Search results for: recalcitrant pharmaceutical

Authors: José M. Carmona, Diana Puigserver, Jofre Herrero

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Chlorinated solvents belong to the group of nonaqueous phase liquids (DNAPL) and have been involved in many contamination episodes. They are carcinogenic and recalcitrant pollutants that may be found in granular aquifers as: i) pools accumulated on low hydraulic conductivity layers; ii) immobile residual phase retained at the pore-scale by capillary forces; iii) dissolved phase in groundwater; iv) sorbed by particulate organic matter; and v) stored into the matrix of low hydraulic conductivity layers where they penetrated by molecular diffusion. The transition zone between granular aquifers and basal aquitards constitute the lowermost part of the aquifer and presents numerous fine-grained interbedded layers that give rise to significant textural contrasts. These layers condition the transport and fate of contaminants and lead to differences from the rest of the aquifer, given that: i) hydraulic conductivity of these layers is lower; ii) DNAPL tends to accumulate on them; iii) groundwater flow is slower in the transition zone and consequently pool dissolution is much slower; iv) sorbed concentrations are higher in the fine-grained layers because of their higher content in organic matter; v) a significant mass of pollutant penetrates into the matrix of these layers; and vi) this contaminant mass back-diffuses after remediation and the aquifer becomes contaminated again. Thus, contamination sources of chlorinated solvents are extremely more recalcitrant in transition zones, which has far-reaching implications for the environment. The aim of this study is to analyze the spatial and temporal differences in the evolution of biogeochemical processes in the transition zone and in the rest of the aquifer. For this, an unconfined aquifer with a transition zone in the lower part was selected at Vilafant (NE Spain). This aquifer was contaminated by perchloroethylene (PCE) in the 80’s. Distribution of PCE and other chloroethenes in groundwater and porewater was analyzed in: a) conventional piezometers along the plume and in two multilevel wells at the source of contamination; and b) porewater of fine grained materials from cores recovered when drilled the two multilevel wells. Currently, the highest concentrations continue to be recorded in the source area in the transition zone. By contrast, the lowest concentrations in this area correspond to the central part of the aquifer, where flow velocities are higher and a greater washing of the residual phase initially retained has occurred. The major findings of the study were: i) PCE metabolites were detected in the transition zone, where conditions were more reducing than in the rest of the aquifer; ii) however, reductive dechlorination was partial since only the formation of cis-dicholoroethylene (DCE) was reached; iii) In the central part of the aquifer, where conditions were predominantly oxidizing, the presence of nitrate significantly hindered the reductive declination of PCE. The remediation strategies to be implemented should be directed to enhance dissolution of the source, especially in the transition zone, where it is more recalcitrant. For example, by combining chemical and bioremediation methods, already tested at the laboratory scale with groundwater and sediments of this site.

Keywords: chlorinated solvents, chloroethenes, DNAPL, partial reductive dechlorination, PCE, transition zone to basal aquitard

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Authors: Bernasconi Matteo, Grothkopp Mark, Friedli Thomas

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The objective of this paper is to examine the relationships between technical and social lean bundles as well as operational performance in the context of the pharmaceutical industry. We investigate the direct and mediating effects of the lean bundles total productive maintenance (TPM), total quality management (TQM), Just-In-Time (JIT), and human resource management (HRM) on operational performance. Our analysis relies on 113 manufacturing facilities from the St.Gallen OPEX benchmarking database. The results show that HRM has a positive indirect effect on operational performance mediated by the technical lean bundles.

Keywords: human resource management, operational performance, pharmaceutical industry, technical lean practices

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Authors: Mohammad Salem Abdullah Alhwaiti

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This study was conducted to assess the physical, chemical, and radionuclide concentrations of pharmaceutical industrial wastewater effluents. Fourteen wastewater samples were collected from pharmaceutical industries. The results showed a marked reduction in the levels of TH, Mg, and Ca concentration in wastewater limit for properties and criteria for discharge of wastewater to streams or wadies or water bodies in the effluent, whereas TSS and TDS showed higher concentration allowable for discharge of wastewater to streams or wadies or water bodies. The gross α activity in all the wastewater samples ranged between (0.086-0.234 Bq/L) lowered the 0.1 Bq/L limit set by World Health Organization (WHO), whereas gross β activity in few samples ranged between (2.565-4.800 Bq/L), indicating the higher limit set by WHO. Gamma spectroscopy revealed that K-40, Cr-51, Co-60, I-131, Cs-137, and U-238 activity are ≤0.114 Bq/L, ≤0.062 Bq/L, ≤0.00815Bq/L, ≤0.00792Bq/L, ≤0.00956 Bq/L, and ≤0.151 Bq/L, respectively, indicating lowest concentrations of these radionuclides in the pharmaceutical industrial wastewater effluents.

Keywords: pharmaceutical wastewater, gross α/β activity, radionuclides, Jordan

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Authors: Johann Valentowitsch, Wolfgang Burr

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In organizational research, strategies of exploration and exploitation are often considered to be contradictory. Building on the tradeoff argument, many authors have assumed that a company's market performance should be positively dependent on its strategic balance between exploration and exploitation over time. In this study, we apply this reasoning to the pharmaceutical industry. Using exploratory regression analysis we show that the long-term market performance of a pharmaceutical company is linked to both its ability to carry out exploratory projects and its ability to develop exploitative competencies. In particular, our findings demonstrate that, on average, the company's annual sales performance is higher the better the strategic alignment between exploration and exploitation is balanced. The contribution of our research is twofold. On the one hand, we provide empirical evidence for the initial tradeoff hypothesis and thus support the theoretical position of those who understand exploration and exploitation as strategic substitutes. On the other hand, our findings show that a balanced relationship between exploration and exploitation is also important in research-intensive industries, which naturally tend to place more emphasis on exploration.

Keywords: exploitation, exploration, market performance, pharmaceutical industry, strategy

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Authors: P. Acosta-Santamaría, A. Ibatá-Soto, A. López-Vásquez

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Organic compounds in wastewaters coming from textile and pharmaceutical industry generated multiple harmful effects on the environment and the human health. One of them is the methyl orange (MeO), an azoic dye considered to be a recalcitrant compound. The heterogeneous photocatalysis emerges as an alternative for treating this type of hazardous compounds, through the generation of OH radicals using radiation and a semiconductor oxide. According to the author’s knowledge, catalysts such as TiO₂ doped with metals show high efficiency in degrading MeO; however, this presents economic limitations on industrial scale. Black sand can be considered as a naturally doped catalyst because in its structure is common to find compounds such as titanium, iron and aluminum oxides, also elements such as zircon, cadmium, manganese, etc. This study reports the photocatalytic activity of the mineral black sand used as semiconductor in the discoloration of MeO by oxidation and reduction photocatalytic techniques. For this, magnetic composites from the mineral were prepared (RM, M1, M2 and NM) and their activity were tested through MeO discoloration while TiO₂ was used as reference. For the fractions, chemical, morphological and structural characterizations were performed using Scanning Electron Microscopy with Energy Dispersive X-Ray (SEM-EDX), X-Ray Diffraction (XRD) and X-Ray Fluorescence (XRF) analysis. M2 fraction showed higher MeO discoloration (93%) in oxidation conditions at pH 2 and it could be due to the presence of ferric oxides. However, the best result to reduction process was using M1 fraction (20%) at pH 2, which contains a higher titanium percentage. In the first process, hydrogen peroxide (H₂O₂) was used as electron donor agent. According to the results, black sand mineral can be used as natural semiconductor in photocatalytic process. It could be considered as a photocatalyst precursor in such processes, due to its low cost and easy access.

Keywords: black sand mineral, methyl orange, oxidation, photocatalysis, reduction

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Authors: Kanika Saxena, Sunita Balani

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Purpose - The aim of the study is to compare the reported sustainability activities in areas of emission, water management and gender equality, currently undertaken by the seven major pharmaceutical companies. Methodology: The published corporate sustainability activity reports for the year 2017 for seven pharmaceutical companies have been studied. The two main criteria for the inclusion of pharmaceutical companies in this study are that they are globally recognized and active in the field of sustainability reporting. Company’s actions and initiatives have been grouped under three categories: (i) Emissions (ii) Water management (iii) Gender Equality in terms of employee workforce. Findings: Based on the sustainability reports, quantification and grading of the companies showed interesting results. Johnson & Johnson and Bayer are leading their activities under emissions and water management categories. The number of activities under emission and water management in case of Eli Lily, Roche, Sanofi, Pfizer and GlaxoSmithKline were 19, 16, 16, 11 and 6 respectively. Johnson & Johnson and Eli Lily are leading in taking the initiatives to curb the problem of emissions as compared with other 5 companies. Under the category of gender equality in terms of employee workforce, Eli Lily is leading the group of sampled companies with 47% of women employee workforce globally followed by Sanofi with 46.2% (42.2% of managers) female employees. It has also been observed that in some of the reports, gender diversification in the workforce has not been mentioned though the total number of employees were mentioned. Conclusion: This study could serve as the informative material for future in-depth industry-specific studies in order to find out the participation of the pharmaceutical companies in the reporting of the sustainability activities especially in reference to emission, water management and gender equality in the workforce. In addition to it, this can be helpful as a reference point for other companies in the pharmaceutical sector who are yet to explore the field of sustainability initiatives and reporting. Due to the limited scope of this study, only seven major players of the pharmaceutical sector who are active in the field of sustainability have been considered.

Keywords: emission, gender equality workforce, pharmaceutical, sustainability, water management

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Authors: Amit Das

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Background and significance of the study: Generally investors and market forecasters use financial statement for investigation while it awakens contribute to investing. The main vicinity of financial accounting and reporting practices recommends a few basic financial performance indicators, namely, return on capital employed, return on assets and earnings per share, which is associated considerably with share prices. It is principally true in case of Indian pharmaceutical companies also. Share investing is intriguing a financial risk in addition to investors look for those financial evaluations which have noteworthy shock on share price. A crucial intention of financial statement analysis and reporting is to offer information which is helpful predominantly to exterior clients in creating credit as well as investment choices. Sound financial performance attracts the investors automatically and it will increase the share price of the respective companies. Keeping in view of this, this research work investigates the impact of financial performance indicators on share price of pharmaceutical companies in India which is listed in the Bombay Stock Exchange. Methodology: This research work is based on secondary data collected from moneycontrol database on September 28, 2015 of top 101 pharmaceutical companies in India. Since this study selects four financial performance indicators purposively and availability in the database, that is, earnings per share, return on capital employed, return on assets and net profits as independent variables and one dependent variable, share price of 101 pharmaceutical companies. While analysing the data, correlation statistics, multiple regression technique and appropriate test of significance have been used. Major findings: Correlation statistics show that four financial performance indicators of 101 pharmaceutical companies are associated positively and negatively with its share price and it is very much significant that more than 80 companies’ financial performances are related positively. Multiple correlation test results indicate that financial performance indicators are highly related with share prices of the selected pharmaceutical companies. Furthermore, multiple regression test results illustrate that when financial performances are good, share prices have been increased steadily in the Bombay stock exchange and all results are statistically significant. It is more important to note that sensitivity indices were changed slightly through financial performance indicators of selected pharmaceutical companies in India. Concluding statements: The share prices of pharmaceutical companies depend on the sound financial performances. It is very clear that share prices are changed with the movement of two important financial performance indicators, that is, earnings per share and return on assets. Since 101 pharmaceutical companies are listed in the Bombay stock exchange and Sensex are changed with this, it is obvious that Government of India has to take important decisions regarding production and exports of pharmaceutical products so that financial performance of all the pharmaceutical companies are improved and its share price are increased positively.

Keywords: financial performance indicators, share prices, pharmaceutical companies, India

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Authors: Diana Puigserver Cuerda, Jofre Herrero Ferran, José M. Carmona Perez

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In the transition zone between aquifers and basal aquitards, DNAPL-pools of chlorinated solvents are more recalcitrant than at other depths in the aquifer. Although degradation of carbon tetrachloride (CT) and chloroform (CF) occurs in this zone, this is a slow process, which is why an adequate remediation strategy is necessary. The working hypothesis of this study is that the biostimulation of the transition zone of an aquifer contaminated by CT and CF can be an effective remediation strategy. This hypothesis has been tested in a site on an unconfined aquifer in which the major contaminants were CT and CF of industrial origin and where the hydrochemical background was rich in other compounds that can hinder natural attenuation of chloromethanes. Field studies and five laboratory microcosm experiments were carried out at the level of groundwater and sediments to identify: i) the degradation processes of CT and CF; ii) the structure of microbial communities; and iii) the microorganisms implicated on this degradation. For this, concentration of contaminants and co-contaminants (nitrate and sulfate), Compound Specific Isotope Analysis, molecular techniques (Denaturing Gradient Gel Electrophoresis) and clone library analysis were used. The main results were: i) degradation processes of CT and CF occurred in groundwater and in the lesser conductive sediments; ii) sulfate-reducing conditions in the transition zone were high and similar to those in the source of contamination; iii) two microorganisms (Azospira suillum and a bacterium of the Clostridiales order) were identified in the transition zone at the field and lab experiments that were compatible with the role of carrying out the reductive dechlorination of CT, CF and their degradation products (dichloromethane and chloromethane); iv) these two microorganisms were present at the high starting concentrations of the microcosm experiments (similar to those in the source of DNAPL) and continued being present until the last day of the lactate biostimulation; and v) the lactate biostimulation gave rise to the fastest and highest degradation rates and promoted the elimination of other electron acceptors (e.g. nitrate and sulfate). All these results are evidence that lactate biostimulation can be effective in remediating the source and plume, especially in the transition zone, and highlight the environmental relevance of the treatment of contaminated transition zones in industrial contexts similar to that studied.

Keywords: Azospira suillum, lactate biostimulation of carbon tetrachloride and chloroform, reductive dechlorination, transition zone between aquifer and aquitard

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Authors: Shilpi Tyagi, D. K. Nauriyal

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This study investigates the firm level determinants of profitability of Indian drug and pharmaceutical industry. The study uses inflation adjusted panel data for a period 2000-2013 and applies OLS regression model with Driscoll-Kraay standard errors. It has been found that export intensity, A&M intensity, firm’s market power and stronger patent regime dummy have exercised positive influence on profitability. The negative and statistically significant influence of R&D intensity and raw material import intensity points to the need for firms to adopt suitable investment strategies. The study suggests that firms are required to pay far more attention to optimize their operating expenditures, advertisement and marketing expenditures and improve their export orientation, as part of the long term strategy.

Keywords: Indian pharmaceutical industry, profits, TRIPS, performance

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Authors: Wafa Jahouach-Rabai, Khouloud Ouerghi, Zohra Azzouz-Berriche, Faouzi Hosni

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Widely used organic products in the pharmaceutical industry have been detected in environmental systems, essentially carboxylic acids. In this purpose, the degradation efficiency of these contaminants was evaluated using an advanced oxidation process (AOP), namely ionization process as an alternative to conventional water treatment technologies. This process permitted the generation of radical reactions to directly degrade organic pollutants in wastewater. In fact, gamma irradiation of aqueous solutions produces several reactive radicals, essentially hydroxyl radical (OH), to destroy recalcitrant pollutants. Different concentrations of aqueous solutions of Fumaric acid (FA) were considered in this study (0.1-1 mmol/L), which were treated by irradiation doses from 1 to 15 kGy with 6.1 kGy/h rate by ionizing system in pilot scale (⁶⁰Co irradiator). Variations of main parameters influencing degradation efficiency versus absorbed doses were released in the aim to optimize total mineralization of considered pollutants. Preliminary degradation pathway until complete mineralization into CO₂ has been suggested based on detection of residual degradation derivatives using different techniques, namely high performance liquid chromatography (HPLC) and electron paramagnetic resonance spectroscopy (EPR). Results revealed total destruction of treated compound, which improve the efficiency of this process in water remediation. We investigated the reactivity of hydroxyl radicals generated by irradiation on dicarboxylic acid (FA) in aqueous solutions, leading to its degradation into other smaller molecules. In fact, gamma irradiation of FA leads to the formation of hydroxylated intermediates such as hydroxycarbonyl radical which were identified by EPR spectroscopy. Finally, pilot plant irradiation facilities improved the applicability of radiation technology on large scale.

Keywords: AOP, radiolysis, fumaric acid, gamma irradiation, hydroxyl radical, EPR, HPLC

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Authors: Muhammad Danyal Khan

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The standards of patentability are drawing a great impact upon medicine industry of Pakistan which is indirectly troubling the right to health of ordinary citizen. Globalization of intellectual property laws is directly impacting access to medicine for population in Pakistan. Pakistan has enacted Patent Ordinance 2000 to develop the standards of Patent laws in consonance with international commitments. Moreover, Pakistan is signatory to UN Millennium Development Goals (2000-2015), and three of them directly put stress upon the health standards. This article will provide a critical brief about implications of TRIPS Agreement on standards of health in Pakistan and will also propose a futuristic approach for the pharmaceutical industry. This paper will define the paradox of globalization and national preparedness on pharmaceutical patents utilizing industry statistics and case laws from Pakistan. Moreover, this work will contribute towards debate on access to medicine at legislative and interpretative levels that will further help development of equilibrium between pharmaceutical patents and right to health.

Keywords: TRIPS (Trade Related Intellectual Property Rights), patents, compulsory licensing, patent, lifesaving drugs, WTO, infringement

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Authors: Stephan Koehler, Thomas Friedli

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Performance measurement has evolved over time from a unidimensional short-term efficiency focused approach into a balanced multidimensional approach. Today, integrated performance measurement frameworks are often used to avoid local optimization and to encourage continuous improvement of an organization. In literature, the multidimensional characteristic of performance measurement is often described by competitive priorities. At the same time, on the highest abstraction level an effectiveness and efficiency dimension of performance measurement can be distinguished. This paper aims at a better understanding of the composition of effectiveness and efficiency and their relation in pharmaceutical quality control labs. The research comprises a lab-specific operationalization of effectiveness and efficiency and examines how the two dimensions are interlinked. The basis for the analysis represents a database of the University of St. Gallen including a divers set of 40 different pharmaceutical quality control labs. The research provides empirical evidence that labs with a high effectiveness also accompany a high efficiency. Lab effectiveness explains 29.5 % of the variance in lab efficiency. In addition, labs with an above median operational excellence performance have a statistically significantly higher lab effectiveness and lab efficiency compared to the below median performing labs.

Keywords: empirical study, operational excellence, performance measurement, pharmaceutical quality control lab

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Authors: Ilham Benali, Nasser Hajji, Nawfal Acha

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Given the fact that the pharmaceutical industry is a commonly studied sector in the context of innovation, the majority of innovation research is devoted to the developed markets known by high research and development (R&D) assets and intensive innovation. In contrast, in developing countries where R&D assets are very low, there is relatively little research to mention in the area of pharmaceutical sector innovation, characterized mainly by two principal elements which are the presence of foreign-owned firms and licensed manufacturing agreements between local firms and multinationals. With the scarcity of research in this field, this paper attempts to study the effect of these two elements on the firms’ innovation tendencies. Other traditional factors that influence innovation, which are the age and the size of the firm, the R&D activities and the market structure, revealed in the literature review, will be included in the study in order to try to make this work more exhaustive. The study starts by examining innovation tendency in pharmaceutical firms located in developing countries before analyzing the effect of foreign-owned firms and licensed manufacturing agreements between local firms and multinationals on technological, organizational and marketing innovation. Based on the related work and on the theoretical framework developed, there is a probability that foreign-owned firms and licensed manufacturing agreements between local firms and multinationals have a negative influence on technological innovation. The opposite effect is possible in the case of organizational and marketing innovation.

Keywords: developing countries, foreign owned firms, innovation, licensed manufacturing agreements, pharmaceutical industry

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Authors: Jing (Claire) LI

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The topic of corporate social responsibility (CSR) is significant for pharmaceutical companies in China at this current stage. This is because, as a rapid growth industry in China in recent years, the pharmaceutical industry in China has been undergone continuous and terrible incidents relating to CSR. However, there is limited research and practice of CSR in Chinese pharmaceutical companies. Also, there is an urgent call for more research in an international context to understand the implications of corporate life cycle on CSR performance. To respond to the research need and research call, this study examines the relationship between corporate life cycle and CSR performance of Chinese listed companies in pharmaceutical industry. This research studies Chinese listed companies in pharmaceutical industry for the period of 2010-2017, where the data is available in database. Following the literature, this study divides CSR performance with regards to CSR dimensions, including shareholders, creditors, employees, customers, suppliers, the government, and the society. This study uses CSR scores of HEXUN database and financial measures of these CSR dimensions to measure the CSR performance. This study performed regression analysis to examine the relationship between corporate life cycle stages and CSR performance with regards to CSR dimensions for pharmaceutical listed companies in China. Using cash flow pattern as proxy of corporate life cycle to classify corporate life cycle stages, this study found that most (least) pharmaceutical companies in China are in maturity (decline) stage. This study found that CSR performance for most dimensions are highest (lowest) in maturity (decline) stage as well. Among these CSR dimensions, performing responsibilities for shareholder is the most important among all CSR responsibilities for pharmaceutical companies. This study is the first to provide important empirical evidence from Chinese pharmaceutical industry on the association between life cycle and CSR performance, supporting that corporate life cycle is a key factor in CSR performance. The study expands corporate life cycle and CSR literatures and has both empirical and theoretical contributions to the literature. From perspective of empirical contributions, the findings contribute to the argument that whether there is a relationship between CSR performance and various corporate life cycle stages in the literature. This study also provides empirical evidence that companies in different corporate life cycles have difference in CSR performance. From perspective of theoretical contributions, this study relates CSR and stakeholders to corporate life cycle stages and complements the corporate life cycle and CSR literature. This study has important implications for managers and policy makers. First, the results will be helpful for managers to have an understanding in the essence of CSR, and their company’s current and future CSR focus over corporate life cycle. This study provides a reference for their actions and may help them make more wise resources allocation decisions of CSR investment. Second, policy makers (in the government, stock exchanges, and securities commission) may consider corporate life cycle as an important factor in formulating future regulations for companies. Future research can explore the "process-based" differences in CSR performance and more industries.

Keywords: China, corporate life cycle, corporate social responsibility, pharmaceutical industry

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Authors: Farzad Khajavi

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Recognition of the interaction between active pharmaceutical ingredients (API) and excipients is a pivotal factor in the development of all pharmaceutical dosage forms. By predicting the interaction between API and excipients, we will be able to prevent the advent of impurities or at least lessen their amount. In this study, we used principle component analysis (PCA) to predict the interaction between Gliclazide as a secondary amine with Lactose in pharmaceutical solid dosage forms. The infrared spectra of binary mixtures of Gliclazide with Lactose at different mole ratios were recorded, and the obtained matrix was analyzed with PCA. By plotting score columns of the analyzed matrix, the incompatibility between Gliclazide and Lactose was observed. This incompatibility was seen experimentally. We observed the appearance of the impurity originated from the Maillard reaction between Gliclazide and Lactose at the chromatogram of the manufactured tablets in room temperature and under accelerated stability conditions. This impurity increases at the stability months. By changing Lactose to Mannitol and using Calcium Dibasic Phosphate in the tablet formulation, the amount of the impurity decreased and was in the acceptance range defined by British pharmacopeia for Gliclazide Tablets. This method is a fast and simple way to predict the existence of incompatibility between excipients and active pharmaceutical ingredients.

Keywords: PCA, gliclazide, impurity, infrared spectroscopy, interaction

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Authors: J. Satya Eswari, Ch. Venkateswarlu

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The formulation of a commercial pharmaceutical product involves several composition factors and response characteristics. When the formulation requires to satisfy multiple response characteristics which are conflicting, an optimal solution requires the need for an efficient multiobjective optimization technique. In this work, a regression is combined with a non-dominated sorting differential evolution (NSDE) involving Naïve & Slow and ε constraint techniques to derive different multiobjective optimization strategies, which are then evaluated by means of a trapidil pharmaceutical formulation. The analysis of the results show the effectiveness of the strategy that combines the regression model and NSDE with the integration of both Naïve & Slow and ε constraint techniques for Pareto optimization of trapidil formulation. With this strategy, the optimal formulation at pH=6.8 is obtained with the decision variables of micro crystalline cellulose, hydroxypropyl methylcellulose and compression pressure. The corresponding response characteristics of rate constant and release order are also noted down. The comparison of these results with the experimental data and with those of other multiple regression model based multiobjective evolutionary optimization strategies signify the better performance for optimal trapidil formulation.

Keywords: pharmaceutical formulation, multiple regression model, response surface method, radial basis function network, differential evolution, multiobjective optimization

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Authors: Gule Teri

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The effective validation of analytical methods forms a crucial component of pharmaceutical manufacturing. However, traditional validation techniques can occasionally fail to fully account for inherent variations within datasets, which may result in inconsistent outcomes. This deficiency in validation accuracy is particularly noticeable when quantifying low concentrations of active pharmaceutical ingredients (APIs), excipients, or impurities, introducing a risk to the reliability of the results and, subsequently, the safety and effectiveness of the pharmaceutical products. In response to this challenge, we introduce an enhanced, tolerance-based Design of Experiments (DoE) approach for the validation of analytical methods. This approach distinctly measures variability with reference to tolerance or design margins, enhancing the precision and trustworthiness of the results. This method provides a systematic, statistically grounded validation technique that improves the truthfulness of results. It offers an essential tool for industry professionals aiming to guarantee the accuracy of their measurements, particularly for low-concentration components. By incorporating this innovative method, pharmaceutical manufacturers can substantially advance their validation processes, subsequently improving the overall quality and safety of their products. This paper delves deeper into the development, application, and advantages of this tolerance-based DoE approach and demonstrates its effectiveness using High-Performance Liquid Chromatography (HPLC) data for verification. This paper also discusses the potential implications and future applications of this method in enhancing pharmaceutical manufacturing practices and outcomes.

Keywords: tolerance-based design, design of experiments, analytical method validation, quality control, biopharmaceutical manufacturing

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Authors: Snezana Savoska, Blagoj Ristevski, Violeta Manevska, Zlatko Savoski, Ilija Jolevski

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Big data is widely accepted by the pharmaceutical companies as a result of business demands create through legal pressure. Pharmaceutical companies have many legal demands as well as standards’ demands and have to adapt their procedures to the legislation. To manage with these demands, they have to standardize the usage of the current information technology and use the latest software tools. This paper highlights some important aspects of experience with big data projects implementation in a pharmaceutical Macedonian company. These projects made improvements of their business processes by the help of new software tools selected to comply with legal and business demands. They use IT as a strategic tool to obtain competitive advantage on the market and to reengineer the processes towards new Internet economy and quality demands. The company is required to manage vast amounts of structured as well as unstructured data. For these reasons, they implement projects for emerging and appropriate software tools which have to deal with big data concepts accepted in the company.

Keywords: big data, unstructured data, SAP ERP, documentum

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Authors: Rajeev Ravindran, Amit K. Jaiswal

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Lignocellulose is the largest reservoir of inexpensive, renewable source of carbon. It is composed of lignin, cellulose and hemicellulose. Cellulose and hemicellulose is composed of reducing sugars glucose, xylose and several other monosaccharides which can be metabolised by microorganisms to produce several value added products such as biofuels, enzymes, aminoacids etc. Enzymatic treatment of lignocellulose leads to the release of monosaccharides such as glucose and xylose. However, factors such as the presence of lignin, crystalline cellulose, acetyl groups, pectin etc. contributes to recalcitrance restricting the effective enzymatic hydrolysis of cellulose and hemicellulose. In order to overcome these problems, pre-treatment of lignocellulose is generally carried out which essentially facilitate better degradation of lignocellulose. A range of pre-treatment strategy is commonly employed based on its mode of action viz. physical, chemical, biological and physico-chemical. However, existing pretreatment strategies result in lower sugar yield and formation of inhibitory compounds. In order to overcome these problems, we proposes a novel pre-treatment, which utilises the superior oxidising capacity of alkaline potassium permanganate assisted by ultra-sonication to break the covalent bonds in spent coffee waste to remove recalcitrant compounds such as lignin. The pre-treatment was conducted for 30 minutes using 2% (w/v) potassium permanganate at room temperature with solid to liquid ratio of 1:10. The pre-treated spent coffee waste (SCW) was subjected to enzymatic hydrolysis using enzymes cellulase and hemicellulase. Shake flask experiments were conducted with a working volume of 50mL buffer containing 1% substrate. The results showed that the novel pre-treatment strategy yielded 7 g/L of reducing sugar as compared to 3.71 g/L obtained from biomass that had undergone dilute acid hydrolysis after 24 hours. From the results obtained it is fairly certain that ultrasonication assists the oxidation of recalcitrant components in lignocellulose by potassium permanganate. Enzyme hydrolysis studies suggest that ultrasound assisted alkaline potassium permanganate pre-treatment is far superior over treatment by dilute acid. Furthermore, SEM, XRD and FTIR were carried out to analyse the effect of the new pre-treatment strategy on structure and crystallinity of pre-treated spent coffee wastes. This novel one-step pre-treatment strategy was implemented under mild conditions and exhibited high efficiency in the enzymatic hydrolysis of spent coffee waste. Further study and scale up is in progress in order to realise future industrial applications.

Keywords: spent coffee waste, alkaline potassium permanganate, ultra-sonication, physical characterisation

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Authors: Faisal Ali, Mansoor Shuakat, Cui Lirong, Rabia Riasat

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HR is a department that enhances the power of employee performance in regard with their services, and to make the organization strategic objectives. The main concern of HR department is to organize people, focus on policies and their system. The empirical study shows the relationship between HRM (Human Resource Management practices) and their Job Satisfaction. The Hypothesis is testing on a sample of overall 320 employees of 5 different Pharmaceutical departments of different organizations in Pakistan. The important thing as Relationship of Job satisfaction with HR Practices, Impact on Job Satisfaction with HR Practices, Participation of Staff of Different Departments, HR Practices effects the Job satisfaction, Recruitment or Hiring and Selection effects the Job satisfaction, Training and Development, Performance and Appraisals, Compensation affects the Job satisfaction , and Industrial Relationships affects the Job satisfaction. After finishing all data analysis, the conclusion is that lots of Job related activities raise the confidence of Job satisfaction of employees with their salary and other benefits. Implications of HR practices discussed, Limitations, and future research study also offered write the main conclusion for your paper.

Keywords: HRM, HR practices, job satisfaction, TQM

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Authors: Gifty Kumadey, Albert Tchey Agbenyegah

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(i) Overview and research goal(s): This study aims to address research gaps in the Ghanaian pharmaceutical industry by examining the impact of environmental supply chain management (ESCM) practices on environmental and operational performance. Previous studies have provided inconclusive evidence on the relationship between ESCM practices and environmental and operational performance. The research aims to provide a clearer understanding of the impact of ESCM practices on environmental and operational performance in the context of the Ghanaian pharmaceutical industry. Limited research has been conducted on ESCM practices in developing countries, particularly in Africa. The study aims to bridge this gap by examining the drivers and barriers specific to the pharmaceutical industry in Ghana. The research aims to analyze the impact of ESCM practices on the achievement of Sustainable Development Goals (SDGs) in the Ghanaian pharmaceutical industry, focusing on SDGs 3, 12, 13, and 17. It also explores the potential for partnerships and collaborations to advance ESCM practices in the pharmaceutical industry. The research hypotheses suggest that pressure from stakeholder positively influences the adoption of ESCM practices in the Ghanaian pharmaceutical industry. By addressing these goals, the study aims to contribute to sustainable development initiatives and offer practical recommendations to enhance ESCM A practices in the industry. (ii) Research methods and data: This study uses a quantitative research design to examine the drivers and barriers to environmental supply chain management in the pharmaceutical industry in Accra.The sample size is approximately 150 employees, with senior and middle-level managers from pharmaceutical industry of Ghana. A purposive sampling technique is used to select participants with relevant knowledge and experience in environmental supply chain management. Data will be collected using a structured questionnaire using Likert scale responses. Descriptive statistics will be used to analyze the data and provide insights into current practices and their impact on environmental and operational performance. (iii) Preliminary results and conclusions: Main contributions: Identifying drivers/barriers to ESCM in Ghana's pharmaceutical industry, evaluating current ESCM practices, examining impact on performance, providing practical insights, contributing to knowledge on ESCM in Ghanaian context. The research contributes to SDGs 3, 9, and 12 by promoting sustainable practices and responsible consumption in the industry. The study found that government rules and regulations are the most critical drivers for ESCM adoption, with senior managers playing a significant role. However, employee and competitor pressures have a lesser impact. The industry has made progress in implementing certain ESCM practices, but there is room for improvement in areas like green distribution and reverse logistics. The study emphasizes the importance of government support, management engagement, and comprehensive implementation of ESCM practices in the industry. Future research should focus on overcoming barriers and challenges to effective ESCM implementation.

Keywords: environmental supply chain, sustainable development goal, ghana pharmaceutical industry, government regulations

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Authors: Septiany Trisnaningtyas

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Purpose: This research aims to examine the factors affecting the profitability of pharmaceutical company during the Covid-19 Pandemic in Indonesia. A sharp decline in the number of patients coming to the hospital for treatment during the pandemic has an impact on the growth of the pharmaceutical sector and brought major changes in financial position and business performance. Pharmaceutical companies that provide products related to the Covid-19 pandemic can survive and continue to grow. This study investigates the factors affecting the profitability of pharmaceutical company during the Covid-19 Pandemic in Indonesia associated with the number of Covid-19 cases. Design/methodology/approach: This study uses panel-data regression models to evaluate the influence of the number of Covid-19 confirmed cases on profitability of ninelisted pharmaceuticalcompanies in Indonesia. This research is based on four independent variables that were empirically examined for their relationship with profitability. These variables are liquidity (current ratio), growth rate (sales growth), firm size (total sales), and market power (the Lerner index). Covid-19 case is used as moderating variable. Data of nine pharmaceutical companies listed on the Indonesia Stock Exchange covering the period of 2018–2021 were extracted from companies’ quarterly annual reports. Findings: In the period during Covid-19, company growth (sales growth) and market power (lerner index) have a positive and significant relationship to ROA and ROE. Total of confirmed Covid-19 cases has a positive and significant relationship to ROA and is proven to have a moderating effect between company’s growth (sales growth) to ROA and ROE and market power (Lerner index) to ROA. Research limitations/implications: Due to data availability, this study only includes data from nine listed pharmaceutical companies in Indonesian Stock exchange and quarterly annual reportscovering the period of 2018-2021. Originality/value: This study focuses onpharmaceutical companies in Indonesia during Covid-19 pandemic. Previous study analyzes the data from pharmaceutical companies’ annual reports since 2014 and focus on universal health coverage (national health insurance) implementation from the Indonesian government. This study analyzes the data using fixed effect panel-data regression models to evaluate the influence of Covid-19 confirmed cases on profitability. Pooled ordinary least squares regression and fixed effects were used to analyze the data in previous study. This study also investigate the moderating effect of Covid-19 confirmed cases to profitability in relevant with the pandemic situation.

Keywords: profitability, indonesia, pharmaceutical, Covid-19

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Authors: Maryam Ziaee, Himanshu Shee, Amrik Sohal

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Big Data Analytics (BDA) in supply chain management has recently drawn the attention of academics and practitioners. Big data refers to a massive amount of data from different sources, in different formats, generated at high speed through transactions in business environments and supply chain networks. Traditional statistical tools and techniques find it difficult to analyse this massive data. BDA can assist organisations to capture, store, and analyse data specifically in the field of supply chain. Currently, there is a paucity of research on BDA in the pharmaceutical supply chain context. In this research, the Australian pharmaceutical supply chain was selected as the case study. This industry is highly significant since the right medicine must reach the right patients, at the right time, in right quantity, in good condition, and at the right price to save lives. However, drug shortages remain a substantial problem for hospitals across Australia with implications on patient care, staff resourcing, and expenditure. Furthermore, a massive volume and variety of data is generated at fast speed from multiple sources in pharmaceutical supply chain, which needs to be captured and analysed to benefit operational decisions at every stage of supply chain processes. As the pharmaceutical industry lags behind other industries in using BDA, it raises the question of whether the use of BDA can improve transparency among pharmaceutical supply chain by enabling the partners to make informed-decisions across their operational activities. This presentation explores the impacts of BDA on supply chain management. An exploratory qualitative approach was adopted to analyse data collected through interviews. This study also explores the BDA potential in the whole pharmaceutical supply chain rather than focusing on a single entity. Twenty semi-structured interviews were undertaken with top managers in fifteen organisations (five pharmaceutical manufacturers, five wholesalers/distributors, and five public hospital pharmacies) to investigate their views on the use of BDA. The findings revealed that BDA can enable pharmaceutical entities to have improved visibility over the whole supply chain and also the market; it enables entities, especially manufacturers, to monitor consumption and the demand rate in real-time and make accurate demand forecasts which reduce drug shortages. Timely and precise decision-making can allow the entities to source and manage their stocks more effectively. This can likely address the drug demand at hospitals and respond to unanticipated issues such as drug shortages. Earlier studies explore BDA in the context of clinical healthcare; however, this presentation investigates the benefits of BDA in the Australian pharmaceutical supply chain. Furthermore, this research enhances managers’ insight into the potentials of BDA at every stage of supply chain processes and helps to improve decision-making in their supply chain operations. The findings will turn the rhetoric of data-driven decision into a reality where the managers may opt for analytics for improved decision-making in the supply chain processes.

Keywords: big data analytics, data-driven decision, pharmaceutical industry, supply chain management

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Authors: Zelikha Labbani

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Durum wheat represents an attractive species to study androgenesis via isolated microspore culture in order to increase the efficiency of androgenic yield in recalcitrant species such as in induction embryogenesis. We describe here an efficient method for inducing embryos from isolated microspores of durum wheat. It is shown that this method, associated with cold alone or cold plus mannitol pretreatment, or mannitol alone of the spikes kept within their sheath leaves during different times, has significant positive effects on embryo production. The aim of this study was, therefore, to test the effect of mannitol 0,3M and cold pretreatment on the quality and quantity of embryos produced from microspore culture from wheat cultivars.

Keywords: in vitro embryogenesis, isolated microspores culture, durum wheat, pretreatments, mannitol 0.3m, cold pretreatment

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Authors: Lourenco Camnahas, Eileen Willis, Greg Fisher, Jessie Gunson, Pascale Dettwiller, Charlene Thornton

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Stock-out of pharmaceuticals is a common issue at all level of health services in Timor-Leste, a small post-conflict country. This lead to the research questions: what are the current methods used to quantify pharmaceutical supplies; what factors contribute to the on-going pharmaceutical stock-out? The study examined factors that influence the pharmaceutical supply chain system. Methodology: Privett and Goncalvez dependency model has been adopted for the design of the qualitative interviews. The model examines pharmaceutical supply chain management at three management levels: management of individual pharmaceutical items, health facilities, and health systems. The interviews were conducted in order to collect information on inventory management, logistics management information system (LMIS) and the provision of pharmaceuticals. Andersen' behavioural model for healthcare utilization also informed the interview schedule, specifically factors linked to environment (healthcare system and external environment) and the population (enabling factors). Forty health professionals (bureaucrats, clinicians) and six senior officers from a United Nations Agency, a global multilateral agency and a local non-governmental organization were interviewed on their perceptions of factors (healthcare system/supply chain and wider environment) impacting on stock out. Additionally, policy documents for the entire healthcare system, along with population data were collected. Findings: An analysis using Pozzebon’s critical interpretation identified a range of difficulties within the system from poor coordination to failure to adhere to policy guidelines along with major difficulties with inventory management, quantification, forecasting, and budgetary constraints. Weak logistics management information system, lack of capacity in inventory management, monitoring and supervision are additional organizational factors that also contributed to the issue. There were various methods of quantification of pharmaceuticals applied in the government sector, and non-governmental organizations. Lack of reliable data is one of the major problems in the pharmaceutical provision. Global Fund has the best quantification methods fed by consumption data and malaria cases. There are other issues that worsen stock-out: political intervention, work ethic and basic infrastructure such as unreliable internet connectivity. Major issues impacting on pharmaceutical quantification have been identified. However, current data collection identified limitations within the Andersen model; specifically, a failure to take account of predictors in the healthcare system and the environment (culture/politics/social. The next step is to (a) compare models used by three non-governmental agencies with the government model; (b) to run the Andersen explanatory model for pharmaceutical expenditure for 2 to 5 drug items used by these three development partners in order to see how it correlates with the present model in terms of quantification and forecasting the needs; (c) to repeat objectives (a) and (b) using the government model; (d) to draw a conclusion about the strength.

Keywords: inventory management, pharmaceutical forecasting and quantification, pharmaceutical stock-out, pharmaceutical supply chain management

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Authors: Abu Zafor Sadek

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Pharmaceuticals were one of the least impacted business sectors during the corona pandemic as they are the center point of Covid-19 fight. Emergency use authorization, unproven indication of some commonly used drugs, self-medication, research and production capacity of an individual country, capacity of producing vaccine by many countries, Active Pharmaceutical Ingredients (APIs) related uncertainty, information gap among manufacturer, practitioners and user, export restriction, duration of lock-down, lack of harmony in transportation, disruption in the regulatory approval process, sudden increased demand of hospital items and protective equipment, panic buying, difficulties in in-person product promotion, e-prescription, geo-politics and associated issues added a new dimension to this industry. Although the industry maintains a reasonable growth throughout Covid-19 days; however, it has been characterized by both long- and short-term effects. Short-term effects have already been visible to so many countries, especially those who are import-dependent and have limited research capacity. On the other hand, it will take a few more time to see the long-term effects. Nevertheless, supply chain disruption, changes in strategic planning, new communication model, squeezing of job opportunity, rapid digitalization are the major short-term effects, whereas long-term effects include a shift towards self-sufficiency, growth pattern changes of certain products, special attention towards clinical studies, automation in operations, the increased arena of ethical issues etc. Therefore, this qualitative and exploratory study identifies the post-covid-19 landscape of the global pharmaceutical industry.

Keywords: covid-19, pharmaceutical, businees, landscape

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Authors: Alina Hamid Bari

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Intellectual Property (IP) policies of a country have a huge impact on the pharmaceutical industry as this industry is all about patents. Developed countries have used IP protection to boost their economy; developing countries are concerned about access to medicine for poor people. U.S. company, Pfizer had a monopoly for 14 years for Lipitor and it all came to end when Pfizer decided to operate in India. This research will focus at the effects of Indian IP policies on USA by comparing Pfizer & Ranbaxy with regards to Trade Related Aspects of Intellectual Property Rights. For this research inductive approach has been used. Main source of material is Annual reports, theory based on academic books and articles along with rulings of court, policy statements and decisions, websites and newspaper articles. SWOT analysis is done for both Pfizer & Ranbaxy. The main comparison was done by doing ratio analysis and analyses of annual reports for the year 2011-2012 for Pfizer and Ranbaxy to see the impact on their profitability. This research concludes that Indian intellectual laws do affect the profitability of the U.S. pharmaceutical industry which can in turn have an impact on the US economy. These days India is only granting patents on products which it feels are deserving of it. So the U.S. companies operating in India have to defend their invention to get a patent. Thus, to operate in India and maintain monopoly in market, US firms have to come up with different strategies.

Keywords: atorvastatin, India, intellectual property, lipitor, Pfizer, pharmaceutical industry, Ranbaxy, TRIPs, U.S.

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Authors: Ivana Brzonova, Asina Fnu, Alena Kubatova, Evguenii Kozliak, Yun Ji

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Bio-decomposition of lignin by Basidiomycetes in the presence of dimethyl sulfoxide (DMSO) was investigated. The addition of 3-5 vol% DMSO to lignin aqueous media significantly increased the lignin solubility based on UV absorbance. After being dissolved in DMSO, the thermal evolution profile also changed significantly, yielding more high-MW organic carbon at the expense of recalcitrant elemental carbon. Medical fungi C. versicolor, G. lucidum and P. pulmonarius, were observed to grow on the lignin in media containing up to 15 vol. % DMSO. Further detailed product characterization by chromatographic methods corroborated these observations, as more low-MW phenolic products were observed with DMSO as a co-solvent. These results may be explained by the high solubility of lignin in DMSO; thus, the addition of DMSO to the medium increases the lignin availability for microorganisms. Some of these low-MW phenolic products host a big potential to be used in medicine. No significant inhibition of enzymatic activity (laccase, MnP, LiP) was observed by the addition of up to 3 vol% DMSO.

Keywords: basidiomycetes, bio-degradation, dimethyl sulfoxide, lignin

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Authors: H. Aksas, S. Boughrara, K. Louhab

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The goal of this study was the use of life cycle assessment (LCA) methodology to assess the environmental impact of pharmaceutical product (four kinds of syrup form and tree kinds of pomade form), which are produced in one leader manufactory in Algeria town that is SAIDAL Company. The impacts generated have evaluated using SimpaPro7.1 with CML92 Method for syrup form and EPD 2007 for pomade form. All impacts evaluated have compared between them, with determination of the compound contributing to each impacts in each case. Data needed to conduct Life Cycle Inventory (LCI) came from this factory, by the collection of theoretical data near the responsible technicians and engineers of the company, the practical data are resulting from the assay of pharmaceutical liquid, obtained at the laboratories of the university. This data represent different raw material imported from European and Asian country necessarily to formulate the drug. Energy used is coming from Algerian resource for the input. Outputs are the result of effluent analysis of this factory with different form (liquid, solid and gas form). All this data (input and output) represent the ecobalance.

Keywords: pharmaceutical product, drug residues, LCA methodology, environmental impacts

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Authors: Hossein Tavallali, Mohammad Ali Karimi, Gohar Deilamy-Rad

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The proposed method for speciation, preconcentration and determination of Fe(II) and Fe(III) in pharmaceutical products was developed using of alumina-coated magnetite nanoparticles (Fe₃O₄/Al₂O₃ NPs) as solid phase extraction (SPE) sorbent in magnetic mixed hemimicell solid phase extraction (MMHSPE) technique followed by flame atomic absorption spectrometry analysis. The procedure is based on complexation of Fe(II) with 1, 10-phenanthroline (OP) as complexing reagent for Fe(II) that immobilized on the modified Fe₃O₄/Al₂O₃ NPs. The extraction and concentration process for pharmaceutical sample was carried out in a single step by mixing the extraction solvent, magnetic adsorbents under ultrasonic action. Then, the adsorbents were isolated from the complicated matrix easily with an external magnetic field. Fe(III) ions determined after facility reduced to Fe(II) by added a proper reduction agent to sample solutions. Compared with traditional methods, the MMHSPE method simplified the operation procedure and reduced the analysis time. Various influencing parameters on the speciation and preconcentration of trace iron, such as pH, sample volume, amount of sorbent, type and concentration of eluent, were studied. Under the optimized operating conditions, the preconcentration factor of the modified nano magnetite for Fe(II) 167 sample was obtained. The detection limits and linear range of this method for iron were 1.0 and 9.0 - 175 ng.mL⁻¹, respectively. Also the relative standard deviation for five replicate determinations of 30.00 ng.mL^-1 Fe²⁺ was 2.3%.

Keywords: Alumina-Coated magnetite nanoparticles, Magnetic Mixed Hemimicell Solid-Phase Extraction, Fe(ΙΙ) and Fe(ΙΙΙ), pharmaceutical sample

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