bluuebunny/crossref_metadata_2025_split huggingface dataset:
Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe
Authors: Makwana Rajdeep G. , Desai Kuldeep V. , Kikani Vaibhav , Vaja Maulikkumar D. 
Published: July 2021

Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company. It is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines, healthcare products to individuals around the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Today 35 member countries along with 11 candidate countries and 4 international agencies have joined together to create the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to promote a globally accepted GMP. Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO).
Mineralogical, Microstructural and Compressive Strength Characterization of Fly Ash as Materials in Geopolymer Cement
Authors: Rahmawati Cut , Aprilia Sri , Saidi Taufiq , Aulia Teuku Budi 
Published: July 2021

Abstract: This study was designed to examine the mineral, microstructural, and mechanical strength properties of fly ash and its feasibility as a raw material for geopolymer cement. The study used an experimental method by examining the characteristics of fly ash by X-ray Fluorescence Spectrometer (XRF), Fourier transform infrared (FTIR) spectroscopy, X-ray diffraction (XRD), hydrometer method, Scanning electron microscopy (SEM), and compressive strength testing. For creating the geopolymer cement paste, a concentration of NaOH 10M was used, with a ratio of water/solid = 0.4 and a ratio of Na2SiO3/NaOH = 1 using curring at room temperature. The results showed the geopolymer pastes have a compressive strength of 18.1 MPa and 21.5 MPa after 7 days and 28 days. The XRD results showed a decrease in the peak of 2θ at 26.54° because the amorphous part had transformed into a C-S-H solution in geopolymer cement. This finding was supported by the FTIR spectra results showing Si-O-Si bending vibration and the functional group of AlO2. It showed that Nagan Raya fly ash-based geopolymer is a potential construction material.Abstrak: Penelitian ini dirancang untuk mendapatkan sifat mineral, mikrostruktural, dan kekuatan mekanis dari fly ash serta kesesuaiannya sebagai material dasar pada semen geopolimer. Metode penelitian yang digunakan adalah metode eksperimen dengan cara menguji karakteristik dari fly ash dengan pengujian X-ray Fluorescense Spectrometer (XRF), Fourier transform infrared (FTIR) spectoscopy, X-ray diffraction (XRD), hydrometer method, Scanning electron microscopy (SEM) dan kuat tekan. Untuk pembuatan pasta semen geopolimer digunakan konsentrasi NaOH 10 M, rasio water/solid 0,4 dan rasio Na2SiO3/NaOH = 1 dengan perawatan pada suhu kamar. Hasil menunjukkan setelah 7 hari pasta geopolimer memiliki kuat tekan 18,1 MPa dan 21,5 MPa pada 28 hari. Hasil XRD menunjukkan adanya penurunan puncak 2θ pada 26,54° ini disebabkan karena bagian amorf dari fly ash telah menjadi larutan C-S-H pada semen geopolimer. Hasil ini diperkuat dengan analisis FTIR spectra yang menunjukkan adanya Si-O-Si bending vibration dan gugus fungsi dari AlO2. Hasil menunjukkan fly ash dari Nagan Raya potensial sebagai bahan material konstruksi berbasis geopolimer.
Keamanan Individu (Personal Security) dan Qanun Hukum Keluarga: Tinjauan Konsep Keamanan Manusia (Human Security)
Authors: Mumtazinur Mumtazinur , Sri Wahyuni Yenny 
Published: July 2021

Wacana qanun hukum keluarga di Aceh yang muncul pada pertengahan tahun 2019 sedikit banyak wacana formalisasi qanun ini menyita perhatian masyarakat baik lokal maupun nasional. Kehadiran qanun hukum keluarga ini juga menimbulkan pro dan kontra di kalangan masyarakat dengan argumentasi masing-masing. Tulisan ini mencoba menelaah perihal formalisasi qanun hukum keluarga dari perspektif keamanan manusia (human security) yang berfokus pada keamanan individu (Personal Security). Latar belakang yang melandasi pembentukan qanun hukum keluarga ini adalah dalam rangka upaya untuk membentuk Qanun Aceh tentang Hukum Keluarga (Ahwal Al-Syakhshiyah) yang mampu mengatur, membina, menjamin hak-hak dan menyelesaikan berbagai persoalan keluarga secara komprehensif di tengah-tengah masyarakat Aceh. Perspektif keamanan manusia (human security) melihat regulasi ini sebagai bagian dari upaya mewujudkan keamanan personal (personal security) ditingkat lokal yang sejalan dengan agenda utama keamanan manusia. Lebih lanjut sinergitas ini sesuai dengan kerangka kerja HS yaitu adanya tindakan terintegrasi di antara jaringan pemangku kepentingan (From coordination to integration, Mensinergikan berbagai aktor penting seperti pemerintah, masyarakat sipil, komunitas lokal, dan lain sebagainya (Promoting multi-stakeholder partnerships), Menemukan akar penyebab (Localisation and „leaving no one behind‟), dan tindakan pencegahan serta memperkuat ketahanan (Prevention and resilience).
Hadis pada Masa Rasulullah dan Sahabat: Studi Kritis terhadap Pemeliharaan Hadis
Authors: Usman Iskandar 
Published: July 2021

Hadis adalah ucapan, perbuatan, dan perngakuan/persetujuan yang disandarkan kepada Rasulullah SAW. Hadis merupakan sumber ajaran Islam yang kedua. Hadis dalam hubungannya dengan sumber ajaran Islam yang pertama, Alquran, berfungsi menjelaskan (memperjelas isi/kandungan) Alquran, menguatkan hukum-hukum (yang ditetapkan) Alquran, dan menetapkan beberapa hukum yang tidak dijelaskan (dalam) Alquran. Ada dua hadis yang kontradiktif mengenai penulisan hadis, hadis yang melarang dan hadis yang menganjurkan penulisan hadis. Makalah ini ingin mengkaji secara kritis bagaimana sesungguhnya masalah penulisan hadis pada masa Rasulullah dan sahabat, bagaimana mengkompromikan kedua hadis tersebut dengan pendekatan Ilmu Mukhtalif Hadis dan pendekatan historis mengenai fakta yang terjadi pada masa Rasulullah dan sahabat, juga ingin mengkaji mengapa setelah wafatnya Rasululullah para sahabat membatasi periwayatan hadis.
Taken for Suckers: Causal Attributions of the Consequences of Overcharging Sales Tax in Daily Deal Transactions
Authors: Foy Joseph , Sampath Vijay S. , Raskin Rachel , Kass-Shraibman Frimette , Gopalakrishna Pradeep 
Published: July 2021

ABSTRACT
In an experimental setting, we examine consumer reactions in daily deal transactions when they are overcharged sales tax. Overcharges arise when the daily deal operators subsequently provide additional discounts to consumers unbeknownst to the merchants. Drawing on social status and attribution theories, we posit that consumers will ascribe causes for the overcharges to the merchants because of their lower status when compared to the higher status of the daily deal operators. We then examine the main and moderating effects of the overcharges on the behavioral intentions of consumers to repurchase from merchants. Merchants' ability to verify correct sales prices, descriptive social norms, and the trust placed in accountants explain variations in repurchase intentions. Overall, the results suggest that ethical norm violations by higher-status entities results in the transfer of negative consequences to lower-status entities. Forensic accountants can be instrumental in helping businesses to understand the effects of ethical norm violations.
Pre-derivations and description of non-strongly nilpotent filiform Leibniz algebras
Authors: Abdurasulov K.K. , Khudoyberdiyev A. Kh. , Ladra M. , Sattarov A.M. 
Published: July 2021

Abstract
In this paper we give the description of some non-strongly nilpotent Leibniz algebras. We pay our attention to the subclass of nilpotent Leibniz algebras, which is called filiform. Note that the set of filiform Leibniz algebras of fixed dimension can be decomposed into three disjoint families. We describe the pre-derivations of filiform Leibniz algebras for the first and second families and determine those algebras in the first two classes of filiform Leibniz algebras that are non-strongly nilpotent.
Weak polynomial identities and their applications
Authors: Drensky Vesselin 
Published: July 2021

Abstract
Let R be an associative algebra over a field K generated by a vector subspace V. The polynomial f(x
1, . . . , xn
) of the free associative algebra K〈x
1, x
2, . . .〉 is a weak polynomial identity for the pair (R, V) if it vanishes in R when evaluated on V. We survey results on weak polynomial identities and on their applications to polynomial identities and central polynomials of associative and close to them nonassociative algebras and on the finite basis problem. We also present results on weak polynomial identities of degree three.
A design methodology for programmable-gain low-noise TIA in CMOS
Authors: Romanova Agata , Barzdenas Vaidotas 
Published: July 2021

Abstract
The work reports on the design of an area-efficient inductor-less low-noise CMOS transimpedance amplifier suitable for entry-level optical time-domain reflectometers. The work suggests a novel approach for implementing a programmable-gain in capacitive feedback TIA with an independent adjustment of the low- and high-frequency behavior using the input stage biasing impedance and one of the feedback capacitors. The approach addresses a typical noise problem of fast feed-forward or resistive feedback topologies while alleviating the trade-off of the key TIA performance indicators. A more accurate amplifier model is proposed which takes into account the effects due to capacitive isolation and both biasing circuits. Further modifications to the reference design are suggested including the PMOS-based implementation of the biasing circuit to address the voltage headroom issue. The circuit was implemented using a standard 180 nm CMOS process and operates from 1.8 V supply with the drawn current of 11.7 mA.
Analysis of Methods for Preventing and Fighting the Self-Heating Phenomena of Coal Used in Jiu Valley Mines
Authors: Rogobete Marius 
Published: July 2021

Abstract
This paper deals with the analysis of two cases of coal self-heating from two longwall mining within the coal exploitations belonging to Complexul Energetic Hunedoara, phenomena that started similarly but later evolved differently, as a result of prevention methods applied or not applied in each case. For the analysis of these self-heating phenomena, the data collected after the occurrence of the first signs were used, respectively the emission of carbon monoxide in the longwall mining area, until the moment of desertion and closure of the longwall with dams in the first case and eradication of the phenomenon in the second case. By analyzing in parallel the two cases, several conclusions are drawn which may help to counteract these types of phenomena that may occur in the longwall exploited in similar conditions.
Spatial Representation of Useful Minerals Deposits
Authors: Herbei Mihai Valentin , Herbei Roxana Claudia , Filip Larisa Ofelia 
Published: July 2021

Abstract
Starting from the fact that in the mining industry and in general in the field of underground constructions, the topographic activity, regardless of which of its manifestations, conditions and substantiates the achievement of economic and technological objectives, implicitly resulting in the dependence between topographic precision and qualitative and quantitative performance of mining. The level at which the professional responsibility of the topographic activity, as a whole is engaged in the achievement of some proposed objectives, depends on the framework resulting from the technological complexity of the mining activity in the conditions of its restructuring and efficiency. Spatial representations of useful mineral deposits in the earth's crust, which meet the quality conditions necessary for the design of underground mining works, can be used to choose the most efficient methods of opening, preparation and exploitation of useful mineral deposits. These analyzes are the basis for the realization of underground topographic networks that have a precise connection with the topographic base at the surface. The use of stereographic projection and stereographic networks can be achieved by faithfully representing the tectonics and positioning of deposits of useful mineral matter inside the earth's crust.
Biomechanics of Rotational Movement in Off-Ice Figure Skating Jumps: Applications to Training
Authors: Mazurkiewicz Anna 
Published: July 2021

Abstract

Introduction
The aim of this study was to characterize kinematic parameters of the rotational body movement during the office figure skating multi-revolution jumping exercise and to propose applications to training.

Material and Methods
Six elite Polish female junior singles figure skaters were examined performing single and their respective maximum total rotation vertical jumps in off-ice conditions. Measurements of the ground reaction force were performed with a KISTLER (500 Hz) piezoelectric sensor platform with BioWare Software, synchronized with the cinematographic analysis using the Vicon T-Series motion capture system.

Results
The analysis revealed positive linear relations between selected jump parameters of the pre-take-off phase and after the landing. Two moments of countering torque were also noticed: the first in the landing phase, and the second before reaching the stabilized position.

Conclusions
Applications of the findings for off-ice training were discussed.
Numerical Estimation of Hull Hydrodynamic Derivatives in Ship Maneuvering Prediction
Authors: Kołodziej Radosław , Hoffmann Paweł 
Published: July 2021

Abstract
Prediction of the maneuvering characteristics of a ship at the design stage can be done by means of model tests, computational simulations or a combination of both. The model tests can be realized as a direct simulation of the standard maneuvers with the free running model, which gives the most accurate results but is also the least affordable, as it requires a very large tank or natural lake, as well as the complex equipment of the model. Alternatively, a captive model test can be used to identify the hydrodynamic characteristics of the hull, which can be used to simulate the standard maneuvers with the use of dedicated software. Two types of captive model tests are distinguished: circular motion tests (CMT) and planar motion mechanism tests (PMM). The paper presents an attempt to develop a computational method for ship maneuverability prediction in which the hydrodynamic characteristics of the hull are identified by means of computational fluid dynamics (CFD). The CFD analyses presented here directly simulate the circular motion test. The resulting hull characteristics are verified against the available literature data, and the results of the simulations are verified against the results of free running model tests. Reasonable agreement shows the large potential of the proposed method.
Minimizing Greenhouse Gas Emissions From Ships Using a Pareto Multi-Objective Optimization Approach
Authors: Domachowski Zygfryd 
Published: July 2021

Abstract
To confront climate change, decarbonization strategies must change the global economy. According to statements made as part of the European Green Deal, maritime transport should also become drastically less polluting. As a result, the price of transport must reflect the impact it has on the environment and on health.
In such a framework, the purpose of this paper is to suggest a novel method for minimizing emissions from ships, based on so-called Pareto multi-objective optimization. For a given voyage by a ship, the problem is to minimize emissions on the one hand and minimize fuel consumption or passage time on the other. Minimizing emissions is considered as the preferred objective. Therefore, the objective of minimizing fuel consumption or passage time needs to be reformulated as a constraint. Solving such a problem consists of finding most favourable path and speed for the ship and satisfying the optimization criteria.
Relatively new systems such as hybrid diesel–electric systems have the potential to offer significant emissions benefits. A hybrid power supply utilizes the maximum efficiency of the direct mechanical drive and the flexibility of a combination of combustion power from the prime mover and stored power from energy storage from an electrical supply, at part load and overload.
A new report by the American Bureau of Shipping suggests that maritime transport is likely to meet the International Maritime Organization’s target by 2030, solely by using current technology and operational measures. However, this would not be enough to attain the target of reducing CO2 emissions by 2050 by at least 50% compared to 2008. New technologies and operational methods must be applied.
Impact of Language Style on Purchase Intention Mediation Effect of Perceived Credibility: Case from Pakistan
Authors: Hussain Qamar , Ghazanfar Sidra , Abdullah Muhammad , Ahmad Waqar 
Published: July 2021

Purpose: The current study investigates the new impact of the language style of online reviews (figurative vs. literal) on customers' perceived credibility and purchase intention the use of figurative language to advertise product quality and social presence has been advocated in previous marketing research.
Design/Methodology/Approach: The theory of expectation is adopted that is developed by Victor Vroom, is used in this study. It claims that a person would act or behave in a certain way because they are motivated to choose a specific behavior over others because of the desired output of that activity. A Google Forms quiz was created to collect data from persons who have done online purchasing. They were divided into two groups. The sentiment is echoed by a sample of 334 Pakistani students. The results were assessed using structural equation modeling (SPSS).
Findings: The findings show that consumers' purchasing intentions are influenced by both the language style of online reviews and their perceived reliability. Literal reviews, as opposed to figurative reviews, can increase users' desire to purchase search products. Consumers' willingness to buy experience products may be improved through figurative reviews.
Implications/Originality/Value: In the context of Pakistan customer's trust in online shopping is not good. They think these platforms are not trustworthy. With the help of Literal reviews’, we can build customers' trust in online shopping.
Measurement and Determinants of Financial Performance of Modaraba Companies: A Case Study of Pakistan
Authors: Khan Qaisar Maqbool , Kouser Rehana 
Published: July 2021

Purpose: Profitability measurement is a comparative statistic that describes the relationships between overall profit and other financial determinants of the firm.
Design/Methodology/Approach: The focus of this study is to measure the technical (TE), pure technical (PTE) and scale efficiency (SE) scores via Data Envelopment Analysis (DEA) of modaraba companies operating in Pakistan. The next stage is to study the empirical relationship between profitability, liquidity, leverage, and macroeconomic performance drivers. Financial statement data for 2010 to 2019 have been analyzed.
Findings: Empirical findings of descriptive statistics, correlation and regression were measured. These empirical results reveal that capital ratio (CR) and operating expenses to net income (OENI) had negative correlation with PTE, SE and TE. Whereas the age of the firm had a negative correlation with PTE and TE and positive correlation with SE, moreover, exchange rate (EXC) PKR to USD, log of total assets (LTA) and management expenses (ME) had negative correlation with SE and positive correlation with PTE and TE. Furthermore, inflation (INF) had negative correlation with PTE and positive correlation with SE and TE. Moreover, number of certificates (NOC) had negative correlation with SE and TE and positive correlation with PTE.
Implications/Originality/Value: Findings will be helpful to the management and policy makers for enhancing future financial performance by concentrating on these economic factors. More detailed and extensive data from the financial and non-financial aspects is suggested to support the hypothesized relationship of efficiency measures and determinants.
Blood Glucose Detection Using 3-LEDs: Analytical Model
Authors: Gabriela Pedro Bruna , Bertemes Filho Pedro 
Published: July 2021

Calibration of non-invasive blood glucose measuring devices have an important role in the routine of people with diabetes. Continuous monitoring is one of the most efficient manner to control the disease. Besides the errors associated with the user, the calibration of such devices is the key point for obtaining reliable data. Researchers have failed to correlate the 2 near-infrared-light wavelength response from skin with the blood glucose level and then use it for diagnosing both upper and lower glycaemia status. The aim of this article is to purpose a mathematical model for calculating the blood glucose level using 3-LEDs with different wavelengths. It is presented and demonstrated all equations involved by using the theory of absorption of light by photoplethysmography. The final proposed equation can be calculated without using prior data obtained from patient. It can be concluded that it is possible to reduce the necessity of using calibration processes before acquiring data by a non-invasive device.
Atención materno infantil dirigida hacia la comunidad
Authors: Mena González Patricio 
Published: July 2021

El análisis de nuestras cifras de salud muestra altas tasas de mortalidad materna, de mortalidad perinatal, aborto provocado y desnutrición materna. Junto a estas cifras, destaca el daño cerebral mínimo, con secuencia de la mal nutrición fetal, anoxia intraparto y/o desnutrición de los p rimeros meses de vida post parto. Una fórmula orgánica para el enfoque de esta programática podría ser la ampliación de los actuales programas maternales hacia programas integrales de atención de la mujer y la definición dentro de este programa de un sub programa de atención selectiva del alto riesgo obstétrico. Fundamenta el sub programa el hecho de que el alto riesgo se concentra en un pequeño grupo de madres que acumulan la mayor parte de la mortalidad y de los recursos anestésico-quirúrgicos. Parece razonable acumular recursos técnicos y humanos de alta calidad en aquellas pacientes sometidas a un mayor riesgo.
HISTERECTOMIA ABDOMINAL vs. VAGINAL
Authors: Valdivia Ponce Eduardo 
Published: July 2021

Se define la Histerectomía. Se revisan las indicaciones para ella. Se consideran dos vías para la Histerectomía: la vaginal y la abdominal. Se recalcan las indicaciones de cada uno; las facilidades, dificultades y limitaciones que brinda cada una de ellas.