Ensuring biological sample integrity from collection to analysis for LC–MS workflows: case studies illustrating challenges in clinical trials

Bioanalysis ◽  
2019 ◽  
Vol 11 (20) ◽  
pp. 1859-1866 ◽  
Author(s):  
Melanie Anderson
Keyword(s):  
Clinical Trials ◽  
Life Cycle ◽  
Case Studies ◽  
Environmental Exposure ◽  
Biological Sample ◽  
Reliable Data ◽  
Central Laboratory ◽  
Exposure Temperature ◽  
Sample Stability ◽  
Internal Operations

In quantitative bioanalysis, ensuring sample integrity through the life cycle of a sample is crucial for providing reliable data. Sponsors must develop proper collection procedures to ensure high sample quality. Collection procedures should mitigate sample variability and stability concerns. Sample stability concerns can be managed with appropriate stabilization approaches like the addition of preservative, environmental exposure (temperature, humidity, light controls) and timely analysis with more frequent shipping. It is important that the bioanalytical scientist communicates specific needs to internal operations groups, the central laboratory and clinical sites. In large global trials, this is logistically challenging given the large number of sites and the potential language barriers. Several case studies presented below will illustrate logistical challenges with unstable compounds and unique matrices for LC–MS/MS workflows.

Software-driven Security Attacks: From Vulnerability Sources to Durable Hardware Defenses

2021 ◽  
Vol 17 (3) ◽  
pp. 1-38
Author(s):  
Lauren Biernacki ◽  
Mark Gallagher ◽  
Zhixing Xu ◽  
Misiker Tadesse Aga ◽  
Austin Harris ◽  
...  
Keyword(s):  
Life Cycle ◽  
Case Studies ◽  
Gain Control ◽  
Illustrative Case ◽  
Security Attacks ◽  
Specific Point ◽  
Security Vulnerabilities ◽  
Significant Challenge ◽  
Hardware Realization ◽  
Over Time

There is an increasing body of work in the area of hardware defenses for software-driven security attacks. A significant challenge in developing these defenses is that the space of security vulnerabilities and exploits is large and not fully understood. This results in specific point defenses that aim to patch particular vulnerabilities. While these defenses are valuable, they are often blindsided by fresh attacks that exploit new vulnerabilities. This article aims to address this issue by suggesting ways to make future defenses more durable based on an organization of security vulnerabilities as they arise throughout the program life cycle. We classify these vulnerability sources through programming, compilation, and hardware realization, and we show how each source introduces unintended states and transitions into the implementation. Further, we show how security exploits gain control by moving the implementation to an unintended state using knowledge of these sources and how defenses work to prevent these transitions. This framework of analyzing vulnerability sources, exploits, and defenses provides insights into developing durable defenses that could defend against broader categories of exploits. We present illustrative case studies of four important attack genealogies—showing how they fit into the presented framework and how the sophistication of the exploits and defenses have evolved over time, providing us insights for the future.

scholarly journals Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies

Healthcare ◽  
2021 ◽  
Vol 8 ◽  
pp. 100432
Author(s):  
Leah Tuzzio ◽  
Catherine M. Meyers ◽  
Laura M. Dember ◽  
Corita R. Grudzen ◽  
Edward R. Melnick ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Quality Improvement ◽  
Case Studies ◽  
Healthcare Systems ◽  
Pragmatic Clinical Trials

Oral contraceptives and psychological symptoms

1969 ◽  
Vol 7 (1) ◽  
pp. 2-4
Keyword(s):  
Clinical Trials ◽  
Oral Contraceptives ◽  
Psychological Symptoms ◽  
Good Evidence ◽  
Reliable Data ◽  
Intermediary Metabolism ◽  
Control Groups ◽  
Cerebral Activity ◽  
The Brain

Psychological symptoms are notoriously difficult to assess, and it is not surprising that the reported incidence of such symptoms in women taking oral contraceptives varies widely. The apparent incidence may further be influenced by what the subjects think they are expected to say. Clinical trials of oral contraceptives where psychological symptoms have been specifically studied provide the most reliable data, but control groups have so far been examined in only a few trials. Data on such symptoms from trials where unwanted effects were merely noted in passing are unreliable. There is however good evidence that synthetic progestagens influence cerebral activity1–3 and intermediary metabolism in the brain4 in both women and animals and that these effects do not mimic those of pregnancy.

A systematic review of life cycle assessment of hydrogen for road transport use

2021 ◽  
Author(s):  
Dyah Ika Rinawati ◽  
Alexander Ryota Keeley ◽  
Shutaro Takeda ◽  
Shunsuke Managi
Keyword(s):  
Life Cycle Assessment ◽  
Life Cycle ◽  
Hydrogen Production ◽  
Case Studies ◽  
Large Scale ◽  
Road Transport ◽  
Fuel Cell Vehicle ◽  
Intergovernmental Panel ◽  
Hybrid Lca ◽  
Complete Life Cycle

Abstract This study conducted a systematic literature review of the technical aspects and methodological choices in life cycle assessment (LCA) studies of using hydrogen for road transport. More than 70 scientific papers published during 2000–2021 were reviewed, in which more than 350 case studies of use of hydrogen in the automotive sector were found. Only some studies used hybrid LCA and energetic input-output LCA, whereas most studies addressed attributional process-based LCA. A categorization based on the life cycle scope distinguished case studies that addressed the well-to-tank (WTT), well-to-wheel (WTW), and complete life cycle approaches. Furthermore, based on the hydrogen production process, these case studies were classified into four categories: thermochemical, electrochemical, thermal-electrochemical, and biochemical. Moreover, based on the hydrogen production site, the case studies were classified as centralized, on-site, and on-board. The fuel cell vehicle passenger car was the most commonly used vehicle. The functional unit for the WTT studies was mostly mass or energy, and vehicle distance for the WTW and complete life cycle studies. Global warming potential (GWP) and energy consumption were the most influential categories. Apart from the GREET (Greenhouse Gases, Regulated Emissions, and Energy Use in Transportation) model and the Intergovernmental Panel on Climate Change for assessing the GWP, the Centrum voor Milieukunde Leiden method was most widely used in other impact categories. Most of the articles under review were comparative LCA studies on different hydrogen pathways and powertrains. The findings provide baseline data not only for large-scale applications, but also for improving the efficiency of hydrogen use in road transport.

scholarly journals Strategies to Improve the Energy Performance of Buildings: A Review of Their Life Cycle Impact

Buildings ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. 105 ◽  
Author(s):  
Nadia MIRABELLA ◽  
Martin RÖCK ◽  
Marcella Ruschi Mendes SAADE ◽  
Carolin SPIRINCKX ◽  
Marc BOSMANS ◽  
...  
Keyword(s):  
Life Cycle ◽  
Case Studies ◽  
Environmental Impacts ◽  
Energy Use ◽  
Ghg Emissions ◽  
Energy Performance ◽  
Environmental Benefits ◽  
Embodied Energy ◽  
Trade Offs ◽  
Operational Energy

Globally, the building sector is responsible for more than 40% of energy use and it contributes approximately 30% of the global Greenhouse Gas (GHG) emissions. This high contribution stimulates research and policies to reduce the operational energy use and related GHG emissions of buildings. However, the environmental impacts of buildings can extend wide beyond the operational phase, and the portion of impacts related to the embodied energy of the building becomes relatively more important in low energy buildings. Therefore, the goal of the research is gaining insights into the environmental impacts of various building strategies for energy efficiency requirements compared to the life cycle environmental impacts of the whole building. The goal is to detect and investigate existing trade-offs in current approaches and solutions proposed by the research community. A literature review is driven by six fundamental and specific research questions (RQs), and performed based on two main tasks: (i) selection of literature studies, and (ii) critical analysis of the selected studies in line with the RQs. A final sample of 59 papers and 178 case studies has been collected, and key criteria are systematically analysed in a matrix. The study reveals that the high heterogeneity of the case studies makes it difficult to compare these in a straightforward way, but it allows to provide an overview of current methodological challenges and research gaps. Furthermore, the most complete studies provide valuable insights in the environmental benefits of the identified energy performance strategies over the building life cycle, but also shows the risk of burden shifting if only operational energy use is focused on, or when a limited number of environmental impact categories are assessed.

scholarly journals Blockchain in Health Care Innovation: Literature Review and Case Study From a Business Ecosystem Perspective (Preprint)

2020 ◽  
Author(s):  
Shuchih Ernest Chang ◽  
YiChian Chen
Keyword(s):  
Health Care ◽  
Life Cycle ◽  
Literature Review ◽  
Case Studies ◽  
Paradigm Shift ◽  
Potential Health ◽  
Business Ecosystem ◽  
Blockchain Technology ◽  
The Impact

BACKGROUND Blockchain technology is leveraging its innovative potential in various sectors and its transformation of business-related processes has drawn much attention. Topics of research interest have focused on medical and health care applications, while research implications have generally concluded in system design, literature reviews, and case studies. However, a general overview and knowledge about the impact on the health care ecosystem is limited. OBJECTIVE This paper explores a potential paradigm shift and ecosystem evolution in health care utilizing blockchain technology. METHODS A literature review with a case study on a pioneering initiative was conducted. With a systematic life cycle analysis, this study sheds light on the evolutionary development of blockchain in health care scenarios and its interactive relationship among stakeholders. RESULTS Four stages—birth, expansion, leadership, and self-renewal or death—in the life cycle of the business ecosystem were explored to elucidate the evolving trajectories of blockchain-based health care implementation. Focused impacts on the traditional health care industry are highlighted within each stage to further support the potential health care paradigm shift in the future. CONCLUSIONS This paper enriches the existing body of literature in this field by illustrating the potential of blockchain in fulfilling stakeholders’ needs and elucidating the phenomenon of coevolution within the health care ecosystem. Blockchain not only catalyzes the interactions among players but also facilitates the formation of the ecosystem life cycle. The collaborative network linked by blockchain may play a critical role on value creation, transfer, and sharing among the health care community. Future efforts may focus on empirical or case studies to validate the proposed evolution of the health care ecosystem.

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