bluuebunny/crossref_metadata_2025_split huggingface dataset:
Lean Stability Approaches in Pharmaceutical Product Development, Registration, and Post-marketing CMC Change Management; Industry Survey Insights
Authors: Pulliam Donnie , McMahon Megan , Regler Brian P. , Smith Susan , Martin Cheryl , Babayan Yelizaveta , Hoaglund-Hyzer Cherokee , Lesslie Michael , Qiu Fenghe , Adamec Eric , Wang Jin , Forenzo Pat , Wannere Chaitanya S. , Zhuang Ping , Gruenig Lars 
Published: June 2021

Abstract
Purpose
This paper summarizes results from a recent pharmaceutical industry survey to understand the adoption status of science- and risk-based approaches in pharmaceutical stability (lean stability) in regulatory submissions across the full pharmaceutical product life cycle and to ascertain whether companies are deriving their stability strategies based on scientific risk or applying generic strategies.

Methods
A comprehensive survey was distributed to pharmaceutical companies affiliated with the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) to solicit non-proprietary responses pertaining to regulatory strategies for stability monitoring across the product life cycle, perceived risks, and health authority feedback.

Results
Among the 19 responding companies, utilization of lean stability approaches varied with respect to (1) phase of product life cycle, (2) specific product quality attributes cited in effective ICH guidances or which demonstrated shelf-life limiting stability trends, and (3) the degree of perceived risk of rejection by health authorities based upon companies’ degree of experience from previous regulatory submissions.

Conclusion
Continued collaboration between the pharmaceutical industry and health authorities—through case studies and revision/harmonization of regulatory guidances—will be essential for continued implementation of lean stability strategies to accelerate delivery of innovative medicines to the clinic and to the market.
Effects of fungal inoculation on the growth of Salicornia (Amaranthaceae) under different salinity conditions
Authors: Gonçalves Danilo Reis , Pena Rodica , Zotz Gerhard , Albach Dirk C. 
Published: June 2021

AbstractEndophytic fungi are known to be present in roots of salt marsh plants, but their ecological role in this symbiosis is still largely unknown. Generally considered parasitic or saprophytic, they may still be mutualistic, at least under certain circumstances. Among salt marsh plants,Salicorniaspp. are recognized as particularly salt-tolerant and their frequent colonization by root endophytes has also been reported. This study aimed to investigate whether the inoculation ofSalicorniawith different root endophytes isolated from field-collectedSalicorniaaffects biomass production, nutrient uptake and photosynthesis (assessed via chlorophyll fluorescence). In addition, we investigated whether fungal inoculation confers tolerance to salt stress given that endophytes are suggested to increase salt tolerance and improve plant fitness in other less salt-tolerant plants. The inoculation ofSalicorniawith an isolate of the genusStemphyliumpositively influenced total biomass production and nitrogen concentration in roots at optimum salinity condition (150 mM NaCl). However, under salt stress (650 mM NaCl), no significant effects of fungal inoculation on biomass production and photosynthesis were observed. Further, positive and negative effects of fungal inoculation on nutrient concentrations were observed in roots and shoots, respectively. Our results indicate that different endophytic fungi and their interaction result in distinct fungal species-specific plant growth responses ofSalicorniaunder different growth conditions.
A technique to identify the predominant pore direction in a porous medium and application to reservoir rocks
Authors: Roque Waldir L. , Neto Edvaldo F. M. , Cruz Júnior José V. P. 
Published: June 2021

AbstractThe study of the pore space structure of a porous medium has been very much improved with the aid of microtomographic imaging and its analysis through image processing. In this paper, a technique to identify the predominant pore direction (PPD) in the pore space is introduced and according to that the pore space can be partition as vertical (V), horizontal (H) or diagonal (D). The PPD technique has been developed for 2D and 3D spaces based on microCT images of a porous medium and can be used to both, pore or grain spaces. An implementation of the PPD has been done in an in-house computer program using Phyton. A set of application tests for 2D and 3D PPD partitioning is given, being, respectively, i) a synthetic binary image and a binary image of a Berea sandstone rock sample and ii) a Berea sandstone and a Carbonate reservoir rock core samples, both provided by the MicroCT Images and Networks of Imperial College London database, and a 3D grain partitioning of a trabecular bone structure. Additionally, the V, H and D PPD effective pore networks of a pore space are determined; the porosities for the PPD subspaces and for their effective pore networks are computed and results are provided. Finally, a brief discussion about the implementation and computational cost for the 2D and 3D cases is provided. It is worth to mention that the findings of this study may help for better understanding of directional fluid flow and mechanical stress in porous medium.
Adsorption of malic acid at the hydroxyapatite/aqueous NaCl solution interface
Authors: Janusz Władysław , Skwarek Ewa 
Published: June 2021

AbstractThe aim of the study was the basic incidence on the phenomenon of adsorption that occurs at the hydroxyapatite/malic acid interface, leading to a change in the surface properties of hydroxyapatite, Analytical methods used in the research: X-ray diffraction (XRD) as well as by the, adsorption–desorption of nitrogen (ASAP), potentiometric titration. The specific adsorption of malic acid ions at the hydroxyapatite interface was investigated by means of the radioisotope method. The zeta potential of hydroxyapatite dispersions was determined by electrophoresis with Zetasizer Nano ZS90 by Malvern. The particle sizes of hydroxyapatite samples were analyzed using Masteriszer 2000 Malvern. Studies on the kinetics of malic acid on hydroxyapatite from a solution with an initial concentration of 1 mmol/dm3 have shown that the adsorption process is initially fast, followed by a slow adsorption step. An increase in the pH of the solution causes a decrease in the malic acid adsorption as a result of competition with hydroxyl ions. The presence of adsorbed malic acid was confirmed by the FTIR measurements. The effect of malic acid adsorption on the zeta potential and particle size distribution of hydroxyapatite in the NaCl solution was investigated.
Pure and Sb-doped ZrO2 for removal of IO3− from radioactive waste solutions
Authors: Suorsa V. , Otaki M. , Virkanen J. , Koivula R. 
Published: June 2021

AbstractRadioactive 129I with a long half-life (1.57 × 107 y) and high mobility is a serious radiohazard and one of the top risk radionuclides associated with its accidental and planned releases to nature. The complex speciation chemistry of iodine makes its removal a complicated task, and usually a single method is not able to remove all iodine species. Especially its oxidized form iodate (IO3−) lacks a selective and effective removal method. Here, the granular aggregates of hydrous zirconium oxides with and without antimony doping were tested for IO3− removal and the effects of contact time, competing anions in different concentrations and pH were examined. The materials showed high selectivity for IO3− (Kd over up to 50,000 ml/g) in the presence of competing ions and relatively fast uptake kinetics (eq. < 1 h). However, B(OH)4− and SO42−, as competing ions, lowered the iodate uptake significantly in basic and acidic solution, respectively. The suitability of the materials for practical applications was tested in a series of column experiments where the materials showed remarkably high apparent capacity for the IO3− uptake (3.2–3.5 mmol/g).
Graphic abstract
Familie und Schule in der Adoleszenz: Ergebnisse qualitativer Längsschnittuntersuchungen zu Bewährungsanforderungen von der Grundschule bis zum Übergang in die Ausbildung bzw. das Studium
Authors: Silkenbeumer Mirja , Thiersch Sven 
Published: June 2021

ZusammenfassungDer Beitrag stützt sich auf Erkenntnisse aus drei qualitativen Längsschnittstudien, in denen Heranwachsende und ihre Familien in relevanten Phasen der Schullaufbahn befragt und Bildungsverläufe aus subjekttheoretischer Sicht analysiert worden sind. Auf der Grundlage der übergreifenden Befunde dieser Untersuchungen wird argumentiert, dass sich Jugendliche in schulischen Bildungsverläufen, unabhängig davon, wie erfolgreich diese vollzogen werden und in welche sozialen Strukturen sie eingebettet sind, als Subjekte bewähren müssen. Sie sind in der Adoleszenz damit konfrontiert, sich gegenüber schulischen Anforderungen und bildungsbezogenen Delegationen in ihren Familien zu positionieren und den Bildungsverlauf in das werdende Selbst zu integrieren. Diese kaum erforschten und diskutierten subjektiven Modi, Bewährungsanforderungen zu gestalten, sind mit Selbst- und Fremdzuschreibungen im Kontext beziehungsdynamischer, intergenerational strukturierter Ablösungs- und Individuationsprozesse in Familie und Schule verbunden. Im Beitrag werden unterschiedliche adoleszente Bewährungsformen im Zusammenspiel von Familie und Schule typologisch ausgeleuchtet. Vor diesem Hintergrund differenzieren wir die bisherigen Erkenntnisse der Schul- und Bildungsforschung zur sozialen Hervorbringung schulbezogener Haltungen sowie zu Verläufen und Übergängen von Jugendlichen im Bildungssystem.
Quantitative evaluation of augmented strain at the weld metal during the Trans-Varestraint test
Authors: Yamashita Shotaro , Okano Shigetaka , Mochizuki Masahito , Saida Kazuyoshi 
Published: June 2021

AbstractThe hot cracking susceptibility in the Trans-Varestraint test was evaluated using the nominal strain calculated using the curvature radius of a bending block and the thickness of a specimen based on the theory of material mechanics. The nominal strain was calculated using the material properties at room temperature. Thus, in the Trans-Varestraint test, the non-uniformity of the strain around the weld part due to the temperature distribution is not considered. Therefore, the strain in the Trans-Varestraint test cannot be evaluated correctly. The aim of this study is to reveal the loaded strain at the weld metal to understand the evaluation of hot cracking susceptibility in the Trans-Varestraint test. The loaded strain around the trailing edge of the weld pool of pure iron was measured in-situ using a high-speed camera and high-resolution optical lens. The results of strains measured using image analysis and the finite-element method at the center of the weld bead were compared. Accordingly, it was clarified that the strain was concentrated on the weld part owing to the bending occurring along the weld line, and the strain exceeding the nominal strain was loaded to the trailing edge of the weld pool.
Shared Cultural Values Influence Mental Health Help-Seeking Behaviors in Asian and Latinx College Students
Authors: Zhou E. , Kyeong Y. , Cheung C. S. , Michalska K. J. 
Published: June 2021

AbstractThe current study sought to understand the influence of cultural values on mental health attitudes and help-seeking behaviors in college students of diverse ethnic backgrounds. Asian and Latinx college students (N = 159) completed an online survey in which they reported on their adherence to cultural values as measured by ethnicity-specific cultural values and general attitudes towards mental health. Factor analysis revealed two common factors of cultural values irrespective of ethnicity: Interdependent Orientation (IO) and Cultural Obligation (CO). Regardless of ethnicity, the more students endorsed IO values, the less likely they were to perceive a need for mental health treatment. IO value adherence was also predictive of more negative attitudes towards mental health. CO values were not predictive of perceived need or help-seeking behaviors. Findings highlight the importance of understanding shared cultural values across ethnic-racial groups and considering how the multidimensionality of culture may help explain shared mental health behaviors crossing lines of ethnic group membership.
An infrastructure-assisted job scheduling and task coordination in volunteer computing-based VANET
Authors: Waheed Abdul , Shah Munam Ali , Khan Abid , Jeon Gwanggil 
Published: June 2021

AbstractVehicular networks as the key enablers in Intelligent Transportation Systems (ITS) and the Internet of Things (IoT) are key components of smart sustainable cities. Vehicles as a significant component of smart cities have emerging in-vehicle applications that can assist in good governance for sustainable smart cities. Most of these applications are delay sensitive and demand high computational capabilities that are provided by emerging technologies. Utilizing the distributed computational resources of vehicles with the help of volunteer computing is an efficient method to fulfill the high computational requirements of vehicles itself and the other components of smart cities. Vehicle as a resource is an emerging concept that must be considered to address the future challenges of sustainable smart cities. In this paper, an infrastructure-assisted job scheduling and task coordination mechanism in volunteer computing-based VANET called RSU-based VCBV is proposed, which enhances the architecture of VANET to utilize the surplus resources of vehicles for task execution. We propose job scheduling and task coordination algorithms for different volunteer models. Further, we design and implement an adaptive task replication method to seek fault tolerance by avoiding task failures due to locations of vehicles. We propose a task replication algorithm called location-based task replication algorithm. Extensive simulations validate the performance of our proposed volunteer models while comparing average task execution time and weight ratios with existing work.
Arbeits- und Gesundheitsschutz im Rahmen der Arbeitnehmerentsendung
Authors: Kohte Wolfhard 
Published: June 2021

ZusammenfassungEntsendung führt zu Problemen im Arbeits- und Gesundheitsschutz, weil die Bildung betrieblicher Sonderwelten, die oft sprachlich und kulturell abgeschieden sind, Defizite gegenüber der allgemeinen betrieblichen Arbeitsschutzpolitik hervorrufen. Die bisherigen Untersuchungen haben gezeigt, dass sich dadurch verstärkt Unfälle und Gesundheitsprobleme bei entsandten Beschäftigten ergeben.
Die Europäische Union hat 1996 mit der Entsenderichtlinie die Mitgliedsstaaten in für Pflicht genommen, dass sie für entsandte Beschäftigte die Sicherung der Arbeitszeit- und Arbeitsschutzvorschriften gewährleisten. Diese Pflicht ist in Deutschland in § 2 AEntG normiert worden, jedoch fehlt bis heute die gebotene Umsetzung. Die Arbeitsschutzbehörden erhalten nicht die erforderlichen Informationen, so dass auch eine gezielte Überwachung bisher nicht stattfindet. Die Information der entsandten Beschäftigten in ihrer eigenen Sprache ist weiterhin unzureichend. Angesichts dieser Situation legt ein erster Schwerpunkt der Arbeitsschutzpolitik in einer besseren Verpflichtung der deutschen Auftraggeber, die bereits im Baustellenrecht und der Fleischwirtschaft verwirklicht worden ist. Weitere Verbesserungen können durch eine effektive Umsetzung von Kooperationspflichten (§ 8 ArbSchG) sowie auf dem zivilgesellschaftlichen Weg durch Beratungsstellen und die Arbeit der Betriebsräte und Gewerkschaften erfolgen.
The COVID-19 Pandemic from the Health Workers’ Perspective: Between Health Emergency and Personal Crisis
Authors: Marinaci Tiziana , Venuleo Claudia , Savarese Giulia 
Published: June 2021

AbstractDifferent scholars have emphasised the psychological distress experienced by health workers during the COVID-19 pandemic; however, there are almost no qualitative studies and we know very little about the everyday experience of this group. The present study’s goal was to explore how health workers interpreted the meaning of the pandemic crisis in their life. An online survey was available during the Italian lockdown. Respondents were asked to write a passage about the meaning of living in the time of COVID-19. A total number of 130 questionnaires (M = 42.35; DS = 10.52; women: 56.2%) were collected. The Automated Method for Content Analysis (ACASM) procedure was applied to the collected texts to detect the factorial dimensions underpinning (dis)similarities in the respondents’ narratives. Such factors were interpreted as the markers of latent dimensions of meanings (DS). The two main DS that emerged were characterised by the pertinentisation of two extremely basic issues: what the pandemic represents (health emergency versus personal crisis) and its impact (powerlessness versus discovery of new meanings). On the whole, health workers’ narratives help to highlight the risk of normalising the feelings of fear and impotence experienced when facing the health emergency and the need to recognise that such feelings are strictly intertwined with the limited resources received to “face the battle”; the need to recognize the human vulnerability of the women and men “inside the lab coat” and the human effort to maintain or reconstruct a sense of self and purpose in the face of troubled circumstances.
3D FEM Model on the Parameters’ Influence of EPB-TBM on Settlements of Single and Twin Metro Tunnels During Construction
Authors: Forsat Masoud , Taghipoor Mohammad , Palassi Masoud 
Published: June 2021

AbstractThe present research exposes the investigation on three-dimensional modeling of the single and twin metro tunnels for the case of the Tehran metro line. At first, simulation implemented on the comparison of the ground movements in the single and twin tunnels. Then the simulation has been performed on the influence of effective parameters of EPB-TBM on the surface settlements throughout excavation. The overcutting, shield conicity, grouting, and the final lining system modeled and the influence of face supporting pressure, grout injection pressure, as well as the clear distance of the tunnels, has been analyzed. The initial results showed a valid ground settlement behavior. The maximum settlements occurred at the end of the shield tail and it was higher in the single tunnel. The face supporting pressure had more effect on the surface settlement in comparison to the grout injection pressure. By increasing the face pressure in the single tunnel, the place of maximum settlement moved back while the grout pressure is insignificant for decreasing the settlements. Furthermore, the influence of the clear distance in the twin tunnels led to zero after the length of 30 m. Accordingly, for more distances, the tunnels must be examined independently and as two different single tunnels.
Epidemiology of Eastern Massasauga (Sistrurus catenatus) Snakebites in the Great Lakes States, 1800–2015
Authors: Wasko Dennis K. , Bullard Stephan G. , Beauvais Thomas F. 
Published: June 2021

Introduction The eastern massasauga rattlesnake ( Sistrurus catenatus) has the northernmost distribution of any venomous snake in the United States and presents a potential, but little-studied, risk to humans. Methods We quantified the reported incidence of massasauga bites to humans in the Great Lakes states by searching historic and contemporary media reports between 1800 and 2015. Results We identified 848 reported massasauga bites across the region, most of which were concentrated along the border of Indiana and Michigan. The number of bites per decade increased into the late 1800s as human population increased; it then declined sharply in the 1900s, likely owing to declining massasauga population and habitat. The majority of bites were to adult males. There was no relationship between victim sex and age or activity when bitten. Most bites resulted from snakes the victims were unaware of, usually when individuals accidentally put their hands or feet near an unseen snake. Many bites, however, resulted from people intentionally interacting with a massasauga, such as attempting to capture or kill it. Fatality rates were lower among men than among women and were lower in adolescents than older or younger victims. No fatalities from massasaugas were reported after 1935. Conclusions Fatality rates from massasauga bites reported herein should be interpreted with caution owing to the nature of the data we collected. In the modern era, massasauga bites are generally considered neither common nor life-threatening, although our findings suggest that historically they may have been both more frequent and potentially more dangerous.
Differentiating Sources of Fecal Contamination to Wilderness Waters Using Droplet Digital PCR and Fecal Indicator Bacteria Methods
Authors: Pendergraph Daniel P. , Ranieri John , Ermatinger Lochlin , Baumann Adam , Metcalf Alexander L. , DeLuca Thomas H. , Church Matthew J. 
Published: June 2021

Introduction Human activity in wilderness areas has the potential to affect aquatic ecosystems, including through the introduction of microorganisms associated with fecal contamination. We examined fecal microorganism contamination in water sources (lake outlets, snowmelt streams) in the popular Absaroka Beartooth Wilderness in the United States. Although the region is remote, increasing human visitation has the potential to negatively affect water quality, with particular concern about human-derived microorganism fecal contaminants. Methods We used standard fecal indicator bacterial assays that quantified total coliform bacteria and Escherichia coli concentrations, together with more specific polymerase chain reaction-based microbial assays that identified possible human sources of fecal microorganisms in these waters. Results Total coliforms were detected at all lake outlets (21 of 21 sites), and E coli was detected at 11 of 21 sites. Droplet digital polymerase chain reaction assays revealed the presence of human feces-derived microorganisms, albeit at abundances below the limit of detection (<10 gene copies per milliliter of water) at all but 1 of the sampling sites. Conclusions Our results suggest low prevalence of water-borne pathogens (specifically E coli and human-derived Bacteroides) in this popular wilderness area. However, widespread detection of total coliforms, Bacteroides, and E coli highlight the importance of purifying water sources in wilderness areas before consumption. Specific sources of total coliforms and E coli in these waters remain unknown but could derive from wild or domesticated animals that inhabit or visit the Absaroka Beartooth Wilderness. Hence, although contamination by human fecal microorganisms appears minimal, human visitation could indirectly influence fecal contamination through domesticated animals.
Does single pregnancy hurt birth outcomes among young mothers?
Authors: Kim Young-Il , Lee Jungmin 
Published: June 2021

AbstractDoes single pregnancy adversely affect infant health? This is a challenging research question because there is selection in coresidence during pregnancy. We exploit quasi-natural variation in single pregnancy from the moment of conception to birth, arising from the reform of the marriageable age laws in Korea. The Korean birth certificate data are unique. They provide the information about the coresidence status in addition to the legal marital status. The coresidence start date allows us to identify the intensity of coresidence during pregnancy. We find that coresidence or legal marriage during pregnancy does not significantly affect birth outcomes.