bluuebunny/crossref_metadata_2025_split huggingface dataset:
Work Relationship Terminated Employees Legal Protection To Get Severance Payment From PT. Kertas Lecess Related To Law Of Bankruptcy And Law Of Labor
Authors: RafaRayya Susilawati Ussy 
Published: May 2020

This research titled is work relationship terminated employees legal protection to get severance payment from PT. Kertas Lecess related to law of bankruptcy and law of labor. The position of the worker or labor can be seen in two aspects, namely in terms of juridical and socio-economic aspects. From a socio-economic point of view, workers need legal protection from the state for the possibility of arbitrary action by entrepreneur. The form of protection provided by the government is by making regulations that bind workers and employeee, in this case there is Law Number 37 of 2004 concerning Bankruptcy and Delaying Obligations of Debt Payment Jo. Law Number 13 of 2003 concerning Labor Jo. MK Decision No. 67 / PUU-XI / 2013PT. The regulation is used as a basis for employees of PT. Kertas Lecess to sue the BUMN to be declared bankrupt and responsible for paying severance for its employees. PT. Kertas Lecess is a state-owned enterprise (BUMN), which went bankrupt in September 2019. There are around 1800 workers who must receive termination of employment. The value of severance payment for workers affected by layoffs is around Rp. 300 billion. Employees affected by layoffs protest because they have not received severance payment and even 1,900 employees who have not received their salary for 4 years. PT. Kertas Lecess was decided bankrupt by the Surabaya Commercial Court as a result of the cancellation of the peace proposal submitted by 15 of his employees on September 25, 2018. With the above considerations, the Panel of Judges of the Surabaya District Court, decided to grant the request for a cancellation of peace (Homologation) and stated that PT. Kertas Lecess is proven guilty of negligence for the non-payment of the salaries of PT. Kertas Lecess employees.
Vorausschauende Instandhaltung – Wenn der Digitale Schatten an seine Grenzen stößt
Authors: Werner Andreas , Angadi Veerendra C. , Lentes Joachim , Mousavi Alireza 
Published: June 2020

Kurzfassung
Datengetriebene Modelle zur Analyse von Produktionssystemen gewinnen in der Industrie an Bedeutung. Wesentliche Vorteile bei ihrem Einsatz sind, dass die Erzeugung sogenannter Digitaler Schatten nur auf gemessenen Sensordaten basiert und bestehende Datenschnittstellen und Analyseverfahren für Vorhersagen genutzt werden können. Datengetriebene Ansätze stoßen jedoch an Grenzen, da sie lediglich aus vergangenen Ereignissen Trends extrapolieren. Es fehlen häufig relevante Daten zu Ausfallszenarien, die bis dato real nicht aufgetreten sind. Somit entsteht ein Bedarf für sogenannte Digitale Zwillinge zu Analysezwecken, welche datengetriebene und physikbasierte Modelle zusammenführen, um repräsentative prädiktive Aussagen, wie die Restnutzungsdauer von Maschinenkomponenten zu ermöglichen. Im EU-geförderten Projekt Z-BRE4K werden Ansätze zur Harmonisierung datengetriebener und physikbasierter Modelle für die vorausschauende Instandhaltung gemeinsam mit Industrieanwendern erforscht, entwickelt und erprobt, welche im Rahmen dieses Beitrags vorgestellt werden.
Modern factories of regional engineering-geological conditions of Ukraine changes
Authors: Rudko H. I. , Yakovlev Ye. O. 
Published: June 2020

The article analyzes modern regional changes in engineering and geological conditions of Ukraine due to the complex impact of technogenesis and global climate changes. This is primarily due to the predominance of loess and loamy loess rocks in the upper part of the geological section (up to 65 % of the state) in the formation of technogenic-geological systems “technogenic object-geological environment”. Regional regulation of surface runoff (a cascade of reservoirs of the Dnieper River, up to 38000 pounds, network of channels) significantly disrupted the water-energy exchange of rocks within the upper zone of the geological environment, intensified regional changes of geomechanical parameters (compressive strength, adhesion, angle of a slope) to the factors of global climate change (increasing magnitude and uneven rainfall, warming etc.).
The authors evaluated the new processes of changes in engineering-geological parameters of loesses and loamy loess’ rocks due to the disturbances of their mass-energy (water-heat) transfer, the influence of seismic stresses, complex transformations of the geological environment of industrial-urban agglomerations. The performed analysis showed that changes in engineering-geological conditions are most actively developingwithin the sites of industrial-urban agglomerations, which is caused by the complex action of water and heat losses from engineering networks, changes in relief, geodynamic impacts of transport and construction works. Maximum changes of engineering-geological conditions within towns and settlements are observed in the developed (“old”) mining areas during the flooding of mines, subsidence of surface.
It is shown that a new model of the State Engineering-Geological Map of Ukraine is needed, scientific substantiation of the maximum permissible changes of the engineering-geological parameters of the geological environment for different technogenic-geological systems “technogenic object-geological environment”.
Implementation of Curriculum Innovation and Islamic Education Learning Basic Education/Implementasi Inovasi Kurikulum dan Pembelajaran Pendidikan Agama Islam Pendidikan Dasar
Authors: Supriyatno Triyo , Salamah Umi 
Published: May 2020

This study purposes to explore curriculum innovation and PAI teaching at SDIT Ahmad Yani in Malang. This research used qualitative approach with four research questions: How does the curriculum innovation, strategy, and media of PAI learning in SDIT Ahmad Yani Malang?Â Data collection was ended through interviews, observation and documentation. The results of the study are: The Learning used 2013 curriculum with a scientific-based approach, and KTSP curriculum. The model of learning is a goal-oriented, but the majority has lifted towards the process and achievement of competence, although not total. Applied learning methods have also experienced innovation in order to support a smooth learning. Media was used fairly well, but in order to support a smooth and achievement of learning in line with the principles alive in the curriculum applied, this fact needs to be improved towards better, both in terms of accuracy, presentation and materials used.
Potensi Debit Aliran Lokal Waduk Saguling Menggunakan Model Hujan Limpasan
Authors: Ferdiansyah Asep , Yuningsih Sri mulat , Ginanjar Mirwan Rofiq , Akrom Isnan Fauzan 
Published: May 2020

Saguling reservoir is one of the three largest reservoirs in the Citarum River Basin. The water source of its reservoir originates from Upper Citarum river basin, with gauging station located in Citarum-Nanjung and local discharge from tributaries around the reservoir. The problem is there is no observation of local discharge from the tributaries, thus its potential is estimated. The purpose of this study is to analyze the potential of local discharge with the Hydrology Engineering Center-Hydrologic Modeling System (HEC-HMS) model. The HEC-HMS Rainfall-runoff method is used for calculating the potential of the local discharge that flows into Saguling resevrvoir. The parameters used in the model are deficit constant (loss parameter), linear reservoir (baseflow parameter), dan lag time (transform parameter). Rainfall-runoff model produced good calibration values for Citarum-Nanjung Gauging Station with R2 of 0.8 and the Nash-Sutcliffe efficiency (NSE) value of 0.788. The verification result carried out in Saguling reservoir gives NSE of 0.8343 and R2 value of 0.83. The simulation shows that the potential discharge from local river contributes about 21.64% of the total discharge that entersÂ into the reservoir with monthly dependable flow for power plants, Q80 and Q85 values at 8,23 m3/s and 5,69 m3/s, respectively. The average discharge of local rivers can generate electricity of 3.89 MW - 162 MW.Keywords: Local discharge, rainfall runoff, potential discharge, Saguling reservoir
Study of the Stability of a Viscous Solution of Naftifin Hydrochloride with a Combination of Polyethylene Glycols for External Use
Authors: Kosenkova S. I. , Krasnyuk I. I. , Krasnyuk (jr.) I. I. , Belyatskaya A. V. , Stepanova O. I. , Mazyarkin E. V. , Korochkina T. V. , Kharitonov Yu. Ya. 
Published: May 2020

Introduction. An innovative antifungal viscous solution based on naftifine hydrochloride with a combination of polyethylene glycols (PEG) was developed in the laboratory of Sechenov University. The developed preparation intended for external use. The active ingredient – naftifine hydrochloride has a wide spectrum of action against fungi cause onychomycosis. The polyethylene glycols are included in the developed dosage form of provide the necessary viscosity of the solution (for accurate application and retention in the field of application). The paper presents the results of a study of the stability of a viscous solution of naftifine hydrochloride with a combination of PEG for external use. Over the entire shelf life, the drug must retain the full its chemical, physical, biopharmaceutical and pharmacological properties.Aim. Determination of stability and expiration date of the shelf life of the developed solution of naftifine hydrochloride for external use, intended for the treatment of mycosis of the nail.Materials and methods. Naftifine hydrochloride solution, «Millipor» filter, UV spectrophotometry, potentiometry pH, capillary viscometry.Results and discussion. In the course of the study, the shelf life of the developed alcohol solution of naftifin hydrochloride with a combination of PEG was experimentally determined. The stability of the dosage form was determined by accelerated aging at a temperature of 40 ± 2 °C, in vivo at a temperature of no higher than 25 °C; and in a refrigerator at a temperature of 8 ± 2 °C. Assessment of the stability of the alcohol solution of naftifine hydrochloride was carried out according to the following indicators: the volume of the contents of the bottle, appearance, pH, quantitative content of the active substance, viscosity.Conclusion. Based on the studies, it is recommended to store the naftifine hydrochloride solution at room temperature not higher than 25 °C, in a dark place. It is also allowed to store the solution of naftifine hydrochloride in a refrigerator at a temperature of 8 ± 2 °C.
Development of the Composition and Technology of a Granular Dosage form Based on a Thick Milk Thistle Extract and Ademetionine
Authors: Pisarev D. I. , Novikov O. O. , Zhilyakova E. T. , Boyko N. N. , Abramovich R. A. , Potanina O. G. , Lazar S. , Sayed Ahmad A. , Nasser R. 
Published: May 2020

Introduction. The creation of rational combined medicines with hepatoprotective activity is an urgent task of medicinal science. Ademetionin shows pharmacological ef-fectiveness in cytolysis, cholestasis, synthetic insufficiency. Silybin, in turn, is effective in cytolysis, synthetic insufficiency, mesenchymal inflammation, fibrosis and pathological regeneration. Thus, the combination of these substances covers almost the entire set of clinical and morphological syndromes of liver damage and has a wide range of effects in various liver pathologies.Aim. The purpose of this study was to develop a combined granular dosage form containing a thick extract of milk thistle, ademetionin and analytical support for this process.Materials and methods. To obtain a thick extract from the fruits of Silybum marianum L. a traditional percolation method was used in a battery of 3 diffusers. Extractant removal was performed using a rotary evaporator IR-1M3 under vacuum. For the analysis of silybin in the obtained thick extract from the fruit of S. marianum L. the method of HPLC was used. Validation evaluation of the method was performed according to generally accepted parameters.Results and discussion. A modular combined dosage form based on a thick extract of S. marianum L. and ademethionine was developed. Lactose was introduced as an auxiliary agent. The quality of pellets was evaluated according to generally accepted criteria. The validation parameters of the manufactured dosage form were determined using the HPLC method. Accuracy and precision were determined by the method of additives in a series of 9 experimental samples of granules. The results of determining the linearity, precision and correctness of the method for determining silybin and ademetionin in a combined model drug form showed correct results.Conclusion.Thus, a combined granular dosage form containing a thick extract of milk thistle, ademetionin, has been developed. Analytical support of this process using the HPLC method was performed. Validation studies of the developed methodology were carried out. The field of application of the obtained results is practical pharmacy. Further research should concern the conduct of a set of pharmacological tests.
The Study of Pharmacokinetics Parameters of Morphine Hydrochloride, Long-acting Tablets in Cancer Patients with Severe Chronic Pain Syndrome
Authors: Ezhova E. A. , Kotelnikova I. G. , Teteneva A. V. , Butuzova D. V. , Tetenev K. F. 
Published: May 2020

Introduction. Effective drug therapy for cancer patients with chronic pain syndrome (CPS) of high intensity is one of the priorities of modern healthcare. Currently, non-narcotic and narcotic analgesics are used for pain relief according to a three-steps scheme. In the absence of contraindications, it is preferable to prescribe medications per os and prolonged forms, which will allow the patient to maintain selfcare and comfort.Aim. To study the pharmacokinetic properties of a drug with a prolonged mechanism of action «Morphine hydrochloride», in a film-coated tablet formof a dosage 30 mg, in cancer patients with severe CPS.Materials and methods. For the analysis of the pharmacokinetics of the studied drug after single and multiple doses of 20 patients who received 10- day analgesic therapy with the studied drug «Morphine hydrochloride», long-acting film-coated 30 mgtablets. manufacturer FSUE Moscow Endocrine Plant, Russia. Route of administration: per os. The study duration was 17 days: screening duration up to 7 days; duration of therapy up to 10 days.Results and discussion. The concentration of morphine in plasma was determined by HPLC-tandem mass spectrometry, within 12 hours after taking the study drug (1 of long-acting, film-coated tablet 30 mg). The following pharmacokinetic parameters were obtained on Day 5: T1/2 – 6.08 ± 4.37 hours and 14.46 ± 30.86 hours, Tmax – 2.5 ± 1.86 hours, Cmax – 43.91 ± 27.24 ng/ml. Values of pharmacokinetic parameters averaged over all days are presented. It was found that T1/2 for the studied drug T1/2 is 9.21 ± 14.94 hours, Tmax 2.87 ± 2.36 hours. The average maximum concentration (Cmax) on the day of the study drug was 36.52 ng/ml.Conclusion. As a result of the study of pharmacokinetics, it was found that the drug «Morphine hydrochloride», long-acting tablets film-coated with a of 30 mg was found in serum after oral administration after 15 minutes and reaches a maximum concentration in the blood in 3 hours, the half-life is on average 9 hours, the maximum concentration is 36.52 ng/ml.
Results of the Estimation of Biosimilarity of RinLiz® (LLC «GEROPHARM», Russia) and Humalog® (Lilly France, France) Using the Method of the Hyperinsulinemic Eulygemic Clamp on Healthy Voluntary
Authors: Mayorov A. Yu. , Fedotov I. A. , Drai R. V. , Avdeeva O. I. , Makarenko I. E. 
Published: May 2020

Introduction. Insulin is the most effective hypoglycemic agent currently used in the clinical practice. Compared with recombinant human insulin, insulin lispro have a blood glucose profile that is much closer to physiological. The clinical trials program of insulin bioassays includes pharmacology studies: pharmacokinetics (PK), pharmacodynamics (PD), and a clinical safety study.Aim. To compare PK and PD of RinLiz® U100, solution for intravenous and subcutaneous administration (LLC «GEROFARM», Russia) and Humalog® U100, solution for intravenous and subcutaneous administration (Lilly France, France) in hyperinsulinemic euglycemic clamp.Materials and methods. This was randomized double-blind, two-arm crossover study in 28 healthy volunteers (NCT03604575). The studied preparations were injected before the clamp with a dose of 0.3 U/kg once subcutaneously in the area of subcutaneous fat in the anterior abdominal wall. During the study, regular blood sampling was performed; the amount of insulin lispro was determined by ELISA in the samples. The results of the determination were used to calculate the PK parameters and construct the curves «concentration – time». Based on the measurement of glycemia, the glucose infusion rate was adjusted. These data were used to calculate the PD parameters. The comparability of the studied drugs was considered proven if 90 % confidence intervals (CI) for the ratio of geometric mean PK parameters Cins. max and AUCins. 0-8 and 95 % CI for the ratio of geometric mean PD parameters GIRmax and AUCGIR0-8,5 were in the range of 80–125 %. Statistical data processing and presentation of the results was carried out using software packages R 3.4.2.Results and discussion. In the course of CI comparative PK and PD of RinLiz® and Humalog®, it was revealed that they have comparable PK and PD profiles. The CI for the logarithmically converted ratios of the values of the PK parameters was Cins. max 85.99–96.85 % and AUCins. 0-8 90.58–97.28 %, the PD of the parameters were 95.64–118.94 for GIRmax and 96.5–121.36 for AUCGIR0-8.5, all the CIs correspond to the set the boundaries of 80–125 % to establish comparability between RinLiz® and the original drug.Conclusion. The results demonstrated the high degree of similarity of RinLiz® U100 and Humalog® U100 in terms of PK, PD profiles and safety.
Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-UV Method
Authors: Komarov T. N. , Shohin I. E. , Miskiv O. A. , Bogdanova D. S. , Aleshina A. V. , Medvedev Yu. V. , Bagaeva N. S. 
Published: May 2020

Introduction. Viral infections are a serious problem that occurs during the use of immunosuppressants in preparation for organ transplantation and in the postoperative period. Cytomegalovirus (CMV) infection is one of the main causes of diseases in people with weakened immune systems. It has a direct impact on one’s body and makes it more likely to reject a transplanted organ. Antiviral drugs are used to treat and prevent this infectious disease. Valganciclovir is a prodrug whose active metabolite is ganciclovir. Valganciclovir is the drug of choice in the treatment of CMV infections. Currently, there are no researches on the matter of simultaneous determination of both valganciclovir and ganciclovir in human blood plasma by means of high-performance liquid chromatography (HPLC) with ultraviolet detection. This research delivers a thorough description of development and validation of a particular method for simultaneous determination of valganciclovir and ganciclovir in the plasma after sample preparation by the method of protein precipitation.Aim. The aim of this study is to develop method for the quantitative determination of valganciclovir and its active metabolite ganciclovir in human plasma by HPLC-UV for pharmacokinetic studies.Materials and methods. Quantitative determination of tadalafil in plasma by HPLC-UV. A sample was prepared using protein precipitation.Results and discussion. This method was validated by next validation parameters: selectivity, matrix effect, calibration curve, accuracy, precision, lower limit of quantification, carry-over and stability.Conclusion. The method of the quantitative determination of valganciclovir and its active metabolite ganciclovir in human plasma was developed and validated by HPLC-UV. The analytical range of the was 5,0–1000,0 ng/ml for valganciclovir and 100,0–10000,0 ng/ml for ganciclovir in plasma. Method could be applied to determination of valganciclovir and ganciclovir in plasma for PK and BE studies.
Immunogenicity Assessment of Pegfilgrastim in Patients with Breast Cancer
Authors: Medvedev Yu. V. , Kolganova M. A. , Sas O. A. , Komarov T. N. , Fisher E. N. , Shohin I. E. , Ammour Yu. I. 
Published: May 2020

Introduction. Neutropenia, which is an abnormally low concentration of neutrophils in the blood, is one of the common side effects in patients receiving radio- or chemotherapy. Neutropenia usually leads to higher risks of severe bacterial and fungal infections. Such medicines as colonystimulating factor filgrastim (and its conjugates) are used to prevent and treat neutropenia in oncology patients. Immunogenicity is a potential concern for any biological product, thus, its assessment is one of the most critical necessities during the development and registration of such products.Aim. The main aim of this study was to validate the ELISA method for anti-pegfilgrastim antibodies detection in human serum samples and to apply the validated method to pegfilgrastim drugs immunogenicity assessment.Materials and methods. To assess pegfilgrastim immunogenicity, the commercial ELISA kit «PEGylated Filgrastim (Neulasta®) ADA ELISA» was used for screening, confirmatory and titer assay. Moreover, to confirm the chosen commercial kit suits the study aims it was revalidated. The absorbance values were obtained using plate immunoassay analyzer Stat Fax 3200, plate washing was performed using an automatic twochannel plate washer.Results and discussion. The ELISA method for anti-pegfilgrastim antibodies determination in human serum samples was validated and applied to the analytical part of the comparative, multicenter, blind, randomized study of pegfilgrastim efficacy and safety in patients with breast cancer, receiving myelosuppressive chemotherapy. Human serum samples were first screened for anti-drug antibodies, then «screening positive» samples were analyzed in confirmatory assay with % inhibition calculation for each sample. The «confirmed positive» samples were further characterized in titer assay.Conclusions. The ELISA method for anti-pegfilgrastim antibodies determination in human serum samples was successfully validated and applied for pegfilgrastim drugs immunogenicity assessment.