案的发展。这些进步对于对抗多药耐药细菌的传播和减轻与医疗器械上生物膜形成的感染相关的公共卫生风险至关重要。
    Biofilms, intricate microbial communities that attach to surfaces, especially medical devices, form an exopolysaccharide matrix, which enables bacteria to resist environmental pressures and conventional antimicrobial agents, leading to the emergence of multi-drug resistance. Biofilm-related infections associated with medical devices are a significant public health threat, compromising device performance. Therefore, developing effective methods for supervising and managing biofilm growth is imperative. This in-depth review presents a systematic overview of strategies for monitoring and controlling bacterial biofilms. We first outline the biofilm creation process and its regulatory mechanisms. The discussion then progresses to advancements in biosensors for biofilm detection and diverse treatment strategies. Lastly, this review examines the obstacles and new perspectives associated with this domain to facilitate the advancement of innovative monitoring and control solutions. These advancements are vital in combating the spread of multi drug-resistant bacteria and mitigating public health risks associated with infections from biofilm formation on medical instruments.
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  • 文章类型: Journal Article
    布鲁氏菌病,由布氏杆菌引起的。,是一种正在重新出现的一种健康疾病,在中国奶牛和人类中患病率和发病率都有所增加,严重影响动物生产力和公众健康。在奶牛中,流产芽孢杆菌是主要病原体,尽管偶尔会发生其他布鲁氏菌感染。然而,由于不同地区的异质性,在整个中国,人们对流产芽孢杆菌在奶牛和人类中的流行病学和相对重要性仍然缺乏充分的了解,质量,和研究方法。本范围综述旨在描述奶牛和人类流产芽孢杆菌感染的变化状况,调查循环布鲁氏菌的种类和生物变量,并通过从四个数据库中检索可公开访问的文献来确定驱动疾病传播的因素。通过预先指定的纳入标准后,最终合成中包括60篇原始文章。尽管与其他流行国家(例如伊朗和印度)相比,奶牛中布鲁氏菌病的动物水平和农场水平的流行率较低,据报道,在过去十年里,这一数字有所增加。布鲁氏菌病在人类中的发病率显示出季节性增加。玫瑰红试验和血清凝集试验,在系列中解释,是诊断布鲁氏菌属最常用的血清学测试。在奶牛和人类中。B.abortusbiovar3是奶牛的主要物种(81.9%)和biovar(70.3%),和B.melitensisbiovar3被确定为人类布鲁氏菌病病例中最常见的检测菌株。这些菌株主要集中在内蒙古和陕西(75.7%),限制了结果在其他省份的普适性。活牛的运动或贸易被确定为推动布鲁氏菌病传播的关键因素,但其在中国乳制品行业的传播模式仍然未知。这些知识差距需要一种更有效的“一个健康”方法来弥合。协调和基于证据的研究计划对于告知在中国背景下既可行又经济的区域或国家控制策略至关重要。
    Brucellosis, caused by Brucella spp., is a re-emerging One Health disease with increased prevalence and incidence in Chinese dairy cattle and humans, severely affecting animal productivity and public health. In dairy cattle, B. abortus is the primary causative agent although infections with other Brucella species occur occasionally. However, the epidemiological and comparative importance of B. abortus in dairy cattle and humans remains inadequately understood throughout China due to the heterogeneity in locations, quality, and study methods. This scoping review aims to describe the changing status of B. abortus infection in dairy cattle and humans, investigate the circulating Brucella species and biovars, and identify factors driving the disease transmission by retrieving publicly accessible literature from four databases. After passing the prespecified inclusion criteria, 60 original articles were included in the final synthesis. Although the reported animal-level and farm-level prevalence of brucellosis in dairy cattle was lower compared to other endemic countries (e.g. Iran and India), it has been reported to increase over the last decade. The incidence of brucellosis in humans displayed seasonal increases. The Rose Bengal Test and Serum Agglutination Test, interpreted in series, were the most used serological test to diagnose Brucella spp. in dairy cattle and humans. B. abortus biovar 3 was the predominant species (81.9%) and biovar (70.3%) in dairy cattle, and B. melitensis biovar 3 was identified as the most commonly detected strain in human brucellosis cases. These strains were mainly clustered in Inner Mongolia and Shannxi Province (75.7%), limiting the generalizability of the results to other provinces. Live cattle movement or trade was identified as the key factor driving brucellosis transmission, but its transmission pattern remains unknown within the Chinese dairy sector. These knowledge gaps require a more effective One Health approach to be bridged. A coordinated and evidence-based research program is essential to inform regional or national control strategies that are both feasible and economical in the Chinese context.
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  • 文章类型: Journal Article
    减少能源利用中的空气污染物和二氧化碳排放对于实现中国清洁空气和碳中和的双重目标至关重要。因此,迫切需要一个优化的健康导向战略。在这里,通过将二氧化碳和空气污染物排放清单与PM2.5相关死亡率的响应面模型相结合,我们阐明了保护人类健康的有效性和减少燃料相关排放的CO-CO2利益,并为长江三角洲(YRD)制定了以健康为导向的战略。结果表明,石油消耗是导致与燃料相关的PM2.5污染和YRD过早死亡的主要原因。重要的是,减少运输中的燃料消耗是减轻与燃料相关的PM2.5对健康影响的最有效措施,在区域范围内对二氧化碳减排也具有最大的效益。减少燃料消耗将大大改善健康,特别是在东部YRD,非道路车辆减排对健康保护特别有影响,而公路车辆在减少二氧化碳方面的潜力最大。情景分析证实了减轻运输部门石油消费对解决PM2.5污染和气候变化的重要性。
    Reducing air pollutants and CO2 emissions from energy utilization is crucial for achieving the dual objectives of clean air and carbon neutrality in China. Thus, an optimized health-oriented strategy is urgently needed. Herein, by coupling a CO2 and air pollutants emission inventory with response surface models for PM2.5-associated mortality, we shed light on the effectiveness of protecting human health and co-CO2 benefit from reducing fuel-related emissions and generate a health-oriented strategy for the Yangtze River Delta (YRD). Results reveal that oil consumption is the primary contributor to fuel-related PM2.5 pollution and premature deaths in the YRD. Significantly, curtailing fuel consumption in transportation is the most effective measure to alleviate the fuel-related PM2.5 health impact, which also has the greatest cobenefits for CO2 emission reduction on a regional scale. Reducing fuel consumption will achieve substantial health improvements especially in eastern YRD, with nonroad vehicle emission reductions being particularly impactful for health protection, while on-road vehicles present the greatest potential for CO2 reductions. Scenario analysis confirms the importance of mitigating oil consumption in the transportation sector in addressing PM2.5 pollution and climate change.
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  • 文章类型: Journal Article
    可穿戴式躯干外骨骼在医疗保健和工业等领域具有巨大潜力。先前的研究表明,意图识别控制在用户日常使用外骨骼中起着至关重要的作用。
    这篇评论旨在讨论过去十年来在不同控制目标下用于智能躯干外骨骼的意图识别控制方案的特征。
    考虑到主动躯干外骨骼的发展相对较晚,我们选择了过去十年(2013年至2023年)在WebofScience上发表的论文,PubMed,和IEEEXplore数据库。总的来说,根据四个控制目标选择并检查了50篇文章。
    一般来说,我们发现,研究人员专注于为辅助和运动增强而设计的躯干外骨骼设备,更依赖于身体运动信号作为意图识别的来源。
    基于这些结果,我们确定并讨论了几个有前途的研究方向,可能有助于获得广泛接受的控制方法,从而推进躯干外骨骼技术的进一步发展。
    UNASSIGNED: Wearable trunk exoskeletons hold immense potential in fields such as healthcare and industry. Previous research has indicated that intention recognition control plays a crucial role in users\' daily use of exoskeletons.
    UNASSIGNED: This review aims to discuss the characteristics of intention recognition control schemes for intelligent trunk exoskeletons under different control objectives over the past decade.
    UNASSIGNED: Considering the relatively late development of active trunk exoskeletons, we selected papers published in the last decade (2013 to 2023) from the Web of Science, PubMed, and IEEE Xplore databases. In total, 50 articles were selected and examined based on four control objectives.
    UNASSIGNED: In general, we found that researchers focus on trunk exoskeleton devices designed for assistance and motor augmentation, which rely more on body movement signals as a source for intention recognition.
    UNASSIGNED: Based on these results, we identify and discuss several promising research directions that may help to attain a widely accepted control methods, thereby advancing further development of trunk exoskeleton technology.
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  • 文章类型: Journal Article
    非洲猪瘟(ASF)一种高度传染性的猪疾病,对养猪业构成了重大的全球威胁。作为一个群岛,菲律宾在ASF传播风险方面具有地理优势。然而,自2019年引入菲律宾以来,它不仅在后院和商业农场,而且在野猪种群中也激增。虽然该国某些地区受到的影响比其他地区更大,ASF的流行病学特征要求必须密切监测所有受影响地区,并对确诊病例给予最大的治疗.菲律宾的ASF流行病学和监测数据非常有限,今后打击ASF的努力必须更加重视改进预防和控制策略。值得一提的是,政府对ASF的全面监测和对可能的ASFV来源或传播途径的流行病学调查是预防和控制ASF暴发的最重要措施。这篇综述文章全面概述了菲律宾目前的养猪业和ASF状况,其中包括它的流行病学,监视,预防,和控制策略。
    African swine fever (ASF), a highly contagious disease of swine, has posed a significant global threat to the swine industry. As an archipelago, the Philippines has a geographic advantage when it comes to the risk of ASF transmission. However, since its introduction to the Philippines in 2019, it has proliferated not only in backyard and commercial farms but also in wild pig populations. While certain parts of the country were more affected than others, the epidemiologic features of ASF necessitate that all affected areas must be closely monitored and that confirmed cases be treated with the utmost care. With the very limited data on ASF epidemiology and surveillance in the Philippines, future efforts to combat ASF must place even greater emphasis on improved prevention and control strategies. It is worth mentioning that the government\'s efforts toward comprehensive ASF surveillance and epidemiological investigation into the possible ASFV sources or transmission pathways are the most important measures in the prevention and control of ASF outbreaks. This review article provides a comprehensive overview of the current swine industry and ASF situation in the Philippines, which includes its epidemiology, surveillance, prevention, and control strategies.
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  • 文章类型: Journal Article
    我国O3污染水平不断上升,显著加剧了O3对健康的长期危害,并且需要针对NOx和VOCs减排的优化健康导向策略。这里,通过合并O3相关死亡率的响应面模型和优化模块,我们开发了O3控制策略的集成评估和优化系统。将该系统应用于长江三角洲(YRD),我们评估了2013年至2017年死亡率变化的驱动因素,量化的时空O3相关死亡率对前体减排的反应,并优化了以健康为导向的控制策略。结果表明,从2013年到2017年,NOx排放减少不足加上VOCs控制不足加剧了与O3相关的死亡率,尤其是在春季和秋季。由于较高的VOC限制特性,北方YRD应促进VOCs控制,而在YRD南部,减少NOx排放更为有利。此外,与无季节差异的控制策略相比,在春季和夏季后期促进NOx减排并在春季和秋季促进VOCs控制可进一步将O3相关死亡率降低近10%。这些发现强调,在空间和时间上区分的NOx和VOCs排放控制策略可以获得更多与O3相关的健康益处,为世界各地臭氧污染严重的地区提供有价值的见解。
    The increasing level of O3 pollution in China significantly exacerbates the long-term O3 health damage, and an optimized health-oriented strategy for NOx and VOCs emission abatement is needed. Here, we developed an integrated evaluation and optimization system for the O3 control strategy by merging a response surface model for the O3-related mortality and an optimization module. Applying this system to the Yangtze River Delta (YRD), we evaluated driving factors for mortality changes from 2013 to 2017, quantified spatial and temporal O3-related mortality responses to precursor emission abatement, and optimized a health-oriented control strategy. Results indicate that insufficient NOx emission abatement combined with deficient VOCs control from 2013 to 2017 aggravated O3-related mortality, particularly during spring and autumn. Northern YRD should promote VOCs control due to higher VOC-limited characteristics, whereas fastening NOx emission abatement is more favorable in southern YRD. Moreover, promotion of NOx mitigation in late spring and summer and facilitating VOCs control in spring and autumn could further reduce O3-related mortality by nearly 10% compared to the control strategy without seasonal differences. These findings highlight that a spatially and temporally differentiated NOx and VOCs emission control strategy could gain more O3-related health benefits, offering valuable insights to regions with severe ozone pollution all over the world.
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  • 文章类型: Journal Article
    质谱(MS)的肽图是生物制药行业中蛋白质表征的重要工具。历史上,肽作图监测蛋白质产物的翻译后修饰(PTM)和开发过程中的中间体。多属性监测(MAM)方法先前已用于商业发布和稳定性测试面板,以确保控制选定的关键质量属性(CQA)。我们的目标是使用MAM方法作为专门针对CQA的整体分析测试策略的一部分,同时去除或替换由于共洗脱而不能有效区分CQAs和非CQAs的历史分离方法。例如,在这项研究中,我们开发了一种策略来替代基于谱的离子交换色谱(IEC)方法,该方法使用MAM方法与传统纯度方法相结合,以确保控制商业抗体(mAb)药物产品(DP)的电荷变体CQAs.为了支持商业测试策略的这一变化,在开发过程中通过高分辨率LC-MS和LC-MS鉴定和表征电荷变体CQAs。电荷变体CQA包括PTM,高分子量物种,和低分子量物种。因此,在QDa系统上使用经过验证的LC-MSMAM方法直接测量电荷变体PTMCQAs,并结合尺寸排阻色谱(SE-HPLC)和毛细管电泳(CE-SDS)测量非PTM电荷变体CQAs,从而从DP规范中去除IEC方法。在MAM之间桥接数据,IEC,和SE-HPLC方法包括在商业营销应用中,以证明从DP规范中删除IEC是合理的。我们还使用该MAM方法作为鉴定测试以减少QC测定的数量。这一战略已得到几个卫生当局的批准。
    Peptide mapping with mass spectrometry (MS) is an important tool for protein characterization in the biopharmaceutical industry. Historically, peptide mapping monitors post-translational modifications (PTMs) of protein products and process intermediates during development. Multi-attribute monitoring (MAM) methods have been used previously in commercial release and stability testing panels to ensure control of selected critical quality attributes (CQAs). Our goal is to use MAM methods as part of an overall analytical testing strategy specifically focused on CQAs, while removing or replacing historical separation methods that do not effectively distinguish CQAs from non-CQAs due to co-elution. For example, in this study, we developed a strategy to replace a profile-based ion-exchange chromatography (IEC) method using a MAM method in combination with traditional purity methods to ensure control of charge variant CQAs for a commercial antibody (mAb) drug product (DP). To support this change in commercial testing strategy, the charge variant CQAs were identified and characterized during development by high-resolution LC-MS and LC-MS/MS. The charge variant CQAs included PTMs, high molecular weight species, and low molecular weight species. Thus, removal of the IEC method from the DP specification was achieved using a validated LC-MS MAM method on a QDa system to directly measure the charge variant PTM CQAs in combination with size exclusion chromatography (SE-HPLC) and capillary electrophoresis (CE-SDS) to measure the non-PTM charge variant CQAs. Bridging data between the MAM, IEC, and SE-HPLC methods were included in the commercial marketing application to justify removing IEC from the DP specification. We have also used this MAM method as a test for identity to reduce the number of QC assays. This strategy has received approvals from several health authorities.
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  • 文章类型: Journal Article
    复杂的相互作用是在非药物干预措施之间进行的,疫苗接种,以及COVID-19传播期间中国大陆所有流行病的宿主。特别是,在目前的研究中,SVEIR模型描述的城市中的小规模流行病较少。建立了具有对照的SVEIR模型,以分析20种措施前后以Omicron变种为主导的锦州市两种流行病的动态和流行病学特征。在这项研究中,锦州市总人口(N)分为五个部分:易感人群(S)、接种疫苗(V),暴露的(E),感染者(I),和回收的(R)。根据监测数据和SVEIR模型,三种方法(最大似然法,指数增长率法,下一代矩阵法)用于估计基本再现数,结果表明,基本复制数从OmicronBA.5.2到OmicronBA.2.12.1有增加的趋势。同时,通过监测数据调查了两种流行病的有效繁殖数,结果表明,锦州第一波在11月1日达到峰值,并在7天后得到控制,而锦州第二波在11月28日达到高峰,并在5天后得到控制。此外,非药物干预的影响(意识延迟,峰值延迟,控制强度)进行了广泛讨论,还讨论了Omicron变体和EG5变体的感染量表的变化。此外,动态零COVID政策中两种流行病的峰值和感染量表调查由SVEIR模型和对照进行.采用SVEIR模型对锦州市和辽宁省的公共医疗需求调查进行了无对照分析,这为未来的变异进化提供了可能的视角。
    The complex interactions were performed among non-pharmaceutical interventions, vaccinations, and hosts for all epidemics in mainland China during the spread of COVID-19. Specially, the small-scale epidemic in the city described by SVEIR model was less found in the current studies. The SVEIR model with control was established to analyze the dynamical and epidemiological features of two epidemics in Jinzhou City led by Omicron variants before and after Twenty Measures. In this study, the total population (N) of Jinzhou City was divided into five compartments: the susceptible (S), the vaccinated (V), the exposed (E), the infected (I), and the recovered (R). By surveillance data and the SVEIR model, three methods (maximum likelihood method, exponential growth rate method, next generation matrix method) were governed to estimate basic reproduction number, and the results showed that an increasing tendency of basic reproduction number from Omicron BA.5.2 to Omicron BA.2.12.1. Meanwhile, the effective reproduction number for two epidemics were investigated by surveillance data, and the results showed that Jinzhou wave 1 reached the peak on November 1 and was controlled 7 days later, and that Jinzhou wave 2 reached the peak on November 28 and was controlled 5 days later. Moreover, the impacts of non-pharmaceutical interventions (awareness delay, peak delay, control intensity) were discussed extensively, the variations of infection scales for Omicron variant and EG.5 variant were also discussed. Furthermore, the investigations on peaks and infection scales for two epidemics in dynamic zero-COVID policy were operated by the SVEIR model with control. The investigations on public medical requirements of Jinzhou City and Liaoning Province were analyzed by using SVEIR model without control, which provided a possible perspective on variant evolution in the future.
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