Search results for: pharmaceutical quality control lab

Authors: Nor Fazlina Iryani Abdul Hamid, Mohamad Khatim Hasan

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Evolution of software quality measurement has been started since McCall introduced his quality model in year 1977. Starting from there, several software quality models and software quality measurement methods had emerged but none of them focused on telecommunication industry. In this paper, the implementation of software quality measurement system for telecommunication industry was compulsory to accommodate the rapid growth of telecommunication industry. The quality value of the telecommunication related software could be calculated using this system by entering the required parameters. The system would calculate the quality value of the measured system based on predefined quality metrics and aggregated by referring to the quality model. It would classify the quality level of the software based on Net Satisfaction Index (NSI). Thus, software quality measurement system was important to both developers and users in order to produce high quality software product for telecommunication industry.

Keywords: software quality, quality measurement, quality model, quality metric, net satisfaction index

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Authors: Hatice Kahyaoglu Sut, Serap Unsar, Seda Kurt

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The aim of this study is to investigate sexual quality of life in women with gynecological cancer. This cross-sectional study was conducted on 37 women with gynecological cancer and 39 control women (in menopausal term) at the Gynecooncology and Menopause Clinics of Trakya University Medical Faculty between January and July 2015. Women who had sexual active and willing to participate in the study filled an information form inquiring socio-demographic characteristics and Sexual Quality of Life Questionnaire-Female (SQLQ-F). Data were analyzed by Mann-Whitney-U test and Kruskal-Wallis test. The average age of the women was 52.7 ± 7.6 (51.2 ± 8.7 in women with gynecological cancer, 54.3 ± 6.0 in controls). The SQOL-F scores in women with gynecologic cancer (60.8 ± 22.4) was lower than controls (63.5 ± 20.7), however, there was no statistically significant difference (p = 0.759). Women with gynecological cancer who had vaginal dryness and pain during sexual intercourse (45.7 ± 21.3) were lower SQOL-F total score than control group (66.0 ± 21.7) (p = 0.014). The SQOL-F scores in women who took chemotherapy treatment (55.7 ± 17.8) were lower than in women who had not chemotherapy treatment (86.8 ± 16.6) (p = 0.005). In conclusion, taking chemotherapy treatment and occurring vaginal dryness and pain complaints during sexual intercourse in women with gynecological cancer reduces sexual quality of life. Therefore, sexual quality of life in women with gynecological cancer should be evaluated, and they should be supported in order to improve their sexual quality of life.

Keywords: gynecological cancer, quality of life, sexuality, women

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Authors: Xuguo Zhang, Jimmy Fung, Kenneth Leung, Alexis Lau

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Fine particulate matter concentrations have been decreasing in the past few years while the ozone concentrations are posing an increasing trend in the Greater Bay Area (GBA) of China. A series of control policies have been released to mitigate the country-wide air pollution, however, how to effectively evaluate the exercised control measures and efficiently reveal potential projected mitigation pathways are still limited. By refining an enhanced air-quality-modeling system, this study provides an account of the air quality assessments from 2019 to 2025 to appraise the air quality results and improvement under designed scenarios for assessing the optimum scope for tightening the Air Quality Objectives (AQOs). The results show that it is doable to tighten the 24-hour AQO for SO2 from the World Health Objective air quality guidelines Interim Targets Level-1 (IT-1) (125μg/m3) to IT-2 level (50μg/m3) with the current number of exceedance allowed (three) remains unchanged. It is also possible to tighten the annual AQO for PM2.5 from IT-1 (35 μg/m3) to IT 2 (25 μg/m3), and its 24-hr AQO from IT-1 (75 μg/m3) to IT 2 (50 μg/m3) with the number of exceedances allowed increased from current nine to 35. Regional cooperation under the development of the GBA cooperation are still needed to be focused and strengthen due to the cross-boundary transport characteristics of the air pollution.

Keywords: air quality attainment, Hong Kong, mitigation policy, chemical transport modeling, sensitivity analysis

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Authors: Abdel Qader Al Bawab, Mohannad Odeh, Rami Amer

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Recently, there has been an increasing interest in innovative business development. Nevertheless, in the pharmacy practice field, there seems to be a gap in perceptions, attitudes, and knowledge about innovation between practicing pharmacists and academia. This study explores this gap and aspects of pharmaceutical innovation in Jordan, comparing pharmacists and last-year pharmacy students. A validated (r2 = 0.74) and reliable (Pearson’s r = 0.88) online questionnaire was designed to assess and compare knowledge, attitude, and perceptions about pharmaceutical innovation. A total of 397 participants (215 pharmacy students and 182 pharmaceutical professionals) responded. Compared with 50% of the pharmacists, only 32.1% of the students claimed that they knew the differences between pharmaceutical innovation, discovery, invention, and entrepreneurship [x2 (2) = 14.238, p = 0.001; Cramer’s V = 0.189]. Pharmacists demonstrated a higher level of trust in the innovative website design for their institution compared with students (25.3% vs. 16.3%, p < 0.001, Cramer’s V = 0.327). However, 60% of the students did not know the innovative design standards for websites, while the corresponding percentage was 37% for the pharmacists (p < 0.001; Cramer’s V = 0.327). The majority of the students were interested in pharmaceutical innovation (81.9%). Unfortunately, 76.3% never studied innovation in their pharmacy curricula. Similarly, most pharmacists (76.4%) considered adopting innovation, but only 30% had a concrete plan. For the field where pharmacists aim to innovate in the next 5 years, new pharmaceutical services were the dominant field (34.6%). Despite a positive attitude and perception, pharmacists and pharmacy students expressed poor knowledge about innovation. Policies to enhance awareness about innovation and professional educational tools should be implemented.

Keywords: pharmacy, innovation, knowledge, attitude, practice

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Authors: T. Mohammed Chikouche, K. Hartani

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In order to solve the instantaneous power ripple and achieve better performance of direct power control (DPC) for a three-phase PWM rectifier, a control method is proposed in this paper. This control method is applied to overcome the instantaneous power ripple, to eliminate line current harmonics and therefore reduce the total harmonic distortion and to improve the power factor. A switching table is based on the analysis on the change of instantaneous active and reactive power, to select the optimum switching state of the three-phase PWM rectifier. The simulation result shows feasibility of this control method.

Keywords: power quality, direct power control, power ripple, switching table, unity power factor

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Authors: Benchalak Muangmeesri

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The purpose of this paper is to discuss how to test the best control performance of a ceramics. Hydraulic press machine (HPM) is the most common shaping of advanced ceramic with products, dimensions, and ceramic products mainly from synthetic powders. A microcontroller can be achieved to control process and has set high standards in the shaping of raw materials in powder form. HPM was proposed to develop a position control system that linked to the embedded controller PIC16F877 via Proportional and Derivative (PD) controller. The model is performed using MATLAB/SIMULINK and the best control performance of an HPM. Finally, PD controller results, showing the best performance as it had the smallest overshoot and highest quality using a microcontroller control.

Keywords: ceramics, hydraulic press, microcontroller, PD controller

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Authors: Taruna Katyal Arora, Geeta Kumari, Hari Shankar, Neelima Mishra

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Substandard and counterfeit antimalarials is a major problem in malaria endemic areas. The availability of counterfeit/ substandard medicines is not only decreasing the efficacy in patients, but it is also one of the contributing factors for developing antimalarial drug resistance. Owing to this, a pilot study was conducted to survey quality of drugs collected from different malaria endemic areas of India. Artesunate+Sulphadoxine-Pyrimethamine (AS+SP), Artemether-Lumefantrine (AL), Chloroquine (CQ) tablets were randomly picked from public health facilities in selected states of India. The quality of antimalarial drugs from these areas was assessed by using Global Pharma Health Fund Minilab test kit. This includes physical/visual inspection and disintegration test. Thin-layer chromatography (TLC) was carried out for semi-quantitative assessment of active pharmaceutical ingredients. A total of 45 brands, out of which 21 were for CQ, 14 for AL and 10 for AS+SP were tested from Uttar Pradesh (U.P.), Mizoram, Meghalaya and Gujrat states. One out of 45 samples showed variable disintegration and retension factor. The variable disintegration and retention factor which would have been due to substandard quality or other factors including storage. However, HPLC analysis confirms standard active pharmaceutical ingredient, but may be due to humid temperature and moisture in storage may account for the observed result.

Keywords: antimalarial medicines, counterfeit, substandard, TLC

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Authors: J. J. Vargas, N. Prieto, L. A. Toro

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Control charts are commonly used to monitor processes involving either variable or attribute of quality characteristics and determining the control limits as a critical task for quality engineers to improve the processes. Nonetheless, in some applications it is necessary to include an estimation of efficiency. In this paper, the ability to define the efficiency of an industrial process was added to a control chart by means of incorporating a data envelopment analysis (DEA) approach. In depth, a Bayesian estimation was performed to calculate the posterior probability distribution of parameters as means and variance and covariance matrix. This technique allows to analyse the data set without the need of using the hypothetical large sample implied in the problem and to be treated as an approximation to the finite sample distribution. A rejection simulation method was carried out to generate random variables from the parameter functions. Each resulting vector was used by stochastic DEA model during several cycles for establishing the distribution of each efficiency measures for each DMU (decision making units). A control limit was calculated with model obtained and if a condition of a low level efficiency of DMU is presented, system efficiency is out of control. In the efficiency calculated a global optimum was reached, which ensures model reliability.

Keywords: data envelopment analysis, DEA, Multivariate control chart, rejection simulation method

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Authors: Fatemeh Ghaemi, Padideh Feyzi, Zohreh Dortaj

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Cancer is one of the common diseases that may cause death due to malignancy. The physical problems of cancer patients can have an impact on the psychological and social aspects of their lives. Depression is one of these problems that threaten the lives of these patients and can also reduce their quality of life. Helping patients with cancer to find meaning in life can increase their level of health and improve their quality of life. This study thus examines the effectiveness of group logotherapy on the depression and quality of life of women with cancer. Depression was measured using the Beck Depression Inventory (BDI) and quality of life was measured using Quality of Life Questionnaire (WHOQL) with acceptable and reliable indicators in the pre-test and post-test stages. The experimental group received group therapy in eight, sixty-minute sessions and the control group did not receive any intervention. After collecting the questionnaires, the mean and standard deviations were used to describe the data and the statistical method of multivariate analysis of covariance was used at the significant level (P≤0.05). The results were analyzed using SPSS(22). The results showed that there was a significant difference between post-test depression scores in the experimental group and the control group. Also, there was a significant difference between the post-test scores of quality of life and its components (psychological, physical, social and environmental health) in the experimental group and control group. The findings of this study showed the effectiveness of group logotherapy in decreasing depression and improving the quality of life of cancer patients. By focusing the minds of the people on the present and changing the attitude of the human being towards themselves, life and environment can help the depressed people, and by influencing the individual's view of himself, accepting responsibility, accepting life with purpose, paying attention to life uniformly, it allows a person to maintain his quality of life even with cancer. Therefore, it is recommended that this approach be used as a group intervention in hospitals and care units for cancer patients and even in people with certain diseases.

Keywords: cancer, depression, group psychiatry, quality of life

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Authors: Aminu Yakubu Umar

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X-ray is the major contributor to the effective dose of both the patient and the personnel. Because of the radiological risks involved, it is usually recommended that dose to patient from X-ray be kept as low as reasonably achievable (ALARA) with adequate image quality. The implementation of quality assurance in diagnostic radiology can help greatly in achieving that, as it is a technique designed to reduce X-ray doses to patients undergoing radiological examination. In this study, quality control was carried out in six hospitals, which involved KVp test, evaluation of total filtration, test for constancy of radiation output, and check for mA linearity. Equipment used include KVp meter, Rad-check meter, aluminum sheets (0.1–1.0 mm) etc. The results of this study indicate that, the age of the X-ray machines in the hospitals ranges from 3-13 years, GHI and GH2 being the oldest and FMC being the newest. In the evaluation of total filtration, the HVL of the X-ray machines in the hospitals varied, ranging from 2.3-5.2 mm. The HVL was found to be highest in AHC (5.2 mm), while it was lowest in GH3 (2.3 mm). All HVL measurements were done at 80 KVp. The variation in voltage accuracy in the hospitals ranges from 0.3%-127.5%. It was only in GH1 that the % variation was below the allowed limit. The test for constancy of radiation output showed that, the coefficient of variation ranges from 0.005–0.550. In GH3, FMC and AHC, the coefficient of linearity were less than the allowed limit, while in GH1, GH2 and GH4 the coefficient of linearity had exceeded the allowed limit. As regard to mA linearity, FMC and AHC had their coefficients of linearity as 0.12 and 0.10 respectively, which were within the accepted limit, while GH1, GH3 and GH4 had their coefficients as 0.16, 0.69 and 0.98 respectively, which exceeded the allowed limit.

Keywords: radiation, X-ray output, quality control, half-value layer, mA linearity, KVp variation

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Authors: Seulki Lee, Seoung Bum Kim

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Statistical process control (SPC) is a practical and effective method for quality control. The most important and widely used technique in SPC is a control chart. The main goal of a control chart is to detect any assignable changes that affect the quality output. Most conventional control charts, such as Hotelling’s T2 charts, are commonly based on the assumption that the quality characteristics follow a multivariate normal distribution. However, in modern complicated manufacturing systems, appropriate control chart techniques that can efficiently handle the nonnormal processes are required. To overcome the shortcomings of conventional control charts for nonnormal processes, several methods have been proposed to combine statistical learning algorithms and multivariate control charts. Statistical learning-based control charts, such as support vector data description (SVDD)-based charts, k-nearest neighbors-based charts, have proven their improved performance in nonnormal situations compared to that of the T2 chart. Beside the nonnormal property, time-varying operations are also quite common in real manufacturing fields because of various factors such as product and set-point changes, seasonal variations, catalyst degradation, and sensor drifting. However, traditional control charts cannot accommodate future condition changes of the process because they are formulated based on the data information recorded in the early stage of the process. In the present paper, we propose a SVDD algorithm-based control chart, which is capable of adaptively monitoring time-varying and nonnormal processes. We reformulated the SVDD algorithm into a time-adaptive SVDD algorithm by adding a weighting factor that reflects time-varying situations. Moreover, we defined the updating region for the efficient model-updating structure of the control chart. The proposed control chart simultaneously allows efficient model updates and timely detection of out-of-control signals. The effectiveness and applicability of the proposed chart were demonstrated through experiments with the simulated data and the real data from the metal frame process in mobile device manufacturing.

Keywords: multivariate control chart, nonparametric method, support vector data description, time-varying process

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Authors: M. Saba, A. Iaaly, E. Carlier, N. Georges

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This research focuses on assessing the ground water quality of Northern Lebanon affected by saline water intrusion. The chemical, physical and microbiological parameters were collected in various seasons spanning over the period of two years. Results were assessed using Geographic Information System (GIS) due to its visual capabilities in presenting the pollution extent in the studied region. Future projections of the excessive pumping were also simulated using GIS in order to assess the extent of the problem of saline intrusion in the near future.

Keywords: GIS, saline water, quality control, drinkable water quality standards, pumping

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Authors: Merita Dauti, Edita Alili-Idrizi, Sihana Ahmeti –Lika, Ledjan Malaj

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The extermination and proper disposal of pharmaceutical wastes from expired and unused medications remains a disputable issue due to their specific nature and characteristics. Even though the hazards from these wastes are already well known in terms of environment and human health, people still treat them as usual wastes. At a national level, in many countries the management of pharmaceutical and medical wastes has been one of the main objectives in order to protect people’s health and the environment. Even though many legal regulations exist in this respect, there has not been a single law that would clearly explain the procedures of returning medicines, ways of selection, treatment and extermination of pharmaceutical wastes. This paper aims at analyzing the practices of pharmaceutical waste management and treatment in some European countries as well as a review of the legislation and official guidelines in managing these kinds of wastes and protecting the environment and human health. A suitable treatment and management of expired medications and other similar wastes would be in the interest of public health in the first place, as well as in the interest of healthcare institutions and other bodies engaged in environment protection.

Keywords: pharmaceutical waste, legal regulation, proper disposal, environment pollution

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Authors: Saira Tajdar, Sajad Ahmad

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The pharmaceutical market of Pakistan showed a mixed trend since 1947. In these six decades various local and foreign pharmaceutical companies entered the market with their highly researched based formulas and brands for various diseases. It also created a very competitive market between local and foreign companies and brands. But this intense competition does not clear the picture that whether the customers (Doctors) are preferring/prescribing foreign or local brands more frequently. Previous research has been done in various markets for different brands that whether the customers in that industry prefer foreign or local brands. However, the pharmaceutical industry in this regard has been ignored by the researchers. Generally people don't know that for prescription brands of medicines what the preferences of customers (Doctors) are. Therefore, this study is conducted in two departments of Pharmaceutical industry by selecting the top recommended formulas in those departments that for those formulas whether the customers (Doctors) are prescribing either foreign brands or local brands. Secondary data has been collected from previous studies on the country of origin (COO), ethnocentrism and factors influencing brands preferences from authentic sources. Primary data was also collected through 100 self administered questionnaires from top five hospitals of Peshawar. The results of the study were analyzed through SPSS which shows that in some categories of pharmaceutical products the COO is very important but not for all.

Keywords: customer prescription, country of origin, empirical study, foreign versus local brands, pharmaceutical industry, Pakistan

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Authors: S. Sudhharani

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Energy distribution networks are the main link between the energy industry and consumers and are subject to the most scrutiny and testing of any category. As a result, it is important to monitor energy levels during the distribution phase. Power distribution networks, on the other hand, remain subject to common problems, including voltage breakdown, power outages, harmonics, and capacitor switching, all of which disrupt sinusoidal waveforms and reduce the quality and power of the network. Using power appliances in the form of custom power appliances is one way to deal with energy quality issues. Dynamic Voltage Restorer (DVR), integrated with network and distribution networks, is one of these devices. At the same time, by injecting voltage into the system, it can adjust the voltage amplitude and phase in the network. In the form of injections and three-phase syncing, it is used to compensate for the difficulty of energy quality. This article examines the recent use of DVR for power compensation and provides data on the control of each DVR in distribution networks.

Keywords: dynamic voltage restorer (DVR), power quality, distribution networks, control systems(PWM)

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Authors: Seyed Esmail Seyedi Bariran, Khairul Salleh Mohamed Sahari

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Apparent quality defects such as warpage, shrinkage, weld line, etc. are such an irresistible phenomenon in mass production of auto plastic appearance parts. These frequently occurred manufacturing defects should be satisfied concurrently so as to achieve a final product with acceptable quality standards. Determining the significant control factors that simultaneously affect multiple quality characteristics can significantly improve the optimization results by eliminating the deviating effect of the so-called ineffective outliers. Hence, a robust quantitative approach needs to be developed upon which major control factors and their level can be effectively determined to help improve the reliability of the optimal processing parameter design. Hence, the primary objective of current study was to develop a systematic methodology for selection of significant control factors (SCF) relevant to multiple quality optimization of auto plastic appearance part. Auto bumper was used as a specimen with the most identical quality and production characteristics to APAP group. A preliminary failure modes and effect analysis (FMEA) was conducted to nominate a database of pseudo significant significant control factors prior to the optimization phase. Later, CAE simulation Moldflow analysis was implemented to manipulate four rampant plastic injection quality defects concerned with APAP group including warpage deflection, volumetric shrinkage, sink mark and weld line. Furthermore, a step-backward elimination searching method (SESME) has been developed for systematic pre-optimization selection of SCF based on hierarchical orthogonal array design and priority-based one-way analysis of variance (ANOVA). The development of robust parameter design in the second phase was based on DOE module powered by Minitab v.16 statistical software. Based on the F-test (F 0.05, 2, 14) one-way ANOVA results, it was concluded that for warpage deflection, material mixture percentage was the most significant control factor yielding a 58.34% of contribution while for the other three quality defects, melt temperature was the most significant control factor with a 25.32%, 84.25%, and 34.57% contribution for sin mark, shrinkage and weld line strength control. Also, the results on the he least significant control factors meaningfully revealed injection fill time as the least significant factor for both warpage and sink mark with respective 1.69% and 6.12% contribution. On the other hand, for shrinkage and weld line defects, the least significant control factors were holding pressure and mold temperature with a 0.23% and 4.05% overall contribution accordingly.

Keywords: plastic injection moulding, quality optimization, FMEA, ANOVA, SESME, APAP

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Authors: Bruno Pinto Vieira, Marco Antonio Calijorne Soares, Armando Sérgio de Aguiar Filho

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Nowadays, a massive amount of information has been produced by different data sources, including mobile devices and transactional systems. In this scenario, concerns arise on how to maintain or establish data quality, which is now treated as a product to be defined, measured, analyzed, and improved to meet consumers' needs, which is the one who uses these data in decision making and companies strategies. Information that reaches low levels of quality can lead to issues that can consume time and money, such as missed business opportunities, inadequate decisions, and bad risk management actions. The step of selecting, identifying, evaluating, and selecting data sources with significant quality according to the need has become a costly task for users since the sources do not provide information about their quality. Traditional data quality control methods are based on user experience or business rules limiting performance and slowing down the process with less than desirable accuracy. Using advanced machine learning algorithms, it is possible to take advantage of computational resources to overcome challenges and add value to companies and users. In this study, machine learning is applied to data quality analysis on different datasets, seeking to compare the performance of the techniques according to the dimensions of quality assessment. As a result, we could create a ranking of approaches used, besides a system that is able to carry out automatically, data quality assessment.

Keywords: machine learning, data quality, quality dimension, quality assessment

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Authors: Chand Pasha, Yasser Turki Alharbi, Krasamira Stancheva

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A simple spectrophotometric method for the determination of folic acid in pharmaceutical dosage samples was developed. The method is based on the diazotization reaction of thiourea with sodium nitrite in acidic medium yields diazonium compounds, which is then coupled with folic acid in basic medium yields yellow coloured azo dyes. Beer’s Lamberts law is observed in the range 0.5 – 16.2 μgmL-1 at a maximum wavelength of 416nm. The molar absorbtivity, sandells sensitivity, linear regression equation and detection limit and quantitation limit were found to be 5.695×104 L mol-1cm-1, 7.752×10-3 g cm-2, y= 0.092x - 0.018, 0.687 g mL-1 and 2.083 g mL-1. This method successfully determined Folate in Pharmaceutical formulations.

Keywords: folic acid determination, spectrophotometry, diazotization, thiourea, pharmaceutical dosage samples

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Authors: Hamisu Idi

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The present study focuses on studying the impact of influencer recommendation in the quality of cement production. Exploratory research was done on monthly basis, where data were obtained from secondary source i.e. the record kept by an automated recompilation machine. The machine keeps all the records of the mills downtime which the process manager checks for validation and refer the fault (if any) to the department responsible for maintenance or measurement taking so as to prevent future occurrence. The findings indicated that the product of the Ashaka Cement Plc. were considered as qualitative, since all the production processes were found to be in control (preset specifications) with the exception of the natural cause of variation which is normal in the production process as it will not affect the outcome of the product. It is reduced to the bearest minimum since it cannot be totally eliminated. It is also hopeful that the findings of this study would be of great assistance to the management of Ashaka cement factory and the process manager in particular at various levels in the monitoring and implementation of statistical process control. This study is therefore of great contribution to the knowledge in this regard and it is hopeful that it would open more research in that direction.

Keywords: cement, quality, variation, assignable cause, common cause

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Authors: Zheming Cao

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Control loops are the most important components in the wind turbine system. Product quality, operation safety, and the economic performance are directly or indirectly connected to the performance of control systems. This paper proposed a performance evaluation method based on minimum-variance for wind turbine control system. This method can be applied on PID controller for pitch control system in the wind turbine. The good performance result demonstrated in the paper was achieved by retuning and optimizing the controller settings based on the evaluation result. The concepts presented in this paper are illustrated with the actual data of the industrial wind farm.

Keywords: control performance, evaluation, minimum-variance, wind turbine

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Authors: Oktay Nusratov, Ramin Rzaev, Aydin Goyushov

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Fuzzy inference method based approach to the forming of modular intellectual system of assessment the quality of communication services is proposed. Developed under this approach the basic fuzzy estimation model takes into account the recommendations of the International Telecommunication Union in respect of the operation of packet switching networks based on IP-protocol. To implement the main features and functions of the fuzzy control system of quality telecommunication services it is used multilayer feedforward neural network.

Keywords: quality of communication, IP-telephony, fuzzy set, fuzzy implication, neural network

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Authors: Ben Main Piotr Ozieranski

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State government spending on pharmaceuticals stands at 1 trillion USD globally, promoting criticism of the pharmaceutical industry's monetization of drug efficacy, product cost overvaluation, and health injustice. This paper elucidates the mechanisms behind a state-institutional response to this problem through the sociological lens of the strategic relational approach to state power. To do so, 30 expert interviews, legal and policy documents are drawn on to explain how state elites in New Zealand have successfully contested a 30-year “pharmaceutical spending containment policy”. Proceeding from Jessop's notion of strategic “selectivity”, encompassing analyses of the enabling features of state actors' ability to harness state structures, a theoretical explanation is advanced. First, a strategic context is described that consists of dynamics around pharmaceutical dealmaking between the state bureaucracy, pharmaceutical pricing strategies (and their effects), and the industry. Centrally, the pricing strategy of "bundling" -deals for packages of drugs that combine older and newer patented products- reflect how state managers have instigated an “incentivization game” that is played by state and industry actors, including HTA professionals, over pharmaceutical products (both current and in development). Second, a protective context is described that is comprised of successive legislative-judicial responses to the strategic context and characterized by the regulation and the societalisation of commercial law. Third, within the policy, the achievement of increased pharmaceutical coverage (pharmaceutical “mix”) alongside contained spending is conceptualized as a state defence of a "social profit". As such, in contrast to scholarly expectations that political and economic cultures of neo-liberalism drive pharmaceutical policy-making processes, New Zealand's state elites' approach is shown to be antipathetic to neo-liberals within an overall capitalist economy. The paper contributes an analysis of state pricing strategies and how they are embedded in state regulatory structures. Additionally, through an analysis of the interconnections of state power and pharmaceutical value Abrahams's neo-liberal corporate bias model for pharmaceutical policy analysis is problematised.

Keywords: pharmaceutical governance, pharmaceutical bureaucracy, pricing strategies, state power, value theory

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Authors: Gifty Kumadey, Albert Tchey Agbenyegah

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This study explores the role of stakeholders in developing a sustainable supply chain policy framework in Ghana's pharmaceutical industry. It employs a qualitative research design to analyze policy documents, academic articles, and reports, shedding light on stakeholder involvement. The findings highlight the contributions of government agencies, regulatory bodies, pharmaceutical companies, suppliers, and civil society organizations. Key policies such as green procurement, waste management, and recycling initiatives are identified. However, challenges such as limited transparency, supplier engagement, and regulatory complexity impede implementation. The study recommends strengthening collaboration and promoting transparency to overcome these challenges. The findings provide valuable insights for policymakers, industry stakeholders, and researchers seeking to advance sustainable supply chain practices in Ghana's pharmaceutical industry.

Keywords: stakeholders, sustainable supply chain, policy framework, pharmaceutical industry

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Authors: Tina Abrefa-Gyan

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Background: In Ghana and the rest of sub-Saharan Africa, HIV/AIDS is a public health threat and also causes medical crises for many who are infected with the virus. Objective: This study tested a social care intervention developed to help improve the quality of life of those living with HIV/AIDS in Ghana. Method: Adult respondents (N = 248) were assigned to receive the intervention or usual care for six weeks. Results: Results of the study revealed significant differences between the treatment and control groups in their reports of quality of life. Respondents reported better quality of life upon receiving the intervention. Implication: This study sheds light on the positive relationship between the intervention and quality of life among those living with HIV/AIDS in Ghana. Conclusion: The intervention is innovative and novel in the setting. It will, therefore, help to reduce the risks such as depression, low cognitive functioning, and low physical functioning associated with low quality of life among people living with HIV/AIDS in Ghana in specific, and in sub-Saharan Africa in general.

Keywords: social care intervention, HIV/AIDS, Ghana, quality of life

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Authors: S. A. Che Osmi, W. M. F. W. Ishak, S. F. Che Osmi

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Nowadays the issues of water quality and water pollution have been a major problem across the country. A lot of management attempt to develop their own TMDL database in order to control the river pollution. Over the past decade, the mathematical modeling has been used as the tool for the development of TMDL. This paper presents the application of water quality modeling to develop the total maximum daily load (TMDL) information. To obtain the reliable database of TMDL, the appropriate water quality modeling should choose based on the available data provided. This paper will discuss on the use of several water quality modeling such as QUAL2E, QUAL2K, and EFDC to develop TMDL. The attempts to integrate several modeling are also being discussed in this paper. Based on this paper, the differences in the application of water quality modeling based on their properties such as one, two or three dimensional are showing their ability to develop the modeling of TMDL database.

Keywords: TMDL, water quality modeling, QUAL2E, EFDC

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Authors: Rajesh S. Mony, Vaidyaratnam Oushadhasala

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An attempt is made in this study to evolve a drug development modality based on classical Ayurvedic knowledge base as well as on modern scientific methodology. The present study involves (a) identification of a specific ailment condition, (b) the selection of a polyherbal formulation, (c) deciding suitable extraction procedure, (d) confirming the efficacy of the combination by in-vitro trials and (e) fixing up the recommended dose. The ailment segment selected is arthritic condition. The selected herbal combination is Kunturushka, Vibhitaki, Guggulu, Haridra, Maricha and Nirgundi. They were selected as per Classical Ayurvedic references, Authentified as per API (Ayurvedic Pharmacopeia of India), Extraction of each drug was done by different ratios of Hydroalcoholic menstrums, Invitro assessment of each extract after removing residual solvent for anti-Inflammatory, anti-arthritic activities (by UV-Vis. Spectrophotometer with positive control), Invitro assessment of each extract for COX enzyme inhibition (by UV-Vis. Spectrophotometer with positive control), Selection of the extracts was made having good in-vitro activity, Performed the QC testing of each selected extract including HPTLC, that is the in process QC specifications, h. Decision of the single dose with mixtures of selected extracts was made as per the level of in-vitro activity and available toxicology data, Quantification of major groups like Phenolics, Flavonoids, Alkaloids and Bitters was done with both standard Spectrophotometric and Gravimetric methods, Method for Marker assay was developed and validated by HPTLC and a good resolved HPTLC finger print was developed for the single dosage API (Active Pharmaceutical Ingredient mixture of extracts), Three batches was prepared to fix the in process and API (Active Pharmaceutical Ingredient) QC specifications.

Keywords: drug development, antiinflammatory, quality stardardisation, planar chromatography

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Authors: Reginald Anyanwu

Abstract:

Enzymes are biological molecules that significantly regulate the rate of almost all of the chemical reactions that take place within cells, and have been widely used for products’ innovations. They are vital for life and serve a wide range of important functions in the body, such as aiding in digestion and metabolism. The present study was aimed at finding out the extent to which biological molecules have been utilized by pharmaceutical, food and beverage, and biofuel industries in commercial and scale up applications. Taking into account the escalating business opportunities in this vertical, biotech firms have also been penetrating enzymes industry especially that of food. The aim of the study therefore was to find out how biocatalysis can be successfully deployed; how enzyme application can improve industrial processes. To achieve the purpose of the study, the researcher focused on the analytical tools that are critical for the scale up implementation of enzyme immobilization to ascertain the extent of increased product yield at minimum logistical burden and maximum market profitability on the environment and user. The researcher collected data from four pharmaceutical companies located at Anambra state and Imo state of Nigeria. Questionnaire items were distributed to these companies. The researcher equally made a personal observation on the applicability of these biological molecules on innovative Products since there is now shifting trends toward the consumption of healthy and quality food. In conclusion, it was discovered that enzymes have been widely used for products’ innovations but there are however variations on their applications. It was also found out that pivotal contenders of enzymes market have lately been making heavy investments in the development of innovative product solutions. It was recommended that the applications of enzymes on innovative products should be widely practiced.

Keywords: enzymes, pharmaceuticals, process development, quality food consumption, scale-up applications

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Authors: Aghaei Amirkhizi Navideh, Sadjadi Soodeh Sadat, Moghaddam Banaem Leila, Athari Allaf Mitra, Johari Daha Fariba

Abstract:

Dendrimers are good candidates for preparing metal nanoparticles because they can structurally and chemically well-defined templates and robust stabilizers. Poly amidoamine (PAMAM) dendrimer-based multifunctional cancer therapeutic conjugates have been designed and synthesized in pharmaceutical industry. In addition, encapsulated nanoparticle surfaces are accessible to substrates so that catalytic reactions can be carried out. For preparation of dendimer-metal nanocomposite, a dendrimer solution containing an average of 55 Yb+3 ions per dendrimer was prepared. Prior to reduction, the pH of this solution was adjusted to 7.5 using NaOH. NaBH4 was used to reduce the dendrimer-encapsulated Yb+3 to the zerovalent metal. The pH of the resulting solution was then adjusted to 3, using HClO4, to decompose excess BH4-. The UV-Vis absorption spectra of the mixture were recorded to ensure the formation of Yb-G5-NH2 complex. High-resolution electron microscopy (HRTEM) and size distribution results provide additional information about dendimer-metal nanocomposite shape, size, and size distribution of the particles. The resulting mixture was irradiated in Tehran Research Reactor 2h and neutron fluxes were 3×1011 n/cm2.Sec and the specific activity was 7MBq. Radiochemical and chemical and radionuclide quality control testes were carried. Gamma Spectroscopy and High-performance Liquid Chromatography HPLC, Thin-Layer Chromatography TLC were recorded. The injection of resulting solution to solid tumor in mice shows that it could be resized the tumor. The studies about solid tumors and nano composites show that ytterbium encapsulated-dendrimer radiopharmaceutical could be introduced as a new therapeutic for the treatment of solid tumors.

Keywords: nano-radio pharmaceutical, ytterbium, PAMAM, dendrimers

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Authors: Domingo Planes Meseguer, Raffaele Danilo Esposito, Maria Del Pilar Dorado Rodriguez

Abstract:

Monthly quality control checks for a Radiation Therapy Linac may be performed is a simple and efficient way once they have been standardized and protocolized. On the other hand this checks, in spite of being imperatives, require a not negligible execution times in terms of machine time and operators time. Besides it must be taken into account the amount of disposable material which may be needed together with the use of commercial software for their performing. With the aim of optimizing and standardizing mechanical-geometric checks and multi leaves collimator checks, we decided to implement a protocol which makes use of the Electronic Portal Imaging Device (EPID) available on our Linacs. The user is step by step guided by the software during the whole procedure. Acquired images are automatically analyzed by our programs all of them written using only free software.

Keywords: quality control checks, linac, radiation oncology, medical physics, free software

Procedia PDF Downloads 179

Authors: Darren A. Whitaker, Dan Palmer, Jens Wesholowski, James Flaherty, John Mack, Ahmad B. Albadarin, Gavin Walker

Abstract:

Traditional mechanosynthesis has been performed by either ball milling or manual grinding. However, neither of these techniques allow the easy application of process control. The temperature may change unpredictably due to friction in the process. Hence the amount of energy transferred to the reactants is intrinsically non-uniform. Recently, it has been shown that the use of Twin-Screw extrusion (TSE) can overcome these limitations. Additionally, TSE enables a platform for continuous synthesis or manufacturing as it is an open-ended process, with feedstocks at one end and product at the other. Several materials including metal-organic frameworks (MOFs), co-crystals and small organic molecules have been produced mechanochemically using TSE. The described advantages of TSE are offset by drawbacks such as increased process complexity (a large number of process parameters) and variation in feedstock flow impacting on product quality. To handle the above-mentioned drawbacks, this study utilizes UV-Vis spectrophotometry (InSpectroX, ColVisTec) as an online tool to gain real-time information about the quality of the product. Additionally, this is combined with real-time process information in an Advanced Process Control system (PharmaMV, Perceptive Engineering) allowing full supervision and control of the TSE process. Further, by characterizing the dynamic behavior of the TSE, a model predictive controller (MPC) can be employed to ensure the process remains under control when perturbed by external disturbances. Two reactions were studied; a Knoevenagel condensation reaction of barbituric acid and vanillin and, the direct amidation of hydroquinone by ammonium acetate to form N-Acetyl-para-aminophenol (APAP) commonly known as paracetamol. Both reactions could be carried out continuously using TSE, nuclear magnetic resonance (NMR) spectroscopy was used to confirm the percentage conversion of starting materials to product. This information was used to construct partial least squares (PLS) calibration models within the PharmaMV development system, which relates the percent conversion to product to the acquired UV-Vis spectrum. Once this was complete, the model was deployed within the PharmaMV Real-Time System to carry out automated optimization experiments to maximize the percentage conversion based on a set of process parameters in a design of experiments (DoE) style methodology. With the optimum set of process parameters established, a series of PRBS process response tests (i.e. Pseudo-Random Binary Sequences) around the optimum were conducted. The resultant dataset was used to build a statistical model and associated MPC. The controller maximizes product quality whilst ensuring the process remains at the optimum even as disturbances such as raw material variability are introduced into the system. To summarize, a combination of online spectral monitoring and advanced process control was used to develop a robust system for optimization and control of two TSE based mechanosynthetic processes.

Keywords: continuous synthesis, pharmaceutical, spectroscopy, advanced process control

Procedia PDF Downloads 154