Digital Commons Network^™

Introducing A Model And A Framework To Unify The Pharmaceutical Quality System Enablers Quality Risk Management & Knowledge Management, Martin J. Lipa, Kevin O'Donnell, Anne Greene

Articles

An organization that effectively manages knowledge should be able to recognize and proactively apply new learnings to better anticipate risks. This is particularly important in the manufacture of medicinal products. Since the publication of ICH Q10 in 2010, Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System. The authors of this paper present a Knowledge Management process model to foster greater practical understanding of the practice of knowledge management. This model when joined with the familiar ICH Q9 process model for QRM, should enable a company to better manage their knowledge …

Structural Annotation Of Electro- And Photochemically Generated Transformation Products Of Moxidectin Using High-Resolution Mass Spectrometry, Lisa Kotthoff, Sarah-Louise O'Callaghan, Jan Lisec, Tanja Schwerdtle, Matthias Koch

Articles

Moxidectin (MOX) is a widely used anthelmintic drug for the treatment of internal and external parasites in food-producing and companion animals. Transformation products (TPs) of MOX, formed through metabolic degradation or acid hydrolysis, may pose a potential environmental risk, but only few were identified so far. In this study, we therefore systematically characterized electro- and photochemically generated MOX TPs using high-resolution mass spectrometry (HRMS). Oxidative electrochemical (EC) TPs were generated in an electrochemical reactor and photochemical (PC) TPs by irradiation with UV-C light. Subsequent HRMS measurements were performed to identify accurate masses and deduce occurring modification reactions of derived TPs …

September 2019 Therapeutic Delivery Update, Elaine Harris

Articles

No abstract provided.

Determination Of Upconversion Quantum Yields Using Charge-Transfer State Fluorescence Of Heavy-Atom-Free Sensitizer As A Self-Reference, Natalia Kiseleva, Dmitry Busko, Bryce Richards, Mikhail Filatov, Andrey Turshatov

Articles

The efficiency of photon upconversion via triplet–triplet annihilation is characterized by an upconversion quantum yield (Φ_UC); however, uncertainties remain for its determination. Here, we present a new approach for the relative measurement of Φ_UC for green-to-blue upconversion using BODIPY–pyrene donor–acceptor dyad (BD1) as a heavy-atom-free triplet sensitizer. This new approach exploits broad fluorescence from a charge-transfer (CT) state of BD1, which possesses (i) a significant Stokes shift of 181 nm in dichloromethane and (ii) a comparably high CT-fluorescence quantum yield (Φ_ref = 7.0 ± 0.2%), which is independent from oxygen presence and emitter (perylene) concentration while …

How Fishy Is Your Fish? Authentication, Provenance And Traceability In Fish And Seafood By Means Of Vibrational Spectroscopy, Aoife Power, Daniel Cozzolino

Articles

Food authenticity, traceability and provenance are emerging issues of major concern forconsumers, industries and regulatory bodies worldwide. In addition, both food safety and securityare an intrinsic component of food quality where the above issues are key in modern traceabilityand management systems. It has been reported that substitution of a high-quality species by lessexpensive ones might be a frequent practice in seafood products such as fish and shellfish. In thistype of products, the source (e.g., origin) and identification of the species are complex. Althoughdifferent countries have implemented strict regulations and labelling protocols, these issues still are ofconcern. This article briefly reviews …

Author Correction: Biopharmaceutical Revolution In Saudi Arabia: Progress And Development, Elaine Harris

Articles

The original version of this article unfortunately contained a mistake. The affiliation of Rihana Alzahrani was incorrectly captured as “Bisha University”. The correct affiliation of Rihana Alzahrani is “Technological University Dublin.” The email address of Elaine Harris is also updated to “[email protected].” The original article has been corrected.

Microfluidic Flow Direction And Rate Vector Sensor Based On A Partially Gold-Coated Tfbg, Changyu Shen, Dejun Liu, Xiaokang Lian, Tingting Lang, Chunliu Zhao, Yuliya Semenova, Jacques Albert

Articles

In microfluidic chips applications, the monitoring of the rate and the direction of a microfluidic flow is very important. Here, we demonstrate a liquid flow rate and a direction sensor using a partially gold-coated tilted fiber Bragg grating (TFBG) as the sensing element. Wavelength shifts and amplitude changes of the TFBG transmission resonances in the near infrared reveal the direction of the liquid flowing along the fiber axis in the vicinity of the TFBG due to a nanoscale gold layer over part of the TFBG. For a device length of 10 mm (and a diameter of 125 µm for easy …

The Perils Of Pandemic Exceptionalism, Julian Arato, Kathleen Claussen, J. Benton Heath

Articles

In response to the pandemic, most states have enacted special measures to protect national economies and public health. Many of these measures would likely violate trade and investment disciplines unless they qualify for one of several exceptions. This Essay examines the structural implications of widespread anticipated defenses premised on the idea of “exceptionalism.” It argues that the pandemic reveals the structural weakness of the exceptions-oriented paradigm of justification in international economic law.

International Law And Theories Of Global Justice: Remarks, Steven R. Ratner, James Stewart, Jiewuh Song, Carmen Pavel

Articles

International law (IL) and political philosophy represent two rich disciplines for exploring issues of global justice. At their core, each seeks to build a better world based on some universally agreed norms, rules, and practices, backed by effective institutions. International lawyers, even the most positivist of them, have some underlying assumptions about a just world order that predisposes their interpretive methods; legal scholars have incorporated concepts of justice in their work even as their overall pragmatic orientation has limited the nature of their inquiries. Many philospophers, for their part, have engaged with IL to some extent—at a minimum recognizing that …

What Litigators Can Learn From B Movies, Leonard M. Niehoff

Articles

We litigators take our guidance when and where we can find it. Sometimes we stumble across it very late at night, on television. Weary, intellectually spent, and pining for entertainment that makes no demands on us, in "the wee small hours of the morning" we find ourselves watching a so-called B movie - a film that had a low production budget or that manages to be bad despite an ample one. And, lo, enlightenment ensues through this unlikeliest of messengers. Submitted for your consideration are some gems from half a dozen movies that most sensible people won't admit watching but …

Proof At The Salem Witch Trials, Leonard M. Niehoff

Articles

As of the writing of this article, President Donald Trump's tweets have included roughly 400 references to "witch hunts." In a sense, this is unsurprising. The Salem witch trials have a special place in our national identity and vocabulary. Most Americans understand the reference, even if they know few of the historical details. And the phrase "witch hunt" serves as a useful shorthand for any frenzied chase after something that does not exist. The Salem trials also inspire a peculiar fascination: Perhaps no other site of deadly mass hysteria has become a major tourist destination.

Still, most practicing litigators probably …

Before The Cell Door Shuts: Justice Reform Efforts Should Focus On Steps Besides Sentencing, Barbara L. Mcquade

Articles

Mark Osler writes that criminal justice reform efforts have been hampered by what he calls “the slows.” He explains that despite bipartisan support, which resulted in the First Step Act of 2018,2 criminal justice reform remains elusive. He then offers some insightful suggestions for how to increase the pace.

When Mini-Publics And Maxi-Publics Coincide: Ireland’S National Debate On Abortion, David M. Farrell, Jane Suiter, Kevin Cunningham, Clodagh Harris

Articles

Ireland’s Citizens’ Assembly (CA) of 2016–18 was tasked with making recommendations on abortion. This paper shows that from the outset its members were in large part in favour of the liberalisation of abortion (though a fair proportion were undecided), that over the course of its deliberations the CA as a whole moved in a more liberal direction on the issue, but that its position was largely reflected in the subsequent referendum vote by the population as a whole.

A Comparison Of Radiobiological Response In Cells Exposed To Low Let Radiation With Different Beam Energies, Lisa White, Laura Shields, Orla Howe, Isabel Vega Carrascal, Adrian Maguire, Aidan Meade, Brendan Mcclean, Fiona M. Lyng

Articles

There is conflicting evidence in the literature on biological effects between different low LET radiations. The aim of this study was to investigate the impact of different low LET radiations on radiobiological response. Chromosomal radiosensitivity was measured in human lymphocytes from healthy donors using the G2 chromosomal radiosensitivity assay. Radiation induced mitotic inhibition was also measured. Cells were irradiated to doses of 0.05 and 0.5 Gy using a Cobalt 60 teletherapy unit and a Linac operating at 6 MV (photons) and 12 MeV (electrons). As expected, a dose response was observed with increasing dose resulting in greater response. No statistically …

Some Musings As Llcs Approach The Fifty-Year Milestone, Susan Pace Hamill

Articles

No abstract provided.

The Law Of Rescue, Shalini Bhargava Ray

Articles

Diverse areas of law regulate acts of rescue, often inconsistently. For example, maritime law mandates rescue, immigrant harboring law prohibits it, and tort law generally permits it but does not require it. Modern legal scholarship has focused principally on mandatory and permissive forms of rescue. With humanitarian actors facing prosecution for saving migrants' lives in the Arizona desert and elsewhere, however, scholarly treatment of the phenomenon of prohibited rescue is increasingly urgent. By analyzing disparate regimes of rescue, and focusing on migrant rescue specifically, this Article makes three contributions. First, it argues that the law of rescue generally privileges property …

Healthcare Licensing And Liability, Benjamin J. Mcmichael

Articles

The United States' affordable care crisis and chronic physician shortage have required advanced practice registered nurses "APRNs" and physician assistants "PAs" to assume increasingly important roles in the healthcare system The increased use of these nonphysician providers has improved access to healthcare and lowered the price of care However restrictive occupational licensing laws"”specifically scopeofpractice laws"”have limited their ability to care for patients While these laws by themselves have important implications for the healthcare system they also interact with other legal regimes to impact the provision of care Restrictive scopeofpractice laws can increase the malpractice liability risk of physicians and decrease …

Zoom Wills, Alberto Lopez

Articles

This brief essay suggests that suddenly popular online meeting platforms like Zoom can be used to execute wills while people are subject to shelterin-place orders following the outbreak of the COVID-19 pandemic. Although will execution ceremonies using Zoom do not strictly comply with statutory formalities, Zoom-based ceremonies satisfy the two primary curative doctrines-the substantial compliance doctrine and the UPC's harmless error rule-for admission to probate. Informed by statutes that recognize e-wills, the essay concludes that a Zoom-based execution ceremony produces a Zoom will without stretching statutory formalities beyond recognition during a period of extreme isolation.

Performing The Digital Self: Understanding Location-Based Social Networking, Territory, Space, And Identity In The City, Konstantinos Papangelis, Alan Chamberlain, Ioanna Lykourentzou, Vassilis-Javed Khan, Michael Saker, Hai-Ning Liang, Irwyn Sadien, Ting Cao

Articles

Expressions of territoriality have been positioned as one of the main reasons users alter their behaviors and perceptions of spatiality and sociality while engaging with location-based social networks (LBSN). Despite the potential for this interplay to further our understanding of LBSN usage in the context of identity, very little work has actually been done towards this. Addressing this gap in the literature is one the chief aims of the article. Drawing on an original six-week study with 42 participants utilizing a bespoke LBSN entitled ‘GeoMoments’, our research explores: (1) the way that territoriality is linked to self-identity; and (2) how …

Acts Of Meaning, Resource Diagrams, And Essential Learning Behaviors: The Design Evolution Of Lost & Found, Owen Gottlieb, Ian Schreiber

Articles

Lost & Found is a tabletop-to-mobile game series designed for teaching medieval religious legal systems. The long-term goals of the project are to change the discourse around religious laws, such as foregrounding the prosocial aspects of religious law such as collaboration, cooperation, and communal sustainability. This design case focuses on the evolution of the design of the mechanics and core systems in the first two tabletop games in the series, informed by over three and a half years’ worth of design notes, playable prototypes, outside design consultations, internal design reviews, playtests, and interviews.

Taming Conflicting Identities: Searching For New Youth Values In The Western Balkans, Vladimir Turjacanin, Iris Zezelj, Edona Maloku, Marija Brankovic

Articles

In the post-conflict societies of the Western Balkans (Serbia, Kosovo, Bosnia and Herzegovina and Macedonia) ethnic and religious identities continue to constitute a major source of tension. Knowing that the youth tend to be the bearer of the future societal values, we aimed to explore if young people in this region are able to construct their identities in a more inclusive way and overcome these divisive group identifications. We conducted a survey among 767 people aged 20 to 30, from Belgrade, Novi Pazar, Prishtina, North Mitrovica, Banja Luka, Sarajevo, Skopje and Tetovo. In each country, we selected one town with …

Genome-Wide Dna Methylation Meta-Analysis In The Brains Of Suicide Completers, Stefania Policicchio, Sam Washer, Joana Viana, Artemis Iatrou, Joe Burrage, Eilis Hannon, Gustavo Tureki, Zachary Kaminsky, Jonathan Mill, Emma L. Dempster, Therese Murphy

Articles

Suicide is the second leading cause of death globally among young people representing a significant global health burden. Although the molecular correlates of suicide remains poorly understood, it has been hypothesised that epigenomic processes may play a role. The objective of this study was to identify suicide-associated DNA methylation changes in the human brain by utilising previously published and unpublished methylomic datasets. We analysed prefrontal cortex (PFC, n = 211) and cerebellum (CER, n = 114) DNA methylation profiles from suicide completers and non-psychiatric, sudden-death controls, meta-analysing data from independent cohorts for each brain region separately. We report evidence for …

Cu(Ii) Phenanthroline-Phenazine Complexes Dysregulate Mitochondrial Function And Stimulate Apoptosis, Garret Rochford, Zara Molphy, Kevin Kavanagh, Malachy Mccann, Michael Devereux, Andrew Kellett, Orla L. Howe

Articles

Herein we report an in-depth study on the cytotoxic mechanism of action of four developmental cytotoxic copper(II) complexes: [Cu(phen)2]2+ (Cu-Phen); [Cu(DPQ)(Phen)]2+ (Cu-DPQ-Phen); [Cu(DPPZ)(Phen)]2+; and [Cu(DPPN)(Phen)]2+ (where Phen = 1,10-phenanthroline, DPQ = dipyrido[3,2-f:20,30-h]quinoxaline, DPPZ = dipyrido[3,2-a:20,30-c]phenazine, and DPPN = benzo[i]dipyrido[3,2-a:20,30-c]phenazine). This complex class is known for its DNA intercalative properties and recent evidence—derived from an in vivo proteomic study—supports the potential targeting of mitochondrial function. Therefore, we focused on mitochondrial-mediated apoptosis related to cytotoxic activity and the potential impact these agents have on mitochondrial function. The Cu(II) complexes demonstrated superior activity regardless of aromatic extension within the phenazine ligand to the …

I Was Determined To Breastfeed, And I Always Found A Solution: Successful Experiences Of Exclusive Breastfeeding Among Chinese Mothers In Ireland, John Kearney, Qianling Zhou, Haoyue Chen, Katherine Younger, Tanya M. Cassidy

Articles

Background: The prevalence of exclusive breastfeeding for at least 4 months was previously found to be very low among Chinese immigrants in Ireland, at 5.8% (Zhou et al., Front Public Health 6:351, 2018). This study investigates the successful experiences of Chinese mothers living in Ireland who exclusively breastfeed for between four and 6 months.

Methods: Participants were recruited from the sample of the Ireland Chinese Mother Survey. Qualitative in-depth interviews were conducted with fourteen participants in their homes or public places.

Results: A content analysis revealed that various factors contributed to a successful experience of exclusive breastfeeding among the group …

Forscells: 40-Days Fixed Prepared Reagent For Detection Of Anti-Forssman Inhumans, Sofia Ferreira, Cristiana Mourato, Alyssa Corpuz, Sofia Galvão, Camilla Hesse, Clara Rocha, Carlos Jesus, Fernando Mendes

Articles

In 2012, the FORS system was accepted by the International Society of Blood Transfusion as the 31^st blood group system. Forssman (Fs) antigen (Ag) expression is most commonly found on sheep red blood cells (RBC) but rare in human RBC. Anti-Fs antibodies (Ab) are naturally occurring in human sera and are predominantly IgM but they can also be IgG. To this day, the global prevalence of the FORS system is unknown. Currently, there is a lack of natural FORS1-positive RBC available to use for anti-Fs screening in large populations. This study was designed to produce FORS1-positive cells viable for …

Preoperative Exercise To Improve Fitness In Patients Undergoing Complex Surgery For Cancer Of The Lung Or Oesophagus (Pre-Hiit): Protocol For A Randomized Controlled Trial, Grainne Sheill, Emer Guinan, Linda O'Neill, Charles Normand, Suzanne Doyle, Sarah Moore, John Newell, Granne Mcdermott, Ronan Ryan, John V. Reynolds, Juliette Hussey

Articles

Patients with cancer of the lung or oesophagus, undergoing curative treatment, usually require a thoracotomy and a complex oncological resection. These surgeries carry a risk of major morbidity and mortality, and risk assessment, preoperative optimisation, and enhanced recovery after surgery (ERAS) pathways are modern approaches to optimise outcomes. Pre-operative fitness is an established predictor of postoperative outcome, accordingly, targeting pre-operative fitness through exercise prehabilitation has logical appeal. Exercise prehabilitation is challenging to implement however due to the short opportunity for intervention between diagnosis and surgery. Therefore, individually prescribed, intensive exercise training protocols which convey clinically meaningful improvements in cardiopulmonary fitness …

Microfluidics In Haemostasis: A Review, Heta Jigar Panchal, Nigel Kent, Andrew Knox, Leanne Harris

Articles

Haemostatic disorders are both complex and costly in relation to both their treatment and subsequent management. As leading causes of mortality worldwide, there is an ever-increasing drive to improve the diagnosis and prevention of haemostatic disorders. The field of microfluidic and Lab on a Chip (LOC) technologies is rapidly advancing and the important role of miniaturised diagnostics is becoming more evident in the healthcare system, with particular importance in near patient testing (NPT) and point of care (POC) settings. Microfluidic technologies present innovative solutions to diagnostic and clinical challenges which have the knock-on effect of improving health care and quality …

Vibrational Spectroscopy Of Liquid Biopsies For Prostate Cancer Diagnosis, Dinesh Medipally, Daniel Cullen, Valérie Untereiner, G.D. Sockalingum, Adrian Maguire, T.N.Q. Nguyen, Jane Bryant, Emma Noone, Shirley Bradshaw, Marie Finn, Mary Dunne, Aoife M. Shannon, John Armstrong, Aidan Meade, Fiona Lyng

Articles

Background: Screening for prostate cancer with prostate specific antigen and digital rectal examination allows early diagnosis of prostate malignancy but has been associated with poor sensitivity and specificity. There is also a considerable risk of over-diagnosis and overtreatment, which highlights the need for better tools for diagnosis of prostate cancer. This study investigates the potential of high throughput Raman and Fourier Transform Infrared (FTIR) spectroscopy of liquid biopsies for rapid and accurate diagnosis of prostate cancer.

Methods: Blood samples (plasma and lymphocytes) were obtained from healthy control subjects and prostate cancer patients. FTIR and Raman spectra were recorded from plasma …

A Novel Pool Of Microparticle Cholesterol Is Elevatedin Rheumatoid Arthritis But Not In Systemic Lupus Erythematosus Patients, Shuai Shuai Hu, Brenton L. Cavanagh, Robert Harrington, Muddassar Ahmad, Grainne Kearns, Steve Meaney, Claire Wynne

Articles

Microparticles are sub-micron, membrane-bound particles released from virtually allcells and which are present in the circulation. In several autoimmune disorders their amountand composition in the circulation is altered. Microparticle surface protein expression has beenexplored as a differentiating tool in autoimmune disorders where the clinical pictures can overlap.Here, we examine the utility of a novel lipid-based marker—microparticle cholesterol, present in allmicroparticles regardless of cellular origin—to distinguish between rheumatoid arthritis (RA) andsystemic lupus erythematosus (SLE). We first isolated a series of microparticle containing lipoproteindeficient fractions from patient and control plasma. There were no significant differences in thesize, structure or protein content of …

Adherence To Dietary And Physical Activity Guidelines Among Shift Workers: Associations With Individual And Work-Related Factors, Ciara Kelly, Fiona M. Nea, Kirsty Pourshahidi, John Kearney, Victoria M O'Brien, M Barbara E Livingstone, Clare Corish

Articles

Objectives Shift work is associated with adverse effects on the health and lifestyle behaviours of employees. This study aimed to examine factors associated with adherence among shift workers to selected indicators of dietary and physical activity guidelines. Methods A cross-sectional study was conducted on 1300 shift workers. Data were collected using a 15 minute telephone-administered questionnaire. Logistic regression methods were used for data analysis. Results Male shift workers (p