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FAILURE MODES OF PEO BASED ABUSE DETERRENT OPIOIDS AND PROMETHAZINE HYDROCHLORIDE TABLETSSalma Salem (7042751) 15 August 2019 (has links)
<p>Opioid addiction
has become a global epidemic and a national health crisis in recent years. In
2016, approximately 64,000 Americans under 50 years old were killed because of
opioid overdoses. The aim of developing an abuse deterrent opioid is to render
any form of manipulation that encourages abuse challenging and therefore,
non-profitable. With this goal, the Food and Drug Administration (FDA) is
extensively supporting research into the development of abuse deterrent
technologies and prioritizing their production as a public health
necessity. Abuse deterrent approaches include but are not limited to the
following: (1) using a physical
barrier (e.g., Polyethylene oxide PEO) that basically limit the release
of the drugs in the blood or the digestive tract and prevent mechanical
alteration of the drugs by crushing, grating, grinding, chewing etc, (2) using
chemical barriers that employ gelling agents that prevent the aqueous or organic
extraction of the drugs, and (3) combining
the drug with an antagonist that blocks
the post-abuse euphoria.</p>
<p>PEO is a popular
polymer used as a matrix in these complex opioid products. The polymer is
responsible for the abuse deterrent properties as well as extended release
behavior of opioid drugs. PEO hinders the extraction of Opioid drugs from Abuse
Deterrent Formulations (ADF), makes it challenging to be injected, and resists
mechanical stress and pulverization when crushed. PEO can be subjected to thermal processing such as thermal curing,
compression molding, melt extrusion, and injection molding owing to its
thermoplasticity.</p>
<p>Assessment of the
impact of using various manufacturing processes to develop ADFs and the effect
of using various grades of this polymer is essential to improve upon the next
generation of ADFs. There are three main
categories of premarket studies: Category 1 – laboratory based (in-vitro
manipulations and drug extractions), category 2 – pharmacokinetic and category
3 –clinical. These studies are required by the FDA to demonstrate that a given
formulation exhibit abuse deterrent properties before a drug product is
released to the market. In vitro laboratory based manipulation and
extraction studies which are used to assess AD properties of these
products are challenging, but essential for product development and
generic abuse deterrent product approvals. It is important to realize
that there is a great correlation between the laboratory based in vitro
manipulation and extraction studies and the expectations of potential abuse and
misuse of opioid drugs. The ability of these studies to mimic the manipulation
techniques applied by abusers to defeat the abuse deterrent properties of a given
formulation optimizes predictions on post-market abuse and misuse potential of
ADFs. These studies should also correlate well with <i>in-vivo</i> studies since there is a direct correlation with the
concentration (mg/mL in water) and the “high” obtained by an abuser. </p>
<p>This research aimed
to conduct laboratory based in vitro manipulation and extraction studies to investigate
failure modes of PEO-based
prescription opioids and Promethazine Hydrochloride PMZ HCl tablets. It
highlighted the formulation
components and the manufacturing parameters that might affect the dose dumping of
Active Pharmaceutical Ingredients (APIs). Furthermore, this research identified
model compounds that can be used as surrogates for Oxycodone and the best
experimental setup that can be used to conduct smoking simulation experiments.
Moreover, it provided an overview of the societal impacts of the opioid crisis
in the state of Indiana.</p>
<p>Investigations of the
failure modes of the PEO-based prescription opioids and PMZ HCL tablets showed
that physical manipulation techniques via chopping or grinding are much more
effective in the destruction of the PEO matrix than thermal manipulation via
the application of heat thus promoting the fast release. The factor with the most
significant effect on the failure modes of PMZ HCL tablets was the application
of physical manipulation, while the one with the lowest impact was the polymer
grade. Moreover, producing PEO-based matrix tablets
via Direct Compression DC significantly affected dose dumping behavior of the
API from the drug products. The production of the PEO-based matrix tablets via DC
was found to be favored over the usage of the melt extrusion method and molding
techniques. It was clear that DC kept the integrity of the polymer, allowed for
slow and controlled release fashion of the API, and rendered the extraction
process relatively hard compared to the Hot Melt Extrusion HME and Molding
techniques.</p>
<p>Furthermore, the
release profile of the investigated PMZ HCL products consisted of various phases
of polymer swelling and API release. Thermal manipulations via the application
of heat were found to accelerate the dose dumping
behavior (90% release) of the APIs from the compressed, extruded, and molded
PEO-based matrix formulations similarly. On the other hand, heating was
much more effective in the extraction of APIs than chopping or grinding thus
promoting the ability to<b> </b>draw a
solution containing the API into a syringe for injection relatively easy and
facilitate higher % API recovery.</p>
<p>Among the formulation components that might have an
impact on the AD properties of the PEO-based drug products are; the choice of
the antioxidant, the use of complexing agents, chelating agents, and
plasticizers. On the other hand, manufacturing process variables that might
have a critical impact on AD properties of the PEO-based drug products include
but are not limited to; processing temperature compared to the melting point of
the polymer and time of exposure</p>
<p>PMZ HCl was used
as a model drug for Oxycodone in dissolution and extractability studies, while
Caffeine and L-Nicotine were used as model drugs in smoking simulation
experiments. The combination of the propane torch and Kugelrohr apparatus mimic
the real-world scenario for smoking Opioids; however, this experimental setup
caused thermal degradation rather than vaporization of some model drugs.</p>
<p>According to the National
Center for Health Statistics; a statistically significant increase in drug
overdose death rates was reported in 2016 in the state of Indiana among other
states. The number of deaths related to opioid pain relievers increased by 3732
folds in 2017 compared to the number of deaths in 2014. Moreover, Males were
more affected by the opioid crisis than females. On the other hand, the age
group 25-44 years, and white people were the most affected by the opioid crisis
in Indiana. </p>
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Measuring the Effect of Task-Irrelevant Visuals in Augmented RealityAllison C Hopkins (6632282) 14 May 2019 (has links)
<p>Augmented reality (AR) allows people to view digital information overlaid on to real-world objects. While the technology is still new, it is currently being used in places such as the military and industrial assembly operations in the form of ocular devices worn on the head over the eyes. Head-mounted displays (HMDs) let people always see AR information in their field of view no matter where their head is positioned. Studies have shown that HMDs displaying information directly related to the immediate task can decreased cognitive workload and increase the speed and accuracy of task performance. However, task-irrelevant information has shown to decrease performance and accuracy of the primary task and also hinder the efficiency of processing the irrelevant information. This has been investigated in industry settings but less so in an everyday consumer context. This study proposes comparing two types of visual information (text and shapes) in AR displayed on an HMD to answer the following questions: 1) when content is of importance, which visual notification (text or shapes) is processed faster while degrading the performance of the primary task the least? And 2) When presence is of importance, which visual notification (text or shapes) is processed faster while degrading the performance of the primary task the least?</p>
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Incorporating Sustainability Planning in Airport Master Plans: A Case Study of Six U.S Small Hub AirportsCaroline K Marete (6199067) 14 May 2019 (has links)
<div>
<p>The Federal Aviation Administration (FAA) <i>Report on the Sustainable Master Plan Pilot
Program and Lessons Learned </i>published in December 2012 showed that airports
of all sizes can benefit from incorporating sustainability in their master
plans. Global aviation organizations such as the International Civil Aviation
Organization (ICAO) and Airports Council International (ACI) have been in the
forefront in championing aviation sustainability. While incorporating
sustainability in airport planning is highly encouraged, there are challenges
associated with such a process. Some of the challenges experienced by airport
managers in planning and implementation sustainability are lack of financial
capability, and lack of skilled sustainability specialists. In 2009, FAA launched
the Airport Sustainability - Airport Improvement Program (AIP), to provide
grants to airports that were willing to invest the time and resources in
preparing airport master plans that incorporate sustainability issues. To date,
44 airports have been funded through the FAA Airport Sustainability AIP grant.
Six of the 44 airports are in the category of small hub airports as classified
by the National Plan of Integrated Airport Systems (NPIAS). The objective of
this study is to gain an in-depth understanding of the approaches to
sustainability planning used by the six small hub airports in the FAA program.
The researcher chose a case study design to conduct an exploratory case study with
multiple cases. The results of the study show that the approaches used by the
six airports vary depending on the specific airport needs and resources
available. Based on the study results, the researcher concludes there are more
similarities than differences in the approaches airports have used to
incorporate sustainability in the master planning process.</p>
</div>
<br>
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Comparison of global implementations of AUTOSARJason H Stallard (11825012) 18 December 2021 (has links)
<p>Since the incorporation of
electronic controls into automobiles in the 1970s, the complexity of automotive
software has steadily increased. Recent
cars and trucks have more electronics and lines of code than modern
aircraft. This complexity has made the
commoditization of the software exceptionally challenging. The AUTomotive Open System ARchitecture
(AUTOSAR) standard was created to enable original equipment manufacturers
(OEMs), Tier 1 and Tier 2 Suppliers, Vendors, and other players in automotive
software to freely buy, sell, and integrate software components for automotive
applications. AUTOSAR does this through a
standardized set of software interfaces and a methodology for enabling software
exchange, allowing software tools to interoperate. This study explored how AUTOSAR practitioners
go about the business of conducting the methodology and its perceived benefits
and problems. A global survey of AUTOSAR
practitioners was conducted to collect company and respondent demographic
information and details concerning specific practices. The survey results indicated practitioners believe
AUTOSAR was good at abstracting hardware from the software and between the
software components. Respondents also
indicated that the AUTOSAR methodology was complicated and not sufficiently prescriptive,
leading to inconsistent interpretation and application. Based on the survey results, it was concluded
that more work is needed to provide more decisive clarity and direction for
AUTOSAR practitioners.</p>
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Perception of micro-expressions in animated characters with different visual stylesTianyu Hou (11812172) 20 December 2021 (has links)
<div>
<p>The
purpose of this research was to examine the perception of micro-expressions in
animated characters with different visual styles. Specifically, the work
reported in this thesis sought to examine: (1) whether people can recognize
micro-expressions in animated characters, (2) whether there are differences in
recognition based on the character visual style (stylized versus realistic),
(3) the extent to which the degree of exaggeration of micro-expressions affect
the perceived naturalness and intensity of the animated characters’ emotion,
and (4) whether there are differences in effects on perceived naturalness and
intensity based on the character visual style. The research work involved two
experiments: a recognition study and an emotion rating study. A total of 275
participants participated in both experiments. In the recognition study, the
participants watched eight micro-expression animations representing four
different emotions (happy, sad, fear, surprised). Four animations featured a
stylized character and four a realistic character. For each animation, subjects
were asked to identify the character’s emotion conveyed by the
micro-expression. Results showed that all four emotions for both characters
were recognized with an acceptable degree of accuracy. The recognition rates of
the stylized character were 84.73% for happiness, 88.73% for sadness, 60.73%
for fear, and 83.64% surprise. The recognition rates of the realistic character
were 87.37% for happiness, 82.94% for
sadness, 69.62% for fear, and 77.13% for surprise. In the emotion rating
study, participants watched two sets of eight animation clips (16 clips in
total). Eight animations in each set featured the character performing both
macro- and micro-expressions, the different between these two sets was the exaggeration
degree of micro-expressions (normal vs exaggerated). Participants were asked to
recognize the character’s true emotion (conveyed by the micro-expressions) and rate
the naturalness and intensity of the character’s emotion in each clip using a
5-point Likert scale. Findings showed that the <b>degree of exaggeration of the
micro-expressions </b>had a significant effect on <b>emotion’s</b> <b>naturalness
rating</b>, <b>emotion’s</b> <b>intensity rating</b>, and <b>true emotion
recognition</b> and the <b>character visual style</b> had a significant effect
on emotion’s <b>intensity rating</b>. Emotion type, participant gender and
participant animation experience also had significant effects on perception of
the micro-expression.</p>
</div>
<br>
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THE RELATIONSHIP BETWEEN COLLEGE STUDENT CRITIQUE ABILITY AND DESIGN ABILITYCameron Moon (8097956) 11 December 2019 (has links)
While industry is looking to graphic design education for the next top designers who have the knowledge and skills to be successful in their field (Bridges, King, Brown, & Luedeman, 2013), graphic design instructors often have a limited time to teach students the knowledge and skills they need to become successful designers (Landa, 2010; Kennedy et al., 2012; Liu, & Tourtellott, 2011). Most university-level graphic design courses, the traditional preparation pathway for future designers, focus on improving student’s design ability through hands-on projects that teach students how to use graphic design technology (Motley, 2017). In addition to hands-on graphic design experiences, many classrooms also use peer critique to allow students to critique and give feedback to peers while identifying the positive aspects of a design and suggesting improvements to be made (Motley, 2017). Students tend to improve their design when a classroom implements critique, including self and peer assessment, into the curriculum (Wanner, & Palmer, 2018). However, little is known about the relationship, if any exists, between a student’s ability to design and a student’s ability to critique. Therefore, this study will investigate the correlation between student critique and student design abilities with the intent of improving graphic design educational practices. Understanding this correlation may assist those involved with graphic design education to better prepare students for future employment by assisting instructors in using their limited teaching time most effectively. Specifically, a relationship between graphic design critique and graphic design skill may suggest that the limited time available for teaching should emphasize improving critique skills with the goal of also improving graphic design abilities. If no relationship between critique and design abilities exists, this may suggest that limited time should be spent engaging students in critique and other forms of teaching should be emphasized.
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THE OPTIMIZATION OF THE ELECTRICAL SYSTEM VOLTAGE RANGE OF MILD HYBRID ELECTRIC VEHICLEYansong Chen (7036457) 16 December 2020 (has links)
<p>The optimization of the electrical system voltage range of a mild hybrid
electric vehicle is examined in this research study. The objective is to
evaluate and propose the optimized vehicle voltage level for the mild hybrid
electric vehicle from both technical and economic aspects. The approach is to
evaluate the fuel economy improvement from the mild hybrid electric vehicle of
various voltage level for the cost benefit study. The evaluation is conducted
from the vehicle system level with discussions of components selection for
system optimization. Autonomie, a simulation tool widely used by academic and
automotive industry, is used for the vehicle simulation and fuel economy
evaluation. The cost analysis is based on the system cost factoring in the
component cost based forecasted production volume. </p>
<p>The driver for this study is to propose an optimized voltage for the
mild hybrid electric vehicle for the vehicle manufacturers and suppliers to
standardize the implementation to meet the fuel economy and emission requirements
and vehicle power demand. The standardization of the vehicle voltage level can
improve design and development efficiency, reusability and reduce cost in
developing non-standard voltage levels of the mild hybrid vehicle. The synergy
in standardized voltage level for the mild hybrid vehicle can accelerate
technology implementation toward mass production to meet regulatory emission
and fuel economy requirements. </p>
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Emotionally Unstable Personality Traits as Predictors for Traditional and Digital Forms of Non-Suicidal Self-InjuryDaniel Song Shao (9175622) 30 July 2020 (has links)
<p>The area of research that was investigated for this study is self-harm, which is also known as non-suicidal self-injury (NSSI). NSSI can be defined as self-injury with no intention of dying. Examples of NSSI are the cutting of one’s skin or banging one’s head against the wall to the point of bruising. Digital self-harm (DSH) can be defined as cyberbullying directed at oneself. DSH is an area within NSSI and self-harm that has not been extensively studied. However, its consequences have already been fatal; in 2013, a 14-year-old suicide in the United Kingdom was linked to DSH. In this case, DSH manifested itself by masking as cyberbullying, when instead it was the individual themselves who was behind the malicious comments. Research shows that there are several risk factors for NSSI, one of which includes borderline personality disorder (BPD). BPD is a type of personality disorder that consists of impulsive and volatile mood. A high percentage of individuals diagnosed with BPD have been found to engage in NSSI. The current study conducted an anonymous Internet survey that measured the following variables: engagement in NSSI, engagement in DSH, what types of NSSI/DSH were engaged in, personality traits, and interpersonal/intrapersonal functions for engaging in NSSI or DSH. The study revealed that among freshmen at a large, Midwestern university (<i>N</i> = 112), individuals who engaged in NSSI were significantly more likely to engage in DSH. The sample included 61 (55%) of students who self-reported engaging in NSSI and 17 (15%) of students who reported engaging in DSH. However, the study did not find that all BPD personality traits correlated with individuals who engaged in DSH. Personality facets and functioning were similar among DSH and NSSI. Differences were found in levels of reinforcement function between individuals who engaged in DSH and NSSI. These results suggested a relationship between DSH behavior and BPD features, as well as the use of maladaptive strategies for self-regulating emotion. The authors conclude that future research should investigate different types of DSH and encourages clinical practitioners to include online behavior questionnaires in their evaluations of at-risk adolescents.</p>
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TOWARDS A SHIPYARD 4.0: A CASE STUDY ON THE INTENDED UTILIZATION OF DIGITAL TRANSFORMATION AND INDUSTRY 4.0 MECHANISMS IN A COLOMBIAN SHIPYARDAsmett Barrios Morales (10711242) 29 April 2021 (has links)
As digital transformation and Industry 4.0 have become a path for organizations to strengthen their performance, create value and acquire competitive advantages in different industries and regions, its appeal has increased among companies from diverse sectors and government institutions in the Colombian economy, but limited generalizability and replicability has been found in current models, which pose difficulties for their translation into the Colombian shipyard industry. Thus, this research study assessed the pertinence of utilizing digital transformation and industry 4.0 technologies as an enabler for the achievement of organizational goals, while focusing on the Colombian shipyard industry. To do so, a case study with mixed methods approach was utilized to collect data from interviews and surveys with the members of a Colombian Shipyard; which after applying analytical procedures and techniques, yielded the existence of an alignment between the Industry 4.0 and the achievement of their operational goals, as well as the identification of the strengths, challenges and implications of deploying digital technologies and a digital transformation strategy for a Colombian shipyard. Moreover, this study contributed to the understanding of digital transformation processes in relation to the specific characteristic, metrics, and factors of the Colombian shipyard industry, and it is a step forward into the further development of applications within different Colombian sectors by academics and practitioners in the field.
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BUILDING RESILIENT SUPPLY CHAINS THROUGH SUPPLY CHAIN DIGITAL TWIN: AN EXPLORATIVE STUDY IN US MANUFACTURING SUPPLY CHAINSSenthilkumar Thiyagarajan (11462140) 19 April 2022 (has links)
<p>Developing resiliency in supply chains became vital in the recent years due to global diversification and vulnerability to risks. Firms need to identify, evaluate, and mitigate risks in supply chain to maintain continuity and create competitive advantage. Although the problem of supply chain disruptions has existed for a long time, less attention has been given by researchers in exploring the adoption of advanced technologies to build resilient supply chains. This study explored the potential of mitigating supply chain disruptions with the use of Industry 4.0 technologies such as Internet of Things (IoT) and Supply chain data analytics platform which develops digital twin environment for supply chains. </p>
<p><br></p>
<p>This research gathered expert’s opinion on the resilience capabilities developed in supply chain by digital twin adoption, stages and practices involved in digital twin assimilation through Delphi survey with subject matter experts and supply chain practitioners. Semi-structured interviews were conducted with participants to attain deep understanding on the resilience capabilities gained by digital twin and stages in digital twin adoption. Comparison of the results from Delphi survey and interviews was carried out to synthesize the results to yield a comprehensive understanding of resilience capabilities gained through digital twin and adoption stages of supply chain digital twin. This research has conducted interviews with 21 subject matter experts and completed three rounds of Delphi survey (with participants n = 15, 11, 11 in three rounds respectively) to develop a framework for digital twin adoption to enhance supply chain resilience. </p>
<p><br></p>
<p>This research determined that digital twin develops real-time monitoring and sensing capabilities, planning and decision support system, and automating decisions and action execution capabilities in supply chain. In addition, digital twin positively impacts resilience elements such as agility, supply chain reconfiguration, robustness, and collaboration in supply chain, which improves the supply chain performance. The results from this study were utilized to develop a framework for enabling supply chain resilience through digital twin. The framework included antecedents, consequences, and various moderators that impact digital twin adoption and diffusion in supply chains. Finally, this research developed a five-stage roadmap for adopting digital twin capabilities in supply chain. </p>
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