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Chakrapani Balijepalli,1 Lakshmi Gullapalli,1 Eric Druyts,1 Kevin Yan,1 Kamal Desai,1 Stephane Barakat,2 Jason Locklin2 1Pharmalytics Group, Vancouver, British Columbia, Canada; 2Alexion Pharmaceuticals, Vaughan, Ontario, CanadaCorrespondence: Chakrapani Balijepalli Email chak.balijepalli@pharmalyticsgroup.comAbstract: Orphan drugs have high acquisition costs and when standard health technology assessment (HTA) approaches are used to assess their cost-effectiveness, they often appear not cost-effective. The Canadian Patented Medicine Review Board (PMPRB), through new regulations, will apply HTA assessment results from the Canadian Agency for Drugs and Technologies in Health (CADTH) and Institut national d’excellence en santé et en services sociaux (INESSS) when setting the maximum price that can be charged for Category I patented medicines (treatments with an annual cost exceeding 150% of GDP per capita of Canada or with expected annual market size >$50M). Through these regulations, PMPRB has also established a willingness-to-pay threshold of CAD$200,000 or CAD$150,000 per quality adjusted life year (QALY) for medications with a prevalence of no more than 1 in 2000 across all approved indications. We reviewed the orphan drug submissions made to CADTH’s Common Drug Review (CDR) January 2015–May 2020 to understand how the methodology of assessing cost-effectiveness of orphan drugs has guided pricing in Canada. A total of 35 orphan drug submissions were assessed by CDR in this period, none of which met the willingness-to-pay threshold of CAD$50,000 per QALY. Only one drug met the CAD$200,000 per QALY for Therapeutic Criteria Level I, and two drugs met CAD$150,000 per QALY for other Therapeutic Criteria Levels proposed by PMPRB. Price reductions of 32– 99% were recommended for treatments that were approved in order to be listed for reimbursement. This review showed that the new PMPRB regulations could be creating challenges for manufacturers of rare disease treatments to meet Canadian pricing regulations. These regulations may jeopardize the launch of new medicines and limit opportunities to add to the development of real-world evidence of orphan drugs, which can be used in reimbursement approaches such as pay-for-performance.Keywords: orphan drugs, rare diseases, CADTH, QALY, HTA

Fifty-four growers/producers attended four 1-day good agricultural practices (GAP) and good handling practices (GHP) workshops at four locations in Mississippi. Pre- and post workshop survey data indicated that the participants' food safety knowledge increased by 15%. Furthermore, the workshops helped producers develop their own food safety plans. The workshops also trained the producers to be prepared for U.S. Department of Agriculture (USDA) GAP and GHP audits. To assist producers in preparing for these audits, two mock audits were conducted after the workshops. As a result of the program, several producers became ready to be audited, and at least one producer became USDA GAP certified.

nacks was made from yellow corn and its blends had contained corn, barley, chickpea, cumin, black cumin, black pepper and lettuce seeds at different levels considerable as lettuce seeds of ingredient and products were defined as physical, chemical and sensory evaluation. The results showed that the chickpea had contained the highest in protein and total lipids 40.60 and 15.50%. The black pepper, chickpea and cumin seeds had contained higher in crude fiber (14.20, 10.71 and 10.50%, respectively). The snacks with lettuce seeds showed that the protein was the highest in group (2) it was 15.04, 16.44 and 17.82 %. Total lipids, crude fiber and ash content were decreased gradually in the snacks from group (1) 4.02, 4.87 and 5.72% and the highest in total lipids in group (2) which contained 4.23, 5.08 and 5.93%, respectively. Hunter color values of snacks control and its different blends from lettuce seeds the group (6) prepared with 60% corn grits and 15, 10 and 5% barley and also 6% lettuce seeds showed that higher in lightness and yellowness till 15% chickpea and nearly control snacks. The highest (WAI) and (WSI) were in groups (1 and 2) respectively made from 40% corn grits and 40, 35, 30 and 25% barley. The sensory properties showed that the extrusion blend (18) made from 20% chickpea and 5% barley the highest acceptability (95%) and nearly control (96%) followed were by 10 and 15% chickpea plus 15 and 10% barley were gave 93.0 and 88.0% during overall acceptability.

Ninety-seven spices of seven different types were collected from different retailers in the West Bank of Palestine and were analysed for fungal contamination, specifically aflatoxigenic Aspergillus spp. and Aflatoxin B1 (AFB1) levels. Aspergillus was found in 89% samples analysed. Ground red chilli had the highest average number of fungal colonies. In decreasing order, mixed spices (57%), cardamom (53%), red chilli (52%), chicken spices (50%), sumac (47%) and pepper (38%), were contaminated with Aspergillus species. Aspergillus niger and A. flavus were dominating Aspergillus species in 37% and 23% of food samples analysed, respectively. Of the 11 tested isolates, 82% were identified as aflatoxin-producers. AFB1 was detected in 40.2% of the samples analysed with a mean value of 2.09 ± 3.20 μg/kg. Red chilli powder followed by chicken spices and cardamom recorded the highest levels (6.98, 3.55 and 1.48 μg/kg, respectively). Twenty-two of the spices (23%), were above the European Union's maximum limit of 5 μg/kg. [ABSTRACT FROM AUTHOR]

The objective of the present study was to detect and quantify aflatoxins in liver and milk of camels. HPLC method was used to detect different aflatoxins. Liver samples were collected from slaughterhouses and milk samples from breeder's sites in Eastern Province, Saudi Arabia. Samples of camel livers and milk (250 samples of each) were collected and analyzed. About 26.4 and 16% of livers showed a contamination level in the range of 0.4-1 ng/g aflatoxin B1 and B2, respectively, but there were no detectable levels of G1, G2, M1 and M2. About 29.7% of milk samples had a range of aflatoxin M1 of 15-50 ng/l and 6% had a range of 50-100 ng/l. However, M2 was not detected in any milk sample. Based on regulatory limits, the present values of aflatoxin in livers and milk were within the internationally accepted limits (permissible limits of aflatoxins are 0.5 ppb for liver and liquid milk, according to the Saudi Organization for Standardization, Meteorology and Quality, (SASO). [ABSTRACT FROM AUTHOR]

Background: Infected nonunion of the distal humerus represents a true challenge as the fragment is usually small and difficult for fixation. The aim of the present study is to assess the results of Ilizarov external fixator in management of infected nonunion of the distal third humerus.Material and Methods: Twenty-three patients with infected nonunion of the distal humerus were included in this study. The ages ranged from 19 to 58 years with an average of 35 years. Seventeen cases were males and 6 were females. All patients were treated by radical debridement and application of Ilizarov external fixator in one stage surgery.Results: Bony union was achieved in all cases. Bone graft was required in 12 patients with hypotrophic nonunion. The external fixation time ranged from 4 to 9 months with an average of 5.6 months. Infection was controlled in all cases without recurrence during the period of follow up. The complications included pin tract infection in 7 cases, radial nerve injury in one case, elbow stiffness in 4 cases and refracture after frame removal in one case.Conclusion: Ilizarov external fixator is effective in management of infected nonunion of the distal humerus. The thin tensioned wires produce good grip in the small or osteoporotic bone fragments. [ABSTRACT FROM AUTHOR]

Summary: The main objective of this paper is to determine the optimal sizing of a biomass and fuel cell micro‐grid. The biomass generator will be utilized as the main source of power generation for the study area, while the fuel cell generator will be used as a backup generator to be used if the biomass generator fails to meet the energy requirements of the study area. In this research, excess energy will be used to produce hydrogen which is to be used by the fuel cells to generate energy instead of using batteries. To achieve the goal of this paper, a multi‐objective particle swarm optimization (MOPSO) technique has been proposed to solve the sizing problem for the introduced micro‐grid via an economical perspective which is the cost of energy (COE). The MOPSO algorithm tries to mitigate the COE to the lower values by keeping the loss of power supply probability (LPSP) as minimal as possible. Likewise, statistical analysis has been concluded to study the accuracy of the outcomes of the introduced technique. Three indicators have been offered, which are the process capability indices, the normal probability, and the control chart. The final contribution of the consequences of the two presented objective functions clears that the algorithm process is under statistical control, stable, and very precise. The optimum system from the economic perspective consists of two biomass gensets, 31 fuel cells, 65 electrolyzers, and 186 H2 tanks with an NPC of $ 2 314 842, COE of 0.335 $/kWh at an LPSP of 1.929%. [ABSTRACT FROM AUTHOR]

Nonreacting swirling flow behavior through a novel double swirl burner has been investigated in this paper using Detached Eddy Simulation (DES) calculations and experimental measurements. The effect of mixing both the swirling flow of the inner jet (primary air or inner swirler) and the swirling flow of the annular jet (secondary air or outer swirler) on the flow structure has been analyzed. Moreover, pressure losses and flow field characteristics have been investigated at different inlet air mass flow rates and combustor diameters. Due to the drawbacks of general pressure loss to predict the pressure drop through high turbulence swirl flow as well as the complex geometry, the time-averaged viscous dissipation field function is used to predict the pressure drop through the burner. This function is based on the relationship between viscous dissipation and pressure losses. DES flow fields are compared with high-speed particle image velocimetry measurements at different inlet air mass flow rates. It is found that there is good agreement between numerical and experimental results, and both the central toroidal recirculation zone and the corner recirculation zone are well captured. In the case of a single inner swirler, the general pressure drop is very high compared to single outer and double swirl generators, and 84% of the inlet air pass through the outer swirler and just 16% of the air pass through the inner swirler in the case of a double burner (partially premixed). The time-averaged viscous dissipation field function is very important to identify the locations that lead to pressure drop inside the burner, which induces to select the appropriate design for the best performance. In addition, it is concluded that the performance of the double swirl burner is more efficient compared with the other two single swirlers in terms of pressure losses and flow structure. [ABSTRACT FROM AUTHOR]

Abstract This research work crucially deals with a techno-economic feasibility study for off-grid solar photovoltaic fuel cell (PV/FC) hybrid systems. The hybrid renewable energy system is investigated for feeding electric to remote areas and isolated urban regions in Egypt. To achieve this goal, all the system equipment are modeled, simulated and the area under study data is gathered. The objective function is formulated depending on the total annual cost (TAC). The Flower Pollination Algorithm (FPA), as an efficient recent metaheuristic optimization method, proposed to estimate the optimum number of both PV panels and the FC/electrolyzer/H 2 storage tanks set mandatory where the least total net present value (TNPV) is reached. The loss of power supply probability (LPSP) is considered to enhance the performance of the proposed design. The effect of the variation of FC, electrolyzer, H 2 storage tanks and the PV power system initial cost on the levelized cost of energy (LCOE) is presented through a comprehensive sensitivity analysis. Through Matlab™ program, the numerical simulation results obtained by the FPA algorithm have been compared to the corresponding outcomes while using the artificial bee colony (ABC) and the Particle Swarm Optimization (PSO) techniques. According to the simulation outcomes analysis, the FPA Algorithm has the less fulfillment time and good rendering between the other algorithms. In addition, the optimum system configuration is acquired using FPA with the optimal hybridization of 27 solar PV, 28 FCs, 58 electrolyzers and 37 H 2 storage tanks for an LPSP and PEE of 1.52% and 4.68% respectively. The system TNPV is $3,244,897 with the LCOE of 0.334 $/kWh. Highlights • Off-Line Hybrid PV/FC System. • Techno-Economic Feasibility Study. • Power Management Strategy. • Urban Regions. • Flower Pollination Algorithm and the Artificial Bee Colony. [ABSTRACT FROM AUTHOR]

The mistakes in the spectrum management have drive to a problem of the scarcity of spectrum, which can be solved through the use of Cognitive Radio (CR) technology. The main concept of CR technology allows unauthorized users (secondary users (SUs))for using the spectrum resources for communication without harm authorized users (primary users (PUs)).The traditional wireless networks, the nodes are connected based on a centralized infrastructure. But in Cognitive Radio Ad Hoc Network (CRAHN) Networks, mobile SUs nodes are connected to each other without a central infrastructure. Routing in CRAHNs is an important and necessary process in CRAHNs. It faces many and various challenges. These challenges include PUs intervention, frequently dynamic topology, energy consumption problems, unavailable channels, and fragile connections between nodes. The our probased routing protocol called A tree routing protocol for cognitive radio network (C-TRP) has utilized the tree routing algorithm with a spectrum management module in one routing decision module. In this paper, weevalute a performance of the tree routing protocol (C-TRP) under the influence of the different PUs activity patterns with help of three performance metrics :hop count, the number of CR nodes and number of available channels. The performance evaluation is evaluted using NS-2 simulator. Simulation results confirm that C-TRP outperforms "spectrum-tree based on demand routing protocol for multi-hop cognitive radio networks"(STOD-RP), and Cognitive Tree-based Routing(CTBR) in terms of packet delivery ratio and causes less harmful interference to PR nodes, and also less end-to-end delay in all primary radio nodes activity patterns. [ABSTRACT FROM AUTHOR]

Higher-molecular-weight phthalates, such as di-2-ethylhexyl phthalate, are primarily used as plasticizers to soften polyvinyl chloride products, while the lower-molecular-weight phthalates, such as diethyl phthalate, di-n-butyl phthalate, and butyl benzyl phthalate, are widely used as solvents to hold colour and scent in various consumer and personal care products. The average calculated concentration ranges of di-n-butyl phthalate, Di(2-ethylhexyl) phthalates and Di-n-octyl phthalates in all the samples were 1.43-15.8μg/L, 0.0893-58.3μg/L and 0.107-51.5μg/L respectively. Among the analysed samples, Shaneinah Hamoodeh (yougort syrup) has the highest concentration of di-n-butyl phthalate and local cow milk has the lowest concentration. This may be due to nature of the packaging system during manufacturing in the industry. However, local Camel milk has the highest concentration of Di-n-octyl phthalates compared to Cow milk which has the lowest concentration, Values obtained are within acceptable limits. [ABSTRACT FROM AUTHOR]

In this paper, we propose an efficient distributed channel selection strategy DCSSfor message transmission in multi-hop cognitive radio network, DCSS, sort the available channels and uses them efficiently by speeding up data transfer and increasing reliability in multi-hop cognitive radio networks. The classification is done on the basis of channel free from primary radio users and of lowest channels delay. Through extensive NS-2 simulations, we study the performance of DCSS compared to two related approaches. Simulation results show that our strategy is effective in selecting the best channels for packet transsimion (less primary radio interference) and for highest speed reachability in multi-hop cognitive radio networks. [ABSTRACT FROM AUTHOR]

Antibiotic resistance is a major emerging global public health threat. Farmers in the Khartoum state are believed to misuse antibiotics in animal farming leading to daily exposure to resistant bacteria and antibiotic residues. Hence, farmers are at potential risk exposure to bacteria, zoonotic infection and toxicity. We hypothesized that farmers' misuse of antibiotics could be due to their ignorance of the importance of optimal use of antibiotics, the potential health hazards and the economical waste associated with antibiotic misuse practices. In the present study, we investigated knowledge and practices among farmers regarding antibiotic use and resistance. For this purpose, a cross-sectional study was conducted in Khartoum state where data were collected from 81 farmers using structured interviews. Data were analysed both quantitatively and qualitatively. Fifty-two per cent of farmers were uneducated or had studied for <6 years. The majority reported antibiotic use for treatment and prevention while only 5% stated use for growth promotion. Antibiotic group treatment for both sick and healthy animals was commonly practiced among most farmers. The most commonly used group of antibiotics was the quinolones, which was reported by one-third. Only 30% of the farmers had heard of antibiotic resistance and provided their definition. Almost half were not aware of the commonly transferred zoonotic infections between humans and animals. The farmers consume 1-2 meals/day from their own farm products. A significant association between low education, poor knowledge of farmers on antibiotic use, antibiotic resistance and zoonotic infections was found. This association may play a vital role in the present practiced misuse of antibiotics. Our findings on farmers' practices could be used as baseline information in defining the gaps related to antibiotic use and resistance in animal farming in Sudan. It can thus serve as a foundation for future interventions. [ABSTRACT FROM AUTHOR]

We present a novel algorithm for the efficient extraction and visualization of high-quality ridge and valley surfaces from numerical datasets. Despite their rapidly increasing popularity in visualization, these so-called crease surfaces remain challenging to compute owing to their strongly nonlinear and non-orientable nature, and their complex boundaries. In this context, existing meshing techniques require an extremely dense sampling that is computationally prohibitive. Our proposed solution intertwines sampling and meshing steps to yield an accurate approximation of the underlying surfaces while ensuring the geometric quality of the resulting mesh. Using the computation power of the GPU, we propose a fast, parallel method for sampling. Additionally, we present a new front propagation meshing strategy that leverages CPU multiprocessing. Results are shown for synthetic, medical and fluid dynamics datasets. [ABSTRACT FROM AUTHOR]

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This paper presents some of the results from an experimental research project on the behavior of extended end-plate connections subjected to moment conducted at the Structural Laboratory of Jordan University of Science and Technology. Since the connection behavior affects the structural frame response, it must be included in the global analysis and design. In this study, the behavior of six full-scale stiffened and unstiffened cantilever connections of HEA- and IPE-sections has been investigated. Eight high strength bolts were used to connect the extended end-plate to the column flange in each case. Strain gauges were installed inside each of the top six bolts in order to obtain experimentally the actual tension force induced within each bolt. Then the connection behavior is characterized by the tension force in the bolt, extended end-plate behavior, moment-rotation relation, and beam and column strains. Some or all of these characteristics are used by many Standards; therefore, it is essential to predict the global behavior of column-beam connections by their geometrical and mechanical properties. The experimental test results are compared with two theoretical (equal distribution and linear distribution) approaches in order to assess the capabilities and accuracy of the theoretical models. A simple model of the joint is established and the essential parameters to predict its strength and deformational behavior are determined. The equal distribution method reasonably determined the tension forces in the upper two bolts while the linear distribution method underestimated them. The deformation behavior of the tested connections was characterized by separation of the column-flange from the extended end-plate almost down to the level of the upper two bolts of the lower group and below this level the two parts remained in full contact. The neutral axis of the deformed joint is reasonably assumed to pass very close to the line joining the upper two bolts of the lower group. Smooth monotonic moment-rotation relations for the all tested frames were observed. [ABSTRACT FROM AUTHOR]

BACKGROUND: Lactose intolerance is the most common disorder of intestinal carbohydrate digestion. Lactobacillus acidophilus BG2FO4 is a strain of lactobacilli with properties of marked intestinal adherence and high beta-galactosidase activity. OBJECTIVE: This study was designed to determine whether oral feeding of Lactobacillus acidophilus BG2FO4 leads to a lactose-tolerant state. DESIGN: We studied 42 subjects with self-reported lactose intolerance and performed breath-hydrogen tests to determine whether they were lactose maldigesters. Subjects with established lactose maldigestion (n = 24) were invited to be randomly assigned to an omeprazole-treated (hypochlorhydric) group or a non-omeprazole-treated group, but 6 subjects chose not to participate. All randomly assigned subjects (n = 18) ingested Lactobacillus acidophilus BG2FO4 twice per day for 7 d and stool samples were collected. Breath-hydrogen tests were performed and symptom scores were recorded at baseline and after lactobacilli ingestion. RESULTS: Lactose maldigestion was established in 24 of 42 subjects (57%) with self-reported lactose intolerance. In 18 lactose-maldigesting subjects, overall hydrogen production and symptom scores after ingestion of Lactobacillus acidophilus BG2FO4 were not significantly different from baseline values. Live Lactobacillus acidophilus BG2FO4 was recovered in stool samples from 7 subjects. CONCLUSIONS: Lactose intolerance is overreported in subjects with gastrointestinal symptoms after lactose ingestion. Treatment of lactose-maldigesting subjects with and without hypochlorhydria with Lactobacillus acidophilus BG2FO4 for 7 d failed to change breath-hydrogen excretion significantly after lactose ingestion. Copyright (c) 1999 American Society for Clinical Nutrition [ABSTRACT FROM AUTHOR]