bluuebunny/crossref_metadata_2025_split huggingface dataset:
Process Analytical Technology (PAT) in Quality Assurance: A Detailed Review
Authors: Shah Esha Bhavin , Gajjar Anuradha 
Published: February 2022

Process Analytical Technology (PAT) is a proactive initiative published by the Food and Drug Administration so as to overcome the conventional way of batch testing. As per the documented guideline it can be stated as a system for designing, analyzing, and controlling pharmaceutical manufacturing through the timely measurement of critical quality and performance parameters. PAT is a quality driven approach with innovative, strategic and rapid systems, so as to clearly understand, predict, manipulate, control and refine manufacturing processes. Owing to its multidimensional applications, process analysis can be carried out even in the most critical processes, like crystallization, by the on-line technique.PAT is one of the prime objectives stressed in the Initiative for Pharmaceutical CGMPs for the 21st Century published by the Food and Drug Administration. The chief motive of this dynamic approach is to carry out measurements on raw materials and in the in process materials or process parameters with tight controls, with a prime goal to enhance final product quality and reduce the chances of error or default/defect. The prime inventiveness of the PAT initiative is to focus on building quality inside the product and the entire manufacturing processes, in addition to continuous process improvement. The adoption of PAT approach can provide a plethora of benefits to the pharmaceutical industry by enhancing product quality while providing supercilious asset utilization and niche financial value. PAT bestows better insight of raw materials, by characterizing it physically and chemically, detailed understanding of manufacturing parameters, all of which collectively decide the fate of the quality and appeal of the final product. Unlikely to the traditional approach of testing the product at its terminal stage, PAT is a dynamic approach to keeping an eye on the manufacturing and other related processes on a continuous basis compared to a discrete one, and keeps a strict check at all stages of production. Hence this detailed review will stress on the importance of PAT and its overall conceptualization, which shall be indeed propitious for furnishing an integrated systems approach for quality design, process analyses, understanding and control, continuous improvement, knowledge and risk-based management within the FDA 21st century framework of Good manufacturing initiative and will be a useful guide to the industry and academia personnel for better understanding of this approach. Additionally it also highlights the unique synergy of Quality by Design with PAT for establishing an in depth understanding of the manufacturing process.
Design and Characterization of Thermosensitive Mucoadhesive Nasal Gel for Meclizine Hydrochloride
Authors: Malviya Vedanshu 
Published: February 2022

Background: The current study was to develop a thermoreversible nasal in-situ gel for meclizine hydrochloride. As meclizine hydrochloride is water-insoluble and is having a hepatic first-pass metabolism it becomes necessary to prepare a formulation that will enhance the absorption of the drug and gives sustained action in the body.
Method: The FT-IR and DSC study revealed that there was no incompatibility between the drug and the excipient. The inclusion complex of meclizine hydrochloride was prepared by employing Sulfobutyl-ether- β- Cyclodextrin (SBEβCD) and then using this complex the thermoreversible gel was prepared by using the cold method. The thermoreversible gel was prepared by incorporating various types of polymers like Carrageenan, HPMC, carbopol-934, and Sodium Alginate in different concentrations and was evaluated for the various evaluation parameters to identify the optimized formulation from the batches B1-B8.
Result: From the prepared formulation B6 was found to be optimized as it was having a higher drug concentration of 98.33±2.1547%, the mucoadhesive strength of 28.98±1.5692 dyne/cm2 in B6 showed that more drug can be retained in the body as compared with other formulations, more sustained release of drug was seen i.e. 87.42±1.4113% of drug release in 8 hours than compared with the other prepared formulation. The kinetics study reveals peppas model was best fitted to the optimized formulation with the regression coefficient of 0.9832. From the stability study, it was concluded that the prepared formulation was stable during the full time study and does not change its property with time.
Conclusion: The concentration of polymers was a significant factor in the % drug release in the formulation and also in the mucoadhesive strength of the formulation. Hence, it was concluded that the prepared thermoreversible nasal in situ gel was a successful approach in increasing the drug absorption in the body.
Comparative analysis of the use of technetium-99m labeled recombinant target molecules at doses of 1000 and 2000 μg for radionuclide diagnostics of HER2-positive breast cancer
Authors: Bragina Olga , Chernov Vladimir , Deev Sergei , Zelchan Roman , Medvedeva Anna , Lukina Natalia , Goldberg Viktor , Tolmachev Vladimir 
Published: February 2022

Materials and methods. The study included 18 patients with breast cancer (T1–4N0–2M0) before systemic treatment: 10 — with HER2/neu overexpression; 8 — HER2/neu negative. In all cases, morphological, immunohistochemical studies, as well as FISH analysis of the primary tumor were performed. All patients underwent radionuclide studies (planar scintigraphy and SPECT of the chest) at 2, 4, 6 and 24 hours after injection of the «99mTc-DARPinG3» in dosages of 1000 and 2000 μg.
Results. The half-life of the labeled protein from the blood was 3.5 hours for a dosage of 1000 μg; 3.8 h — for 2000 mcg. The organ with the highest absorption of «99mTc-DARPinG3» was the kidneys, regardless of the protein dose (0.10±0.02 and 0.10±0.03 mGy, respectively). The effective dose for 1000 μg was 0.011±0.001 mGy; for 2000 μg — 0.012±0.006. The liver absorption dose was significantly higher with 1000 μg of protein compared to 2000 μg (p<0.005, Mann–Whitney U test). The tumor/background ratio was significantly higher at 2 and 4 hours after administration of the «99mTc-DARPinG3» in patients with HER2-positive tumors in 1000 and 2000 μg doses of protein (p<0.005, Mann–Whitney U test).
Conclusion. Clinical studies of the «99mTc-DARPinG3» in dosages of 1000 and 2000 μg demonstrated rapid elimination from the bloodstream and effective doses comparable to those obtained in the study with others alternative scaffold proteins labeled with various isotopes. An essential point of this work is the positive correlation of the protein dose with the accumulation of the compound in the liver, which is important component in diagnostic and allows to detect tumor sites in liver.
Editorial
Authors: Gütl Christian 
Published: February 2022

Dear Readers,
It is my great pleasure to announce the second regular issue of 2022. In this issue, various topical aspects of computer science are covered by 17 authors from 6 countries in 5 articles. I would like to thank all the authors for their sound research and the editorial board for the highly valuable review effort and comments for improvement. These contributions, together with the generous support of the consortium members, sustain the quality of our journal.
In an ongoing effort to further strengthen our journal, I would like to expand the editorial board: If you are a tenured associate professor or above with a strong publication record, you are welcome to apply to join our editorial board. We are also interested in high-quality proposals for special issues on new topics and trends. Please consider yourself and encourage your colleagues to submit high-quality articles or special issues for our journal.
In the second regular issue, I am very pleased to introduce the following 5 accepted articles: In a collaborative research between Italy and Ireland, Luca Calderoni, Dario Maio, and Paolo Palmieri compare two probabilistic data structures for association queries derived from the well-known Bloom filter, and extend and optimize the functionality of the shifting Bloom filter, which is applicable to any non-trivial number of subsets. Zeinab Ghasemi-Naraghi, Ahmad Nickabadi and Reza Safabakhsh from Iran focus their research on multi-task learning, more specifically, they introduce a novel multi-task loss function to capture homoscedastic uncertainty in multi regression tasks models without increasing the complexity of the network. Daniel G&oacute;mez, Luis Llana and Crist&oacute;bal Pareja from Spain present and experimentally review a parallel version of the Brandes algorithm implemented in Spark to compute the betweenness centrality measures. V&iacute;t Novotn&yacute;, Michal &Scaron;tef&aacute;nik, Eniafe Festus Ayetiran, Petr Sojka and Radim &#344;eh&#367;&#345;ek from the Czech Republic propose and evaluate a constrained positional model that adapts the sparse attention mechanism from neural machine translation to improve the speed of the positional model. Mahmut &Uuml;nver, Atilla Erg&uuml;zen and Erdal Erdal from Turkey focus their research on an approach based on distributed file systems for managing large amounts of data generated by distance education.
The Development of Learning Media Based on Augmented Reality, Hologram, and Ludo Game on The Topic of Molecular Shapes
Authors: Hakiki Rifqon , Muchson M. , Sulistina Oktavia , Febriana Asia 
Published: February 2022

This Currently, technology-based learning media is needed to attract students' learning interest. Augmented Reality and Hologram, both technologies are able to answer these problem. In addition, the Ludo Game can also increase the student’s learning interest when applied as a learning media. This study aims to: developing a learning media based on Augmented Reality, Hologram, and Ludo Game on the topic of molecular shapes, as well as knowing the feasibility of this learning media. Research and Development (R&D) is used as research methods. The development of media adapted the ADDIE model, which includes the stage: assessment/analysis, design, development, implementation, and evaluation. The feasibility of this learning media is based on the results of product validation as a learning media, material, and small group trials of 17 Senior High School students. The results of study found that the percentage of product validation results as a learning media is 85,56% (very feasible), material is 88,00% (very feasible), and small group trials is 87,25% (very feasible). Based on this, it can be concluded that this learning media is very feasible to be implemented in the study on the topic of molecular shapes.
Surveillance of synthetic acaricide efficacy against Varroa destructor in Ontario, Canada
Authors: Morfin Nuria , Rawn Devan , Petukhova Tatiana , Kozak Paul , Eccles Les , Chaput Jim , Pasma Tim , Guzman-Novoa Ernesto 
Published: February 2022

Abstract
The parasitic mite Varroa destructor (Mesostigmata: Varroidae) is the main culprit of honey bee (Hymenoptera: Apidae) colony mortality in Ontario, Canada. Most beekeepers use synthetic acaricides to control V. destructor infestations in their colonies, but the use of these products increases the risk of V. destructor developing resistance to the active ingredients, which is a growing concern. This study sought to determine the efficacy of three synthetic acaricides approved for use in Canada for control of V. destructor infestations, amitraz (Apivar™), tau-fluvalinate (Apistan®), and flumethrin (Bayvarol®), using the Pettis test. The mite mortality rate in populations of V. destructor differed for the acaricides tested. Amitraz caused a significantly higher mite mortality rate (92%) than flumethrin (78%) and tau-fluvalinate (72%) did. Amitraz was classified as “mostly effective” (90–97%), whereas flumethrin and tau-fluvalinate were classified as “minimally effective” (< 80%) for V. destructor control in the mite populations studied. Variation in mite mortality due to acaricide exposure was observed between apiaries and regions. The results highlight the importance of periodically assessing the varroacidal activity of acaricides to inform decisions to control the parasite when implementing integrated pest management strategies.
T-LYMPHOCYTES EXPRESSION OF TOLL-LIKE RECEPTORS 2 AND 4 IN ACUTE MYELOID LEUKEMIA PATIENTS WITH INVASIVE FUNGAL INFECTIONS
Authors: Abdel Hameed Muhamad R. , Elgendy Sherein G. , El-Mokhtar Mohamed A , Sayed Douaa , Mansour Samar M. , Darwish Abeer M. 
Published: February 2022

Background: Invasive fungal infections (IFIs) are important cause of mortality in acute myeloid leukemia (AML) patients on treatment with intensive induction chemotherapy. Toll-like receptors, mainly Toll-like receptors 2 and 4 (TLR2 and TLR4), play a considerable role in the host defense against microorganisms. The expression of TLRs and their association with the occurrence of IFIs in patients with AML remains unclear. The aim of this study was to investigate the associations between the T-lymphocyte expression of TLR2 and TLR4 and the occurrence of IFIs in AML patients treated with intensive induction chemotherapy. Materials and Methods: One hundred twenty two newly diagnosed AML patients were evaluated. The laboratory diagnostic techniques for IFIs include culture, microscopic examination, histopathology, galactomannan assay and PCR. The expressions of TLR2 and TLR4 were analyzed by flow cytometry. The Control group included 20 age and sex-matched individuals. Results: There was a significant increase in the expression of TLR4 in AML patients with IFI compared to healthy controls (p = 0.001). TLR2 and TLR4 expressions increased significantly in AML patients with mixed fungal and bacterial infection compared to healthy controls (p= 0.002 and p=0.001, respectively). Conclusion: TLRs expressions could be important biological markers for the occurrence of IFI in AML patients after intensive induction chemotherapy.

Keywords: Invasive Fungal Infection, TLR2, TLR4, Acute Myeloid Leukemia
Comparison of Different Sampling Methods to Catch Lymphatic Filariasis Vectors in a Sudan Savannah Area of Mali
Authors: Coulibaly Yaya Ibrahim , Sangare Moussa , Dolo Housseini , Doumbia Salif Seriba , Coulibaly Siaka Yamoussa , Dicko Ilo , Diabate Abdoul Fatao , Coulibaly Michel Emmanuel , Soumaoro Lamine , Diallo Abdallah Amadou , Dembele Massitan , Traore Sekou Fantamady , Stanton Michelle , Koudou Benjamin Guibehi , Klion Amy D. , Nutman Thomas B. , Kelly-Hope Louise , Bockarie Moses John 
Published: February 2022

ABSTRACT.
There is a need for better tools to monitor the transmission of lymphatic filariasis and malaria in areas undergoing interventions to interrupt transmission. Therefore, mosquito collection methods other than human landing catch (HLC) are needed. This study aimed to compare the Ifakara tent trap type C (ITTC) and the Biogents sentinel trap (BGST) to the HLC in areas with different vector densities. Mosquitoes were collected in two villages in Mali from July to December in 2011 and 2012. The three methods were implemented at each site with one ITTC, one BGST, and one HLC unit that consisted of one room with two collectors—one indoor and the other outdoor. The Anopheles collected in 2011 were individually dissected, whereas those from 2012 were screened in pools using reverse transcription-polymerase chain reaction (RT-PCR) to determine the maximum infection prevalence likelihood (MIPL) for Wuchereria bancrofti and Plasmodium falciparum. The dissection of the females also allowed to assess the parity rates, as well its results. Over the 2 years, the HLC method collected 1,019 Anopheles, yields that were 34- and 1.5-fold higher than those with the BGST and ITTC, respectively. None of the dissected Anopheles were infected. The RT-PCR results showed comparable MIPL between HLC and ITTC for W. bancrofti with one infected pool from each trap’s yield (respectively 0.03% [0.0009–0.2%] and 0.04% [0.001–0.2%]). For P. falciparum, no infected pool was recovered from BGST. The ITTC is a good alternative to HLC for xenomonitoring of program activities.
Malaria Relapses Following Parasite-Free Blood Transfusions in the U.S. Army during the Korean War
Authors: Shanks G. Dennis , Waller Michael 
Published: February 2022

ABSTRACT.
Latent Plasmodium vivax parasites in the liver known as hypnozoites activate causing malaria relapses months after the original infection. The putative initiation signal is unknown. Plasmodium falciparum infections appear to trigger P. vivax relapses and initiation of relapse may be triggered by hemolysis or fever. The U.S. Army hospital records from the Korean War (> 500,000 individual records) were used to determine whether there was an association between blood transfusion and vivax malaria relapse. Importantly, blood for transfusion was collected in the United States, so the risk of transmission of malaria parasites was minimal. Blood transfusion (largely for combat trauma) was a risk factor for subsequent vivax malaria (relative risk 2.54, 95% CI 2.15–2.99, P < 0.0001). As expected, blood transfusion was not a risk factor for subsequent dysentery, but transfusion was a risk factor for subsequent hepatitis. Blood transfusion causing an increased heme delivery to the liver and a subsequent redox signal within hepatocytes may partially explain hypnozoite activation leading to relapses of vivax malaria.
Determinants of technical efficiency among lowland rice farmers in Enugu State, Nigeria: a stochastic frontier production function approach
Authors: Okoh T.C. , Opata P.I. , Ibe J.C. , Onyenekwe S.C. , Ikubaiyeje K.P. , Ettum P.O. 
Published: February 2022

The study examined the determinants of technical efficiency among lowland rice farmers in Enugu State, Nigeria. Primary data were sourced from rice producers through the use of well designed questionnaires. The study was conducted in four agricultural zones of Enugu State, during the 2017/2018 cropping season. Multistage and simple random sampling technique was employed to select 300 sampled rice farmers for the study. Cobb-Douglas stochastic production frontier function was used for the analysis.The result revealed that (98%)of random variation in the output of farmers was because of their inefficiency in their use of productive inputs in the study area. .Apart from farm size with estimated coefficient of (0.0531), fertilizer (0.0329), seed (0.2319), labour (0.0804) and agro-chemical (0.1711) were underutilized by the rice farmers. The average technical efficiency for the farmers was 0.71 implying that, on the average, the respondents are able to obtain 71% of potential output from a given mixture of production inputs. Thus, in a short run, there is a minimal scope (29%) of increasing the efficiency, by adopting the technology and techniques used by the most technically efficient farmer. High cost of inputs (MS=3.69), bad roads (MS=3.67), poor credit accessibility (MS=3.40) and inadequate storage facilities (MS꞊2.90) were found to be the major constraints of the rice farmers. The study recommends that in order to improve efficiency of resource use by the farmers in the study area, more of labour, seed, fertilizer and agro-chemicals should be utilized.
BARYMETRIC CHARACTERIZATION OF ALGERIAN SHEEP BREEDS IN WESTERN ALGERIA
Authors: Belharfi Fatima Zohra , Djaout Amal , Ameur Ameur Abdelkader , Gaouar Semir Bechir Suheil 
Published: February 2022

To study of the biodiversity of the sheep genetic resources, our phenotypic approach consists on the barymetric parameters of Algerian sheep breeds in western Algeria using the body measurements in 166 sheep of six breeds: Ouled Djellal, Hamra, Barbarine, Srandi, Daraa and Tazegzawt. The body measurements studied are: WH, SIL, HG, CD, SW, RW, TW, PL, HL, HW, EL, EW and CP, they are respectively : 84.71±7.15 cm ; 84.08±7.96 cm 103.53±10.79 cm ; 30.21±4.18 cm ; 17.34±2.09 cm ; 21.63±2.90 cm ; 26.01±2.32 cm ; 24.40± 4.07 cm ; 25.58±1.99 cm ; 15.18±1.62 cm ; 16.22±2.60 cm ; 8.24±0.96cm et 9.09±1.21 cm. The barymetric characterization revealed clear barymetric diversity between the breeds studied and between males and females, with very highly significant differences (p<0.001) for the most of body measurements used. A principal component analysis (CPA) was performed on the barymetric characteristics, revealed two main principal components accounting for 55.63% and 18.02% of the inertia, being related to WH, HG, CD, TW and SIL. The results of the CPA allowed establishing 3 classes, which only one class presents the majority of the population.
Nigerian Fulani Ecotype Chickens: Growth Performance under Two Production Systems
Authors: Sanusi Adenike , Oseni Saidu 
Published: February 2022

The study evaluated the growth performance of Nigerian Fulani ecotype chicken (NFEC) under intensive and pastured poultry production systems. Two hundred (200) day-old chicks of Nigerian Fulani ecotype chicken (NFEC) were obtained from established stocks of NFEC population at the Teaching and Research Farm, Obafemi Awolowo University, Ile-Ife, Nigeria. The chickens were separated randomly to intensive and pastured poultry production systems at 12 weeks of age. Data on body weight were taken weekly from day-old to 20 weeks. Data were analyzed using PROC GLM of SAS® at statistical significance level of P<0.05. Results showed significant effect of sex of chicken from the 10th to the 20th week of age (P<0.05). Significant interaction effect was observed between sex and production system at weeks 16 and 18 (P<0.05) when the male chickens under the intensive production system outpaced their male counterparts in the pastured poultry. Average daily gain for the period of 20 weeks was 6.83g and 9.21g for female and male chickens respectively. Weight gain pattern across weeks was not uniform. Therewas no significant difference in the growth rate in the two production systems (P>0.05).
The nocturnal behaviour of African elephants (Loxodonta africana) in Aalborg Zoo and how changes in the environment affect them
Authors: Andersen Tobias Astell , Herskind Christinna , Maysfelt Julie , Rørbæk René Worup , Schnoor Christina , Pertoldi Cino 
Published: February 2022

Elephants’ nocturnal behaviours are an important part of their welfare in captivity. For this reason, this study investigates whether the nocturnal behaviour of three African elephants’ (Loxodonta africana) in Aalborg Zoo is affected when exposed to different conditions and if they are affected differently. Camera footage was used to log the elephants’ behaviours at night during a control period and during two periods with different impacts, which consisted of six nights respectively. Every night, the elephants were captured on video from 8 pm to 8 am and the behaviours were subsequently logged every second following an ethogram containing seven behaviours. This study was not able to show an effect (p > 0.05) on the elephants’ nocturnal behaviour related to an increase in visitor activity during the Autumn holiday. However, a significant increase in the duration of the sway behaviour was found after the shift from daylight saving time to standard time. This study also found that the elephants show individual norms within the behaviours such as interaction with food and abnormal behaviours. The lack of statistical evidence for changes in nocturnal behaviour related to visitor activity, may be due to other external factors influencing the nocturnal behaviour of the elephants. Swaying behaviour was affected by the shift to standard time of all three elephants. Individual differences in nocturnal behaviours indicate that the three elephants have different animal personalities.