Quality-by-design approach for the development of telmisartan potassium tablets

A quality-by-design approach was adopted to develop telmisartan potassium (TP) tablets, which were bioequivalent with the commercially available Micardis^® (telmisartan free base) tablets. The dissolution pattern and impurity profile of TP tablets differed from those of Micardis^® tablets because telmisartan free base is poorly soluble in water. After identifying the quality target product profile and critical quality attributes (CQAs), drug dissolution, and impurities were predicted to be risky CQAs. To determine the exact range and cause of risks, we used the risk assessment (RA) tools, preliminary hazard analysis and failure mode and effect analysis to determine the parameters affecting drug dissolution, impurities, and formulation. The range of the design space was optimized using the face-centered central composite design among the design of experiment (DOE) methods. The binder, disintegrant, and kneading time in the wet granulation were identified as X values affecting Y values (disintegration, hardness, friability, dissolution, and impurities). After determining the design space with the desired Y values, the TP tablets were formulated and their dissolution pattern was compared with that of the reference tablet. The selected TP tablet formulated using design space showed a similar dissolution to that of Micardis^® tablets at pH 7.5. The QbD approach TP tablet was bioequivalent to Micardis^® tablets in beagle dogs.     

探究地质矿产勘查风险原因的分析及应对对策

我国有许多种类的地质矿产资源,地质矿产资源的勘查与开发有效地促进了我国工业生产的进步。整个社会的发展对于地质矿产资源的需求也非常高,所以必须开展高效的矿产资源勘查活动。但是目前地质矿产资源勘查中经常会存在一系列的风险,会对勘查人员及整个矿床造成不同程度的损害。相关企业必须采取有效的应对策略,有效降低企业的勘查风险。本文主要是基于地质矿产勘查风险原因的分析及应对策略两方面来展开进一步论述的。     

Cross-sector collaboration within Dutch flood risk governance: historical analysis of external triggers

ABSTRACT

This article synthesizes the literature on Dutch flood risk governance to analyze how external conditions shaped past and present dynamics of cross-sector collaboration for integrated flood risk management in the Netherlands. It traces the extent to which policy and legal frameworks, socio-economic circumstances, political realities, power relations and conflict situations have influenced attempts at collaboration between flood safety, spatial planning, environmental protection and other sectors. Despite the growing interdependences, existing power relations between the sectors are characterized by the dominance of the water sector. Hence, cross-sector collaboration can develop as long as it does not compromise flood safety.     

浅议生态环境监测机构的风险控制

现阶段,为了探索创新性的发展途径,生态环境监测机构应始终增强风险控制意识。应加强风险管理,立足于风险控制,以求不断健康发展。     

A quantitative risk assessment of a domestic property connected to a hydrogen distribution network

The increased reliance on natural gas for heating worldwide makes the search for carbon-free alternatives imperative, especially if international decarbonisation targets are to be met. Hydrogen does not release carbon dioxide (CO₂) at the point of use which makes it an appealing candidate to decarbonise domestic heating. Hydrogen can be produced from either 1) the electrolysis of water with no associated carbon emissions, or 2) from methane reformation (using steam) which produces CO₂, but which is easily captured and storable during production. Hydrogen could be transported to the end-user via gas distribution networks similar to, and adapted from, those in use today. This would reduce both installation costs and end-user disruption. However, before hydrogen can provide domestic heat, it is necessary to assess the ‘risk’ associated with its distribution in direct comparison to natural gas. Here we develop a comprehensive and multi-faceted quantitative risk assessment tool to assess the difference in ‘risk’ between current natural gas distribution networks, and the potential conversion to a hydrogen based system. The approach uses novel experimental and modelling work, scientific literature, and findings from historic large scale testing programmes. As a case study, the risk assessment tool is applied to the newly proposed H100 demonstration (100% hydrogen network) project. The assessment includes the comparative risk of gas releases both upstream and downstream of the domestic gas meter. This research finds that the risk associated with the proposed H100 network (based on its current design) is lower than that of the existing natural gas network by a factor 0.88.     

The introduction strategy of the emerging online marketplace considering risk attitude and channel power

With the development of online retailing, traditional online platforms have begun to offer a novel online marketplace format that brings many advantages but also gives rise to problems such as operational risks and changes in channel power. This paper studies whether the e-tailer and manufacturer can reach a consensus on introducing the marketplace channel and obtains the following insights. First, the manufacturer always prefers to introduce the online marketplace in the model where she acts as the leader. The e-tailer has the same preference for the online marketplace when he moves later or simultaneously with the manufacturer. Second, as the participants become more risk-averse, the manufacturer and e-tailer would be less willing to introduce the online marketplace, and it would be more difficult to realize the equilibrium strategy under all power structure models. Third, by combining the cross-effect of the attitude towards risks and the power structure, we find that when the participants prefer risks and the e-tailer has strong channel power, it would be much easier for the two parties to reach a consensus about introducing the online marketplace.     

透视中国综合防灾减灾的主要进展及其挑战和战略对策

系统总结中国自然灾害风险主要特点和综合防灾减灾工作的现状特征,全面梳理综合防灾减灾工作的发展趋势,分析综合防灾减灾面临的三大挑战,提出有针对性和可实施性的五大战略对策。一方面,未来100年中国的气候变暖趋势将进一步加剧,极端天气事件发生的频率将增大,荒漠化、海平面上升、冰川退缩趋势将进一步加重,全球气候变化所引发的各类巨灾和由此触发的各类自然灾害的突发性、并发性、群发性、异常性日益凸显。另一方面,中国能源结构以煤为主,同时是世界上进口石油资源的大国,随着中国经济的发展,未来能源消费和二氧化碳排放量还将持续增长,经济社会发展对能源安全、粮食安全、生态安全提出了更高要求。为适应气候变化背景下的各类灾害带来的不利影响,中国应全面提高监测预警水平,建立综合防灾减灾体系,全面提高应对突发灾害和巨灾的应急能力;推动建立区域综合防灾减灾范式,系统实施绿色经济战略,大力推进节能减排,转变经济发展方式。     

Ergonomics interventions to reduce musculoskeletal risk factors in a truck manufacturing plant

Ergonomic interventions may potentially reduce MSDs, but the context of industries (barriers, ever-changing situations, dialogue processes) might play a significant role in the success of interventions. This study evaluates the effectiveness of ergonomic interventions including engineering/technical and organizational interventions, and the involvement of the stakeholders in reducing musculoskeletal risk factors/symptoms. A pre-post-test experimental study in non-randomized groups was performed over three years in a sector of a truck assembly plant. The mean age of the operators in the sector for the initial and second assessment time was 42.0 (±7.6) years and 39.0 (±8.7), respectively. The mean length of work experience in the current job was 15.2 (±7.2) years and 13.9 (±7.3) for the initial and second assessment times, respectively. Five engineering ergonomic solutions and organizational interventions were implemented after a comprehensive ergonomic analysis. The organizational interventions consisted mostly of transferring and redistributing the tasks, i.e., ergonomically balancing and redesigning of the workstations. Before performing the interventions, the findings of the ergonomic study were presented at several meetings to encourage the involvement of the stakeholders (including managers, engineers, and operators) in the interventions. This study showed that a combination of ergonomic measures—engineering and organizational interventions—could reduce physical workloads. Musculoskeletal symptoms decreased after interventions although the difference was not significant.     

Airborne spread of expiratory droplet nuclei between the occupants of indoor environments: A review

This article reviews past studies of airborne transmission between occupants in indoor environments, focusing on the spread of expiratory droplet nuclei from mouth/nose to mouth/nose for non‐specific diseases. Special attention is paid to summarizing what is known about the influential factors, the inappropriate simplifications of the thermofluid boundary conditions of thermal manikins, the challenges facing the available experimental techniques, and the limitations of available evaluation methods. Secondary issues are highlighted, and some new ways to improve our understanding of airborne transmission indoors are provided. The characteristics of airborne spread of expiratory droplet nuclei between occupants, which are influenced correlatively by both environmental and personal factors, were widely revealed under steady‐state conditions. Owing to the different boundary conditions used, some inconsistent findings on specific influential factors have been published. The available instrumentation was too slow to provide accurate concentration profiles for time‐dependent evaluations of events with obvious time characteristics, while computational fluid dynamics (CFD) studies were mainly performed in the framework of inherently steady Reynolds‐averaged Navier‐Stokes modeling. Future research needs in 3 areas are identified: the importance of the direction of indoor airflow patterns, the dynamics of airborne transmission, and the application of CFD simulations.