Search results for "Risk analysis"

Challenge Demands and Resilience

2022

Abstract. This study investigates the relationship of challenge demands (i. e., time pressure, job complexity) on employee resilience. We provide insights into potential pathways (i. e., learning, cognitive irritation) for how challenge stressors influence employee resilience. We employed a two-wave, time-lagged design to examine the influences of challenge stressors and explanatory pathways on employee resilience 2 months later. The data from 359 participants (52.1 % male) were analyzed using a Bayesian time-lagged path model. Results indicate that time pressure and job complexity are negatively related to employee resilience via cognitive irritation. In contrast, we found a positive, ind…

The automated pancreas: A review of technologies and clinical practice

2021

Insulin pumps and glucose sensors are effective in improving diabetes therapy and reducing acute complications. The combination of both devices using an algorithm-driven interoperable controller makes automated insulin delivery (AID) systems possible. Many AID systems have been tested in clinical trials and have proven safety and effectiveness. However, currently, none of these systems are available for routine use in children younger than 6 years in Europe. For continued use, both users and prescribers must have sound knowledge of the features of the individual AID systems. Presently, all systems require various user interactions (e.g. meal announcements) because fully automated systems ar…

Risk analysis in bioequivalence and biowaiver decisions

2013

This article evaluates the current biowaiver guidance documents published by the FDA, EU and WHO from a risk based perspective. The authors introduce the use of a Failure Mode and Effect Analysis (FMEA) risk calculation tool to show that current regulatory documents implicitly limit the risk for bioinequivalence after granting a biowaiver by reduction of the incidence, improving the detection and limiting the severity of any unforeseen bioinequivalent product. In addition, the authors use the risk calculation to expose yet unexplored options for future extension of comparative in vitro tools for biowaivers.

Bioequivalence of oral products and the biopharmaceutics classification system: science, regulation, and public policy.

2011

The demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Biopharmaceutics Classification System (BCS) sets a scientific basis for an improved BE standard for immediate-release solid oral dosage forms. In this paper, we discuss BE and the BCS, as well as the issues that are currently relevant to BE as a pharmaceutical product standard.

Education as a common good from the capability approach

2021

Does Free Will Require Alternative Possibilities?

2017

Abstract In this introductory study I discuss the notion of alternative possibilities and its relation to contemporary debates on free will and moral responsibility. I focus on two issues: whether Frankfurt-style cases refute the principle of alternative possibilities, and whether alternative possibilities are relevant to grounding free will and moral responsibility. With respect to the first issue, I consider three objections to Frankfurt-syle cases: the flicker strategy, the dilemma defense, and the objection from new dispositionalism. With respect to the second issue, I consider the debate between Alternative Possibilities views and Actual Sequence views, as framed by Carolina Sartorio i…

Lateral flow assays (LFA) as an alternative medical diagnosis method for detection of virus species: The intertwine of nanotechnology with sensing st…

2021

Viruses are responsible for multiple infections in humans that impose huge health burdens on individuals and populations worldwide. Therefore, numerous diagnostic methods and strategies have been developed for prevention, management, and decreasing the burden of viral diseases, each having its advantages and limitations. Viral infections are commonly detected using serological and nucleic acid-based methods. However, these conventional and clinical approaches have some limitations that can be resolved by implementing other detector devices. Therefore, the search for sensitive, selective, portable, and costless approaches as efficient alternative clinical methods for point of care testing (P…

Prospects for combining chemical and biological methods for integrated environmental assessment

2009

Abstract Inherently interdisciplinary, environmental assessment applied to contamination is evolving rapidly, despite associated uncertainties in methodologies and data limitations. Mixtures of known and unknown pollutants can cause toxic effects in the environment. Besides deploying a chemicals-driven strategy for the ecological risk assessment of the pollutants, it is necessary to apply and to explore biological strategies. Consequently, bioassays, biosensors and effect-directed analysis (EDA) to identify pollutants responsible of particular effects have become increasingly important. We give a broad overview of how to assess biological monitoring of ecosystems and chemical monitoring of …

The merits and limits of pooling data from nuclear power worker studies

2015

Occupational Safety and Health Risk Assessment in Engineered Nanoparticles Manufacturing Processes

2017

The engineered nanoparticles are more and more entering in Romanian working places, both in research laboratories and in manufacturing processes. Ever increasingly numerous evidence shows that this materials science revolution can generate significant health, safety and environmental hazards, in addition to the social, economic and ethical challenges involvedBased on the precautionary principle recommended be the European Union and a thorough literature review, this research is intended to introduce a framework for further development of an Occupational Health and Safety risk management foundation in this field of concern. Starting from a systematic approach in terms of occupational exposur…