bluuebunny/crossref_metadata_2025 huggingface dataset:
Drug Coated Balloon Angioplasty in Failing AV Fistulas
Authors: Trerotola Scott O. , Lawson Jeffrey , Roy-Chaudhury Prabir , Saad Theodore F.
Published: July 2018

Background

Restenosis remains a problem in hemodialysis access interventions. Paclitaxel-coated balloons have shown promise in reducing access-related restenosis in small trials. The primary hypotheses for our multicenter trial were superior effectiveness at 180 days and noninferior safety at 30 days of a drug-coated balloon compared with conventional angioplasty for treatment of dysfunctional arteriovenous fistulas.

Design, setting, participants, & measurements

This randomized trial enrolled 285 patients with dysfunctional arteriovenous fistulas at 23 centers. Grafts, central venous stenoses, thrombosed fistulas, and immature fistulas were excluded. All patients received angioplasty of the lesion responsible for access dysfunction. After successful angioplasty (≤30% residual stenosis), lesions were treated with either a paclitaxel-coated balloon or an uncoated control balloon of similar design to the drug-coated balloon. Access function during follow-up was determined per centers’ usual protocols; reintervention was clinically driven. The primary efficacy outcome assessment was done at 6 months, and the safety assessment was done within 30 days of the procedure. Prespecified secondary end points included assessment of postintervention target lesion primary patency and access circuit primary patency at 6 months.

Results

The 180-day end point was not met with target lesion primary patency (71%±4% for the drug-coated balloon and 63%±4% for control; P=0.06), representing a difference of 8%±6% (95% confidence interval, −3% to 20%). Access circuit primary patency did not differ between groups. Interventions to maintain target lesion patency were fewer for the drug-coated balloon at 6 months (0.31 versus 0.44 per patient; P=0.03). The primary safety noninferiority end point was met and did not differ between groups (P=0.002).

Conclusions

Paclitaxel-coated balloon–assisted angioplasty did not meet the primary effectiveness end point at 180 days compared with conventional angioplasty. Both arms showed equivalent safety (ClinicalTrials.gov number NCT02440022).
OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION
Authors: Badjatya Jitendra Kumar
Published: July 2018

Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrumcovering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulatedindustries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceuticalindustries and worldwide regulatory agencies. Regulatory Affairs (RA), is a profession within synchronized variousindustries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a veryspecific meaning within the pharmaceutical industries.DRA is a dynamic, rewarding field that includes both scientific and legal aspects of drug development. DRA professionalsare dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples.RA as profession is broader than registration of products, they advise companies both strategically and technically at thehighest level. Their role begins right from development of a product to making, marketing and post marketing.Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientificthinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are alsoplaced upon the claims which can be made for the product on labeling or in advertising.
EFFECTS OF PH, SALT, TEMPERATURE ON CONVENTIONAL LIPOSOMES SIZE ENLARGEMENT ANALYZED BY OPTICAL MICROSCOPE
Authors: Maurya Sheo Datta
Published: July 2018

The objective of the present study was to investigate the effects of experimental conditions like pH, salt, temperature on the interactions of conventional liposomes. The model drug Stavudine was entrapped in the liposomes composed of Phosphotidyl Choline and cholesterol in the ratio of 200mg: 80mg and prepared by thin film hydration method. Liposomes preparation was characterized and compared for particle size, mean dispersion, entrapment efficiency, Zeta potential and the size enlargement studies were carried out in optical microscope by using Magnus.
ORGANOGELS AS A POTENTIAL TOPICAL DRUG DELIVERY SYSTEM
Authors: Jha Shubhendra , Maurya Sheo Datta
Published: July 2018

Semisolid preparations for external application to skin have gained much demand, since it is easily absorbed through the skin layers. Many novel topical dosage forms have been discovered, among which organogels appears to play an important role. Interest in organogels has increased in a wide variety of fields including chemistry, biotechnology and pharmaceutics. Organogels are thermodynamically stable, biocompatible, isotropic gel, which not only give localized effect, but also systemic effect through percutaneous absorption. Organogels are semi-solid systems, in which an organic liquid phase is immobilized by a three-dimensional network composed of self assembled, intertwined gelator fibers. The apolar phase gets immobilized within spaces of the three-dimensional networked structure formed due to the physical interactions amongst the self assembled structures of compounds regarded as gelators. Organogels have been explored as matrices for the delivery of bioactive agents. Compared to conventional topical dosage forms, these novel formulations are found to be more advantageous and efficient. In future, organogels can give way to many promising discoveries in the field of topical dosage forms. The current review aims at giving an idea about organogels, its applications and importance in topical delivery.
DRUG PRODUCT REGISTRATION IN SEMI-REGULATED MARKET
Authors: Badjatya Jitendra Kumar , Bodla Ramesh
Published: July 2018

There found a diversity of regulatory requirement in Semi regulated market. This region consists of mainly thecountries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacificand Gulf have somewhat harmonized their regulatory environment through The Association of Southeast AsianNations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonizedregulations in their respective regions.The urgent requirement to rationalize & harmonize regulation was required by instance of rising cost of health care,research & development and to meet the public requirement for safe and efficacious treatments to patient in need.ICH committee has given priority to harmonize the format of reporting data for quality, safety and Efficacy in theapplication dossier.The commercial significance of ROW markets is increasing globally. It is crucial that pharmaceutical companies keepup-to-date with the latest regulatory developments to ensure their place on the ROW market.This paper favors the regulatory processes for gaining marketing authorization in ROW countries in terms oftechnical data requirement for the dossier.
HARMONIZATION & ADVANCEMENT IN PHARMACEUTICAL INDUSTRY
Authors: Badjatya Jitendra Kumar , Bodla Ramesh
Published: July 2018

The urgent requirement to rationalize and harmonize regulation was impelled by instance of rising cost of Healthcare, Research and Development and need to meet the public requirement to approach for the safe and efficacioustreatments to patient in need. ICH committee has given priority to harmonize the format of reporting data for quality,safety and Efficacy in the application dossier.ICH also provides different Guidelines under the topic Quality, Safety, Efficacy and Multidisciplinary to control thequality safety and efficacy of Pharmaceutical and Biotechnological products.For the dossier application part CTD provides harmonized format for product application. Earlier all the submissionssent to regulatory authorities in CTD, Paper format but it was a tedious job requiring lot of Time to review,documentation and paper work.Due to the advancement in Information technology, regulatory authorities from regulated countries throughout theglobe started to accept data in electronic format either in eCTD (Electronic common technical document)/ NeeS (NoneCTD electronic submission).The eCTD was developed subsequently by the ICH M2 Expert working group and allows for the electronicsubmission of the CTD from the applicant to regulator and provides harmonized technical solution for CTDelectronically. Many regulatory authorities completely eliminated the Paper submission and made eCTD mandatory.This is the centralized approach, saves time, cost, facilitate review process and greater transparency can be achievedvia central processing of submissions.Harmonization can also be seen in IPR stream by treaties and conventions. These international treaties andconventions contribute to the process of harmonization of patent laws.
NEED FOR DRUG PRICE CONTROL IN INDIA
Authors: Parasiya Sachin K. R. , Balamuralidhara V. , T.M Pramod Kumar , Dave A.J. , Gujarati R. , Shukla A.
Published: July 2018

India is one of the developing countries. A substantial proportion of population of this country is largely exposed to the drug market whose purchasing power is extremely low. Around 42% population of this country lives under the National poverty line ($1.25 per day).  Vital issue concerning them is to access the health care facility at an affordable cost. Medicine is a part of health care cost and it costs to around 70% to 80% of total cost. Thus, cost of medicine is a governing factor of health care system especially when it comes to price control of health care facilities. To bring down the cost of health care facilities, government spends money for health care facilities. A comparative expenditure made by state government is depicted in this article. NPPA (National Pharmaceutical Pricing Authority) is the Indian pharmaceutical pricing regulating authority and it achieves its objectives by implementing the DPCO (Drug Pricing control order). In spite of existence of the DPCO, drastic price variation is observed between the products of same API (Active Pharmaceutical Ingredient) and several factors are responsible for the same. To overcome the stated problem and monopolistic trade practice by patent holder/brand manufacturer, TRIPS (Trade Related Intellectual Properties Rights) provides Compulsory Licenses which has its unique role to play in affordability of medicines. Essential medicine is a basic requirement of health care system to serve their customers and hence an effective and overt price control on drugs is the need of present. This study will thus try to justify the need to bring NLEM (National List of Essential Medicine) under DPCO.
PLANT VARIETY PROTECTION LEGISLATION: OVERVIEW OF AN INDIAN AND AFRICAN PERSPECTIVE
Authors: Mathur V. , Musyuni P.
Published: July 2018

Plant Variety Protection (PVP) legislation provide for the establishment of an effective system for protection of plant varieties, the rights of farmers and plant breeders to encourage the development of new varieties of plants. The TRIPS agreement has established the minimum standards for protection and enforcement of plant varieties by the each member country. TRIPS left to each country’s discretion whether to protect new plant varieties by means of patent or by effective sui generis system or by any combination thereof. In India and Africa protection to new plant varieties is provided through PVP Acts. This paper discusses the salient features of the PVP laws of these countries. The PVP law affects the agriculture based economy in countries such as India and Africa in a significant way, thus, economic implications of this law are discussed herein.
MEDICINES HARMONIZATION IN WEST AFRICAN ECONOMIC AND MONETARY UNION (WAEMU) COUNTRIES
Authors: Amari A.S.G , N’Guessan A. , Sackou J.G. , Amonkou A.C. , Alloukou P.M. , Duncan R.
Published: July 2018

With the blessing of WHO, the different regions of West Africa engaged in Pharmaceutical regulation harmonization processes on the continent.

Indeed, In west Africa, WAEMU actions on the matter ended in the production of juridical rules opposable to member states who rationalize watching/control procedures and medicine marketing for both human medicine and veterinary products.

What remains then to member states is to appropriate community regulation hoping that Pharmaceutical cooperation reinforcement with ECOWAS, that other sub regional economical organization, grows stronger in order to improve drug use and manufacturing in West African area.
STEPS FOR SUCCESS IN SOURCING OF HARD GELATIN CAPSULES FOR PHARMACEUTICAL USE
Authors: Gupta Rajkumar
Published: July 2018

The sourcing of raw Gelatin for manufacturing hard Gelatin Capsules is a very critical function. It involves a thorough quality audit of the suppliers. The most critical audit points are: source of Gelatin used, quality control and quality assurance procedures, packaging system and storage conditions. In addition to these the facility shall be checked for domestic and international quality certifications and advance quality features.
FORMULATION AND EVALUATION OF FAST DISINTEGRATING LOSARTAN POTASSIUM TABLETS BY FORMAL EXPERIMENTAL DESIGN
Authors: Birajdar Shivprasad M. , Bhusnure Omprakash G. , Mulaje Suraj S.
Published: July 2018

In the treatment of hypertension fast onset of action is the major concern. The problem of slow onset of action of drugs can be overcome by development of appropriate dosage forms. Fast disintegrating tablets in mouth are best suited and have gained popularity in the oral antihypertensive drug therapy. These are advantageous over other conventional systems in terms of patient compliance, rapid onset of action, accurate dosing, good chemical stability, convenience of self-administration and compactness. Losartan potassium is widely used as an antihypertensive drug, which is a potent drug candidate for developing in to Fast Dissolving Tablets (FDT’s). It has low bioavailability due to first pass metabolism. Hence the main objective of the study was to formulate fast dissolving tablets of Losartan potassium to achieve a better dissolution rate and further improving the bioavailability of the drug. Fast dissolving tablet of Losartan potassium were formulated by using microcrystalline cellulose with different concentration of super disintegrants like sodium starch glycolate and Isabgol Mucilage. All the batches were prepared by direct compression.

API characterization studies were conducted to check the purity of API .The tablets were evaluated for Pre compression parameters and post compression parameters. Before the formulation of the tablets IR spectroscopic studies were also performed to check the compatibility with the excipients.

A 23 full factorial design was applied to investigate the combine effect of 3 formulation variables. Here the concentration of Isabgol mucilage, concentration of Sodium Starch Glycolate and concentration of Microcrystalline Cellulose were taken as independent variable X1, X2   & X3   respectively and their effect of disintegration time is studied as dependent parameter. To represent the data Design Expert software is used.
SYNTHESIS AND CHARACTERIZATION OF A NOVEL BONE GRAFT MATERIAL CONTAINING BIPHASIC CALCIUM PHOSPHATE AND CHITOSAN FORTIFIED WITH ALOE VERA
Authors: Srividya S. , Sastry T. P. , D. Jeevitha , N. Samiksha
Published: July 2018

The bone grafts were prepared using nanohydroxyapatite (nanoHAP) with the extracts of AV and mixed with beta tricalcium phosphate (βTCP) in a ratio of 60:40. The formed BCP was then conjugated with CH to form the bone graft. The Phytochemicals of AV imparts an anti-inflammatory and wound healing property to the bonegraft in addition to its osteoconductivity.

The bone graft was subjected to various conventional characterization techniques like FTIR, XRD, SEM, UV spectrophotometric analysis, compression and tensile strength to reveal its chemical composition, surface morphology and mechanical strength. The UV spectrophotometric analysis and SEM images revealed the mineral deposition on the bone graft after immersing in SBF, thereby increasing its ossification property. FTIR and XRD revealed the presence of BCP with nano HAP crystals and Chitosan in the graft. Compression and tensile strength of the graft showed that the graft can be used in non–load bearing areas.

In this study, a bone graft was synthesized using a novel technique of introducing the extracts of AV in the graft along with BCP and CH. The results revealed that the bone graft can be used as an Osteoconductive material for various biomedical applications.
INTERNATIONAL CONFERENCE ON HARMONISATION: AN OVERVIEW
Authors: Kolla Chaitanya Prasad
Published: July 2018

The International Conference on Harmonisation (ICH) is a project that makes together the regulatory bodies of Europe, Japan and the United States and professionals from the pharmaceutical domain in the three areas to discuss scientific and technical views of medicinal product registration. The one aim of ICH is to reduce the need to repeat the testing carried out during the R &D of new Pharmaceuticals by suggesting ways to attain greater harmonisation in the interpretation and application of technical guidelines and requirements for Pharmaceuticals registration. Harmonisation would lead to a more frugal use of human, animal and material resources, and the evacuation of unnecessary time lag in the global development and availability of new Pharmaceuticals while maintaining safeguards on quality, safety, and efficacy, and regulatory duties to protect public health.
PIC/S: TRAINING THE REGULATORS TO REGULATE cGMP COMPLIANCE
Authors: Gupta Rajkumar
Published: July 2018

PIC/S is an international Organization for implementing cGMP standards in its member countries. The basic objective of PIC/S is to improve and standardize cGMP compliance in member countries. Their aim is to enhance GMP intelligence via sharing of GMP inspection reports. Further it wants to reduce duplication of inspections to save the cost and time.

Their regulations are directed to promote harmony in GMP standards and to train national regulatory authorities for cGMP vigilance. They requires that every nation shall empower the legislation to inspect the facilities as per definite program, to issue notices for noncompliance, to impart regular training to all concerned employees.
REVIEW ON OCULAR DRUG DELIVERY SYSTEM AND ITS DEVICES
Authors: Gulati Nikhil , Dwivedi Vanya
Published: July 2018

Ocular drug delivery system for the treatment of eye diseases has become popular and feasible in the past few years. Improving ocular contact time, enhancing corneal permeability and site specificity are the key points for the optimization of ocular drug delivery. Use of polymers such as ethylene vinyl acetate copolymer can increase the solution viscosity and decrease the drainage of solution, thereby increasing the contact time and its bioavailabilty. There are various types of ocular drug release system such as ocusert, contact lenses, diffusional inserts which falls under the category of non-erodible ocular controlled release system, lacrisert, soluble ocular delivery implant(SODI), minidisc which falls under the category of erodible ocular controlled release system; nanoparticles; liposomes.

Episcleral, intrascleral and suprachoroidal routes have the advantage of bypassing the main barriers to topical drug penetration. This type of delivery system provides a controlled release of drug for a long period of time. This type of delivery system has good patient compliance. Acuvue, lacrisert; biomedics are the most common marketed products of ocular drug delivery system.
RISK DRIVERS OF FALSIFIED AND SUB-STANDARD MEDICINES IN EAST AFRICA: PERCEPTIONS AND PRACTICES OF PHARMACEUTICAL DRUG FACILITY OWNERS/EMPLOYEES
Authors: Fomundam Henry , Tesfay A , Maranga A , Oyaro F , Kambafwile H
Published: July 2018

An interview survey was conducted among drug shop owners to investigate the access to and perception ofcounterfeit medication along transport corridors of East Africa spanning Kenya, Tanzania, Uganda and DemocraticRepublic of Congo. Owners of 171 retail drug outlets of modern medicines were interviewed on their knowledge,perception, and practices related to counterfeit medicines. Forty-four (44) encounters with counterfeit medicines werereported. Twenty-two (22) of the 171 interviewed drug store owners said that quality was the least important aspectthey considered when procuring drugs. Generally, 65.9% of the drugs were sourced from registered wholesalers anddistributors while the remaining 34.1% were supplied by unregistered in-country or cross-border sales representatives.In all the four countries, the 10 fastest moving drugs were reported to originate from 27 different countries with most(39%) from India. From 171 interviewees, 135 acknowledged that they were aware of the existence of counterfeitdrugs, 106 of whom attributed their level of awareness to mass media. Only 32 of the interviewees reported havingreceived any formal training on counterfeit medicines at seminars or workshops. 160 of the intervieweesacknowledged that counterfeit drugs pose a major threat to the patient and pharmaceutical market. The region has aplethora of drug outlets run by attendants with varying backgrounds, diverse knowledge on medicines and practicepatterns. There is an urgent need for medicine regulators and other stakeholders in Africa involved in medicine safety,to focus on properly regulating these outlets and also standardizing and training the drug outlet personnel.
QUALITY STANDARDS FOR MEDICAL DEVICES
Authors: Jain Achin , Ganesh Neenu , Venkatesh M. P.
Published: July 2018

Formerly with more augmented disabilities, Medical devices have become decisive device in many circumstances. As these are more perilous, the manufacturer should endow with an ideal medical device in aspects of safety & quality. To produce a homogeneous device globally, there should be some standards to be followed within an explicit country and standard throughout the globe, complying with the quality. In milieu of this resemblance of device globally, International Organization for Standard (ISO) has issued a standard, ISO 13485. This article is made to furnish the details about ISO 13485 and the Quality management system followed by United States manufacturer’s to market their devices within the country, i.e., 21 CFR Part 820.
REVIEW OF MARKETING AUTHORIZATION OF MEDICAL DEVICES IN INDIA
Authors: Gupta Rajkumar M.
Published: July 2018

Marketing authorization of medical devices in India is given under heading “Registration Certificate and it is as per the regulatory processes in other countries. The foreign companies marketing of medical devices require either own office or an agent to receive, store and distribute the devices. The marketing Authorization (Registration Certificate) is considered valid for three years from the date of its issue. Only the Notified Medical Devices, New medical Devices and the devices classified under drug rules require marketing Authorization from DCGI. The other medical devices e.g. Non-notified devices do not require manufacturing, sales, import registration and can be marketed freely.
REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND
Authors: Jain Achin , P. Venkatesh M. , Reddy.G Raja Mohan , T.M. Pramod Kumar
Published: July 2018

The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved for marketing simultaneously in different countries. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of medicines in their country. It not only includes the process of regulating and monitoring the drugs, but also the process of manufacturing, distribution, and promotion. The regulatory environment has similar characteristics, but drug registration requirements and processes differ among the countries. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. In ASEAN region, documentation can be filed in the ACTD format. Even though ACTD format is mandatory from 2009, the member countries have their own requirements for registration process like administrative documents, labeling. The purpose of this paper is to give a comparative overview on the Drug regulatory requirement for generics in two of the ASEAN countries which are Singapore and Thailand.
EMERGENCY USE AUTHORIZATION: AT ZERO HOUR
Authors: Balamuralidhara V. , A.M. Vaishnav , V. Bachu , T.M. Pramod Kumar
Published: July 2018

The Emergency Use Authorisation (EUA) authority plays a vital role in US FDA. They provide the authority/permission to use the unregistered products/registered product with unregistered route to treat the life threatening damages to the patients in world in some emergency conditions. The aim of this work is to give an overview on EUA in life threatening conditions and there challenges in getting the permissions under regulations with example of E-bola virus. The e-bola is a virus. It is a hemorrhagic fever deadly disease caused by one of the E-bola viral strain, which is wide spread in West Africa. The -Secretary of the Department of homeland security (DHS), determined, pursuant to section 319F-2 of the Public Health Service Act, that the Ebola virus presents a material threat against the United States population sufficient to affect national security. Issuance of EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. The FDA Commissioner, can only issue the EUA, if criteria for issuance under the statute are met. This study’s highlights the importance of the EUA in emergency when there is no medicine for disease/virus in the world. For example the FDA has issued a EUA to use the ReEBOV which is the Rapid Antigen Test device designed by Lusys lab co. Pvt. Ltd. for detecting the Zaire Ebola virus.
Projekcja opłacalności uprawy zbóż w Polsce w 2022 roku na tle prognozy produkcji zbóż w Unii Europejskiej do 2030 roku
Authors: Skarżyńska Aldona , Pietrych Łukasz
Published: July 2018

Celem badań było określenie wpływu prognozowanej zmiany cen środków do produkcji rolnej, plonów oraz cen sprzedaży produktów na opłacalność uprawy pszenicy ozimej, żyta ozimego i jęczmienia jarego w 2022 roku. Rezultaty badań wskazują na poprawę wyników produkcyjnych i cenowych badanych zbóż. Stwierdzono, że najsilniejszy wzrost przychodów odnotują producenci żyta. Zbadano również zakres odchyleń od wyników projekcji zbóż, ze względu na jednostkowe zmiany plonu, ceny i kosztów uprawy. Wyniki wskazują, że żyto i jęczmień jary charakteryzuje dość duża wrażliwość na każdy z czynników dochodotwórczych, natomiast w przypadku pszenicy ozimej siła ich oddziaływania jest słabsza. Postępujące procesy integracji powodują, że tego typu rozważania należy prowadzić z uwzględnieniem przewidywanych zmian na rynku unijnym. W związku z tym wyniki zaprezentowano na tle zmian jakie do 2030 roku przewiduje Komisja Europejska.
Tendencje na rynku mleka na świecie i w Polsce w latach 2000 2016
Authors: Stańko Stanisław , Mikuła Aneta
Published: July 2018

Opracowanie przedstawia zmiany w produkcji mleka na świecie w latach 2000-2016. Przedstawiono zmiany ogółem oraz u największych producentów. W badanych latach produkcja mleka ogółem zwiększała się przeciętnie w roku o 15 mln ton, tj. w tempie 2,18%. W 2016 r. udział mleka krowiego w produkcji wynosił 82,6%, bawolego 13,9%, a mleka koziego, owczego i wielbłądziego wynosił 3,4%. Zmiany produkcji u największych producentów mleka były zróżnicowane co do kierunków i skali. Zróżnicowane były również kierunki zmian zużycia krajowego mleka. Na tej podstawie wyodrębniono trzy grupy krajów: o rosnących nadwyżkach rynkowych, o rosnących niedoborach rynkowych i o spadających nadwyżkach rynkowych mleka. W największej skali rosły nadwyżki rynkowe mleka w USA, Nowej Zelandii i krajach UE. Z tych krajów w 2016 r. pochodziło prawie 80% światowego eksportu mleka i jego produktów. W mniejszej skali nadwyżki rynkowe zwiększały się także w Argentynie i Turcji. Rosnące niedobory rynkowe mleka i jego produktów w największej skali występowały w Chinach i Rosji, a także w mniejszej skali w Meksyku, Brazylii i Pakistanie. Tendencja spadkowa w nadwyżkach rynkowych występowała w Australii, Ukrainie a także w Indiach. Polska charakteryzowała się rosnącymi nadwyżkami rynkowymi mleka i jego produktów, co powodowało wzrost eksportu. Na rynkach zagranicznych niezbędne było zagospodarowanie 2/3 przyrostu produkcji mleka w Polsce.
The Use of CSR Measurement Matrix in the Aspect of Sustainable Development
Authors: Klepacka Anna , Bagińska Monika
Published: July 2018

The idea of Corporate Social Responsibility (CSR) represents the voluntary effort that companies invest in social life. Companies incorporate the concept of CSR strategy in their businesses, knowing its importance to the benefit of the public at large and to sustainable development. Any activity of any major company is exposed to public opinion, which plays a key role in shaping the image of the company. Companies compete to win social trust and acceptance of their activity. The aim of the article was to present the value and significance of CSR activities undertaken by companies, using the example of two businesses, i.e. Polski Koncern Naftowy (PKN) Orlen and Kompania Piwowarska in reference to sustainable development. The article compares the CSR measurement matrix that allows assessing whether a given company is socially responsible, to what extent CSR activities affect the company's stakeholders and to what extent they are consistent with sustainable development (assigning particular CSR development tools by Stakeholders applying the weights from 1 to 3). ISO 26000 standards define the principles of social and environmental responsibility as a guide for organizations and in the analysed companies are a tool that exerts one of the greatest impacts on stakeholders. For both companies, the most important stakeholders are Shareholders and Managers, and they are the ones who, to the largest extent, conduct a socially responsible dialogue for which all CSR development tools are important. Both companies conduct key activities, PKN Orlen used 91% and Kompania Piwowarska 73% of all CSR development tools considered in this study.
General helices with lightlike slope axis
Authors: Camcı Çetin , İlarslan Kazım , Uçum Ali
Published: July 2018

In this paper, we investigate general helices with lightlike slope axis. We
give necessary and sufficient conditions for a general helix to have a
lightlike slope axis. We obtain parametric equation of all general helices
with lightlike slope axis. Also we give a nice relation between helix with
lightlike slope axis and biharmonic curves in Minkowski 3-space E31.
Soliton solutions for (2+1) and (3+1)-dimensional Kadomtsev-Petviashvili-Benjamin-Bona-Mahony model equations and their applications
Authors: Tariq Kalim , Seadawy Aly
Published: July 2018

The Kadomtsev-Petviashvili-Benjamin-Bona-Mahony (KP-BBM) model equations as
a water wave model, are governing equations, for fluid flows, describes
bidirectional propagating water wave surface. The soliton solutions for
(2+1) and (3+1)-Dimensional Kadomtsev-Petviashvili-Benjamin-Bona-Mahony
(KP-BBM) equations have been extracted. The solitary wave ansatz method are
adopted to approximate the solutions. The corresponding integrability
criteria, also known as constraint conditions, naturally emerge from the
analysis of the problem.
Complete Heyting algebra-valued convergence semigroups
Authors: Ahsanullah T.M.G. , Al-Thukair Fawzi
Published: July 2018

Considering a complete Heyting algebra H, we introduce a notion of stratified
H-convergence semigroup. We develop some basic facts on the subject, besides
obtaining conditions under which a stratified H-convergence semigroup is a
stratified H-convergence group. We supply a variety of natural examples; and
show that every stratified H-convergence semigroup with identity is a
stratified H-quasiuniform convergence space. We also show that given a
commutative cancellative semigroup equipped with a stratified H-quasi-unifom
structure satisfying a certain property gives rise to a stratified
H-convergence semigroup via a stratified H-quasi-uniform convergence
structure.
Crecimiento del robalo y el chucumite en agua dulce en el estado de Veracruz, México / Growth of the snook and chucumite in fresh water in the state of Veracruz, Mexico
Authors: Zarza Meza Eduardo
Published: July 2018

México cuenta con 1.5 millones de hectáreas de aguas protegidas y con características apropiadas para llevar a cabo el cultivo de diversas especies de peces marinos, entre las cuales se encuentran la Centropomus parallelus, conocido localmente como chucumite, y la Centropomus undecimalis, también llamado como robalo; ambas se distribuyen en la costa atlántica del continente americano, desde el extremo sur del estado de Florida, Estados Unidos, hasta el sur de Brasil.Considerando el potencial para realizar las actividades de cultivo de estas especies en el estado de Veracruz, México, se llevó a cabo el presente estudio, el cual tuvo la finalidad de evaluar el crecimiento de ambas especies en estanques rústicos de tierra y de concreto.Así, en ambos tipos de estanques se introdujeron crías de robalo y chucumite en una proporción de 3:2, durante un periodo de 14 y 12 meses, respectivamente, alimentándolos con especies forrajeras como la tilapia y los poecílidos.En ambos casos, el crecimiento fue isométrico y el índice de mortalidad fue de 10 %, por lo que se arribó a la conclusión de que el cultivo del robalo y del chucumite puede desarrollarse en cautiverio en estanques de agua dulce tanto de tierra como de concreto, incluso colocando ambas especies de forma conjunta.
A NEW DEAL BETWEEN DEMOSES AND THEIR ELITES NECESSARY TO SAVE EUROPE
Authors: WĘGRZECKI Janusz
Published: July 2018

The article focuses on social, political and cultural evolution in Europe. It describes and interprets the deepest – cultural – cause of observing social and political changes. It analyses gradually a picture of the new demos and the elite that is beginning to emerge. It compares the ideological character of these demoses and elites. Previous one, his ideological character is democratic-liberal-leftist. Later one, his character is democratic-liberal-right. It analyses the new demos and new elite democratic-liberal-right that come in the political stage in EU. It proposes a new deal between both of demoses and elites necessary to save political peace in EU. If EU could survive it needs be a new deal between left and right attitude. Europe needs a new consensus to establish new rules of a law-governed state, establish new values as liberal-left-right and establish new form of democratic state as liberal-left-right democratic.
VISEGRÁD FOUR OR GERMAN EUROPE TWO FICTIONAL STRESS TESTS ON AND FOR CENTRAL EUROPE
Authors: GONĚC Vladimír
Published: July 2018

Contrast going on for decades: after old concepts of economic and political integration of central Europe, there has been a shift to the acceptance of the thesis that Central Europe is only a cultural area. After 1968, the mental direction switched to Austria and old Bundesrepublik which should play central role in complex restoration of Central Europe. New start after 1989, present situation and perspectives: V4 as an illusion and organisation verging on inefficiency from the beginning. Hardly perceived deep differences between individual V4 countries. Mental relations to the Great Britain as naive ideas or results of anti-German resentiment. Expected consequences of brexit for V4 countries. Actual relations and connections between economies of V4 countries and Germany and their strengthening. Political relations between Germany and the V 4 countries. New activities of Austria in Central Europe. Austerlitz Triangle in cohesion of Central Europe; France and the Austerlitz Triangle. Currency euro in Central Europe. Migration or invasion? Experiences with the integration of migrants and failed integration of other migrants in Central Europe. Perspectives of Central Europe in EU.
BORDERS AND BORDER REGIONS IN EUROPE – EUREGIOS AS A MODEL OF CROSS-BORDER CO-OPERATION FOR EAST-CENTRAL EUROPE?
Authors: HIEPEL Claudia
Published: July 2018

The present article deals with forms of cross-border co-operation that were established along the Dutch-German borders since the 1950s. They were testing grounds for new regional forms of governance and consolidated as one level within the European multi-level governance system. These so-called Euro-Regions also served as model in East-Central Europe after the collapse of the Communist system. The article intends to show similarities and differences between these traditional Euro-Regions and the later foundations in Eastern border-regions. It also aims to shed light on their potential to stabilize the system of open borders within the EU.
Key aspects of raising efficiency of management of equipment maintenance and repair in fuel and energy complex companies
Authors: Kamko Y. A.
Published: July 2018

Transition to a new industrial revolution (“Industry 4.0”) in power engineering has stimulated introduction of advanced efficient equipment through modernization of existing or construction of new power units. At this stage, production processes are now characterized by deep integration of information technologies. This does not only apply to the processes of financial and economic acivities, but also the processes of providing up-to-date information on the current state of equipment, various supporting systems (security, fi re safety, movement control, work progress control, etc.) for making decisions in real time, as well as predictive analytics.

Raising the efficiency of management of equipment maintenance and repair is a top priority issue. The proper setup of this process does not only determine the quality and operability of equipment, but also the accuracy of evaluation of expenditure, which eventually affects the company’s financial standing. Therefore, the author is set to analyze the causes preventing efficient implementation of the process of equipment maintenance and repair at fuel and energy complex companies and suggests measures for their possible adjustment.

Key aspects are formed, which enable the organizations involved to get closer to more accurate formation of repair and maintenance operations.

Measures are presented that enable to create and develop a proper working system for the management of maintenance and repair measures. In particular, logical blocks are specified for implementation of a data management system in maintenance and repair.
Methodological aspects of assessment and forecast of technical condion of the main installed equipment of power plants
Authors: Rimov A. A.
Published: July 2018

The methodology is presented for assessment of the technical condition of an object, which is a separate unit of power equipment from a group of the same type of equipment of power plants. It is demonstrated that technical condition is a characteristic of quality of an object under investigation, which, for practical purposes, should be calculated as a deviation from an established value. The assessment of technical condition is fulfilled with uniform criteria based on a limited amount of initial data on each of the basic properties of the object. The assessment can be fulfilled at the level of the object performance indicator, at the level of the object individual property and at the level of a set of the object properties. The top level assessment is a function of the loss of quality by the object, which is calculated through convolution of low level values. The assessment of technical condition of an object is accompanied by calculation of uncertainty of quality loss functions by means of transformation of uncertainties of initial data into uncertainties of output values. The evaluation of the technical condition can be expressed either in relative units - the percentage of quality loss relative to the maximum possible quality of the object, or in absolute units - the monetary equivalent of a loss of quality by the object. Evaluation in relative units enables to determine the residual gamma resource of the object, but this requires the participation of an expert to assign the weight of performance indicators. Evaluation in absolute units makes it possible to identify objects whose improvement in technical condition is appropriate from the economic point of view. To track the reasons for deviations in the technical condition from the set values, a structured list of performance indicators and factors affecting them is used. It is shown that the possibilities of evaluating the technical condition in relative units are limited: an attempt to perform assessment and analysis of the technical condition by convolving values of indicators and characteristics of properties into a single numerical index gives incorrect results. Neglect of these restrictions leads to emergence of inadequate, unsubstantiated scientifically methodological requirements for assessment of the technical condition of power equipment.
Opmizaon of work on taking gas samples from transformer gas relays
Authors: Vysogorets S. P.
Published: July 2018

Quality taking and analysis of gas and oil samples upon actuation of gas protection is an essential component of transformer operation, in making a prompt decision on its admissibility to operation after an emergency shutdown. Existing conventional systems for taking, storage and transportation of gas samples from gas relays have a number of significant drawbacks. At the same time, the devices in use at present often fail to ensure the representative nature of samples; besides, when used in line with established rules, they are inconvenient in sampling and “combustibility” checks.

To solve the aforesaid problem, a study has been performed at the facilities of the physical-chemical and chromatographic analysis laboratory of the diagnostics directorate of the branch of PJSC “IDGC of North-West” on a number of advanced technologies that could be used for taking, transportation and storage of gas samples. In the experimental study, 0.5 l gastight bags made by SKC (США) (models No.237-02 and No.232-02, differing in the design of the sampling system) and 0.5 l bags made by Elchrom (model EL-PACK G-300) were used. Experimental work on examination of gas-tight bags was carried out in two stages. At the first stage, gas-tightness was assessed at room temperature, and at the second stage, the effect of negative temperatures on gas-tightness was investigated.

In the course of the experimental studies, the feasibilility was confirmed of using advanced Russian and foreign technologies for taking, storage and transportation of gas samples from transformer gas relays. The models of gas-tight bags under investigation are found to be appropriate for taking, storage and transportation of gas samples, both at positive temperatures of the ambient air, and at temperatures as low as minus 15–18°С (the effects of still lower temperatures was beyond the scope of the study). To establish the feasibility of repeated use of gas-tight bags, it is proposed to continue experimental studies.
Entrevista com Marcos Von Sperling
Authors: Frade Paulo Ricardo
Published: July 2018

Entrevistamos o Professor Titular do Departamento de Engenharia Sanitária e Ambiental da UFMG, Pesquisador do CNPq (nível 1A) e Doutor em Engenharia Ambiental pela Imperial College - London, Inglaterra, Dr. Marcos Von Sperling.
Re-Contextualizing Foreign Influence in Japan’s Educational History: the (re)reception of John Dewey
Authors: Rappleye Jeremy
Published: July 2018

This work explores John Dewey's reception and re-reception in the Japanese context. Although Dewey's two month visit to Japan in the spring of 1919 coincided with the hopeful Taishō democracy movement, his ideas appear to have made little impact in a political, intellectual, and educational landscape dominated a complex interplay of traditional neo-Confucian, nativist, and German ideas. Yet the story does not end there: following World War II, there was a remarkable Dewey 'boom' across Japan lasting more than a decade that far surpassed Dewey's original reception in 1919. Here we find Dewey central to revamped reform debates and a focal point for the reinterpretation of Japan's prewar educational history. Given this curious resurgence-cum-paradox of increasing interest in Dewey, few national contexts would seem to hold more evidence than Japan in support of the idea that political and ideological shifts qualify definitions of what counts as educational 'knowledge'.
Diffusion-Reception Networks of Pedagogical Knowledge: The circulation of John Dewey's educational discourse in the Luso-Afro-Brazilian space
Authors: Madeira Ana Isabel
Published: July 2018

This article addresses the question of the appropriation of John Dewey’s pedagogical ideas in relation to the study of communication networks and the thesis of diffusion-reception of educational knowledge in the Luso-Afro-Brazilian space. It aims at the analysis of the interactions that took place between the Portuguese movement known as “Escola Nova,” the Brazilian “Escolanovismo,” and the construction of colonial educational systems, in the early decades of the twentieth century. It tries to assess the results of projects undertaken during the last decade by Portuguese, African, and Brazilian researchers in the field of educational history in a comparative perspective. It tries to set a development axis for comparative-history research in the Lusophone space by identifying the educational transfers between Portugal, Africa, and Brazil. It aims at clarifying John Dewey’s contribution towards the establishment of specialized educational knowledge.
Ruralizing Dewey: The American friend, internal colonization, and the Action School in post-revolutionary Mexico (1921-1940)
Authors: Bruno-Jofré Rosa , Valle Carlos Martinez
Published: July 2018

The article examines how and to what extent the ideas of John Dewey were adopted and adapted by the political and educational elite of post-revolutionary Mexico and the consequences of that adoption. It provides the political, cultural, and socio-economic context of reception as well as the various points of entry of Dewey`s ideas including the relation between the Secretary of Education, the Universidad Nacional de México and Columbia University (in particular Teachers College) and the influence of the Protestant missionaries. The article discusses the issues and ideas that characterized the political and educational debates of the time and mediated the traveling and reception of international pedagogical ideas. It pays particular attention to the building of Mexicanidad (nation building) through the incorporation or the integration (depending on the dominant current thought) of the rural and indigenous population in a contradictory and eclectic modernizing project. It does not neglect the negative consequences of the translation of some progressive ideas. The introduction of Dewey`s ideas are discussed within the context of the various political and educational tendencies inside the Secretary. The last part of the paper is devoted to Rafael Ramírez, a progressive educator, a central protagonist, who served in the Secretary for a long time in spite of political changes and who devoted his life to rural education and its civilizing mission. He wrote about education and we can trace his reading of Dewey.