Search results for: pharmaceutical
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 617

Search results for: pharmaceutical

617 Fiqh Challenge in Production of Halal Pharmaceutical Products

Authors: Saadan Man, Razidah Othmanjaludin, Madiha Baharuddin

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Nowadays, the pharmaceutical products are produced through the mixing of active and complex ingredient, naturally or synthetically; and involve extensive use of prohibited animal products. This article studies the challenges faced from fiqh perspective in the production of halal pharmaceutical products which frequently contain impure elements or prohibited animal derivatives according to Islamic law. This study is qualitative which adopts library research as well as field research by conducting series of interviews with the several related parties. The gathered data is analyzed from Sharia perspective by using some instruments especially the principle of Maqasid of Sharia. This study shows that the halal status of pharmaceutical products depends on the three basic elements: the sources of the basic ingredient; the processes involved in three phases of production, i.e., before, during and after; and the possible effects of the products. Various fiqh challenges need to be traversed in producing halal pharmaceutical products including the sources of the ingredients, the logistic process, the tools used, and the procedures of productions. Thus, the whole supply chain of production of pharmaceutical products must be well managed in accordance to the halal standard.

Keywords: fiqh, halal pharmaceutical, pharmaceutical products, Malaysia

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616 A Critical Review of the Success Model of Indian Pharmaceutical Industry

Authors: Ekta Pandey

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The Indian Pharmaceutical Industry is ranked third largest by volume and fourteenth by value. It thus accounts for 10% of world’s production by volume and 1.5% by value according to Department of Pharmaceuticals, Government of India. The industry has shown phenomenal growth over past few years, moving from US $ 1 billion turnover in 1990 to a turnover of around US $30 billion in 2015. The Indian pharmaceutical sector is ranked seventeenth in terms of export value of active pharmaceutical ingredients and dosage forms to more than 200 countries around the globe. It has shown tremendous changes especially after Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. Recognizing the immense potential for growth and its direct impact on Indian economy, it is important to look up the industrial policies adopted since Indian independence which turnaround the Indian pharmaceutical industry. A systematic review of changes in market structure of Indian pharmaceutical industry due to shift in policy regimes is done from 1850 to 2015 using secondary peer reviewed published research work. The aim is to understand the impact of anti-trust laws, intellectual property rights, industry competition acts and regulations are quite crucial in determining effective economic policy and have overall lasting effects on international trade and ties. The proposed paper examines the position of Indian domestic firms relative to multinational pharmaceutical firms tries to throw some light on the growth curve of Indian pharmaceutical sector.

Keywords: active pharmaceutical ingredients, competition act, pharmaceutical industry, TRIPS

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615 An Analysis of Present Supplier Selection Criteria of State Pharmaceutical Corporation (SPC) Sri Lanka: A Case Study

Authors: Gamalath M. B. P. Abeysekara

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Primary objective of any organization is to enhance the bottom line profit. Strategic procurement is one of the prominent aspects in view of receiving this ultimate objective. Strategic procurement is an activity used in each and every organization in their operations. Pharmaceutical procurement is an especially significant task for any organizations, particularly state sector concerned. The whole pharmaceutical procurement requirement of the country is procured through the State Pharmaceutical Corporation (SPC) of Sri Lanka. They follow Pharmaceutical Procurement Guideline of 2006 as the procurement principle. The main objective of this project is to identify the importance of State Pharmaceutical Corporation supplier selection criteria and critical analysis of pharmaceutical procurement procedure. State Pharmaceutical Corporations applied net price, product quality, past performance, and delivery of suppliers’ as main criteria for the selection suppliers. Data collection for this study was taken place through a questionnaire, given to fifty doctors within the Colombo district attached to five main state hospitals. Data analysis is carried out with mean and standard deviation functions. The ultimate outcomes indicated product quality, net price, and delivery of suppliers’ are the most important criteria behind the selection of suppliers. Critical analysis proved State Pharmaceutical Corporation should focus on net price reduction, improving laboratory testing facilities and effective communication between up and down stream of supply chain.

Keywords: government procurement procedure, pharmaceutical procurement supplier selection criteria, importance of SPC supplier selection criteria

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614 Pharmaceutical Science and Development in Drug Research

Authors: Adegoke Yinka Adebayo

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An understanding of the critical product attributes that impact on in vivo performance is key to the production of safe and effective medicines. Thus, a key driver for our research is the development of new basic science and technology underpinning the development of new pharmaceutical products. Research includes the structure and properties of drugs and excipients, biopharmaceutical characterisation, pharmaceutical processing and technology and formulation and analysis.

Keywords: drug discovery, drug development, drug delivery

Procedia PDF Downloads 469
613 Detection of Pharmaceutical Personal Protective Equipment in Video Stream

Authors: Michael Leontiev, Danil Zhilikov, Dmitry Lobanov, Lenar Klimov, Vyacheslav Chertan, Daniel Bobrov, Vladislav Maslov, Vasilii Vologdin, Ksenia Balabaeva

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Pharmaceutical manufacturing is a complex process, where each stage requires a high level of safety and sterility. Personal Protective Equipment (PPE) is used for this purpose. Despite all the measures of control, the human factor (improper PPE wearing) causes numerous losses to human health and material property. This research proposes a solid computer vision system for ensuring safety in pharmaceutical laboratories. For this, we have tested a wide range of state-of-the-art object detection methods. Composing previously obtained results in this sphere with our own approach to this problem, we have reached a high accuracy ([email protected]) ranging from 0.77 up to 0.98 in detecting all the elements of a common set of PPE used in pharmaceutical laboratories. Our system is a step towards safe medicine production.

Keywords: sterility and safety in pharmaceutical development, personal protective equipment, computer vision, object detection, monitoring in pharmaceutical development, PPE

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612 Counterfeit Drugs Prevention in Pharmaceutical Industry with RFID: A Framework Based On Literature Review

Authors: Zeeshan Hamid, Asher Ramish

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The purpose of this paper is to focus on security and safety issues facing by pharmaceutical industry globally when counterfeit drugs are in question. Hence, there is an intense need to secure and authenticate pharmaceutical products in the emerging counterfeit product market. This paper will elaborate the application of radio frequency identification (RFID) in pharmaceutical industry and to identify its key benefits for patient’s care. The benefits are: help to co-ordinate the stream of supplies, accuracy in chains of supplies, maintaining trustworthy information, to manage the operations in appropriate and timely manners and finally deliver the genuine drug to patient. It is discussed that how RFID supported supply chain information sharing (SCIS) helps to combat against counterfeit drugs. And a solution how to tag pharmaceutical products; since, some products prevent RFID implementation in this industry. In this paper, a proposed model for pharma industry distribution suggested to combat against the counterfeit drugs when they are in supply chain.

Keywords: supply chain, RFID, pharmaceutical industry, counterfeit drugs, patients care

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611 Pharmaceutical Innovation in Jordan: KAP Analysis

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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610 Legal Regulation and Critical Analysis for an Effectively Treatment of Pharmaceutical Waste

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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609 Customers' Prescription of Foreign versus Local Brands in the Pharmaceutical Industry of Peshawar, Pakistan

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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608 A Spectrophotometric Method for the Determination of Folic Acid - A Vitamin B9 in Pharmaceutical Dosage Samples

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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607 The Selectivities of Pharmaceutical Spending Containment: Social Profit, Incentivization Games and State Power

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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606 The Role of Stakeholders in the Development of Sustainable Supply Chain Policy Framework in the Upstream Pharmaceutical Industry in Ghana

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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605 European Drug Serialization: Securing the Pharmaceutical Drug Supply Chain from Counterfeiters

Authors: Vikram Chowdhary, Marek Vins

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The profitability of the pharmaceutical drug business has attracted considerable interest, but it also faces significant challenges. Counterfeiters take advantage of the industry's vulnerabilities, which are further exacerbated by the globalization of the market, online trading, and complex supply chains. Governments and organizations worldwide are dedicated to creating a secure environment that ensures a consistent and genuine supply of pharmaceutical products. In 2019, the European authorities implemented regulation EU 2016/161 to strengthen traceability and transparency throughout the entire drug supply chain. This regulation requires the addition of enhanced security features, such as serializing items to the saleable unit level or individual packs. Despite these efforts, the incidents of pharmaceutical counterfeiting continue to rise globally, with regulated territories being particularly affected. This paper examines the effectiveness of the drug serialization system implemented by European authorities. By conducting a systematic literature review, we assess the implementation of drug serialization and explore the potential benefits of integrating emerging digital technologies, such as RFID and Blockchain, to improve traceability and management. The objective is to fortify pharmaceutical supply chains against counterfeiters and manipulators and ensure their security.

Keywords: blockchain, counterfeit drugs, EU drug serialization, pharmaceutical industry, RFID

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604 Resolving Problems Experienced by Involving Patients in the Development of Pharmaceutical Products at Post-Launch Stage of Pharmaceutical Product Development

Authors: Clara T. Fatoye, April Betts, Abayomi Odeyemi, Francis A. Fatoye, Isaac O. Odeyemi

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Background: The post-launch stage is the last stage in the development of a pharmaceutical product. It is important to involve patients in the development of pharmaceutical products at the post-launch stage, as patients are the end-users of pharmaceutical products. It is expected that involving them might ensure an effective working relationship among the various stakeholders. However, involving patients in the development of pharmaceutical products comes with its problems. Hence, this study examined how to resolve problems experienced by involving patients in the developments of pharmaceutical products’ at post-launch consisting of Positioning of pharmaceutical products (POPP), detailing of pharmaceutical products (DOPP) and reimbursement and Formulary Submission (R&FS). Methods: A questionnaire was used for the present study. It was administered at the ISPOR Glasgow 2017 to 104 participants, all of which were professionals from Market access (MA) and health economics and outcomes research (HEOR) backgrounds. They were asked how the issues experienced by patients can be resolved. Participants responded under six domains as follows: communication, cost, effectiveness, external factors, Quality of life (QoL) and safety. Thematic analysis was carried out to identify strategies to resolve issues experienced by patients at the post-launch stage. Results: Three (3) factors cut across at POPP, DOPP, and R&FS that is (external factors, communication and QoL). The first resolution method was an external factor that is, the relationship with stakeholders and policymakers. Communication was also identified as a resolution method that can help to resolve problems experienced by patients at the post-launch stage. The third method was QoL as perceived by the patients based on professionals’ opinions. Other strategies that could be used to resolve problems experienced were the effectiveness of pharmaceutical products at the DOPP level and cost at R&FS. Conclusion: The study showed that focusing on external factors, communication, and patients’ QoL are methods for resolving issues experienced by involving patients at the post-launch stage of pharmaceutical product development. Hence, effective working relationships between patients, policymakers and stakeholders may help to resolve problems experienced at the post-launch stage. Healthcare policymakers are to be aware of these findings as they may help them to put appropriate strategies in place to enhance the involvement of patients in pharmaceutical product development at the post-launch stage, thereby improving the health outcomes of the patients.

Keywords: patients, pharmaceutical products, post-launch stage, quality of life, QoL

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603 Impact of Task Technology Fit on User Effectiveness, Efficiency and Creativity in Iranian Pharmaceutical Oraganizations

Authors: Milad Keshvardoost, Amir Khanlari, Nader Khalesi

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Background: Any firm in the pharmaceutical industry requires efficient and effective management information systems (MIS) to support managerial functions. Purpose: The aim of this study is to investigate the impact of Task-Technology Fit on user effectiveness, efficiency, and creativity in Iranian pharmaceutical companies. Methodology: 345 reliable and validate questionnaires were distributed among selected samples, through the cluster method, to Information system users of eight leading Iranian pharmaceutical companies, based on the likert scale. The proposed model of the article is based on a model with Task technology fit, on user performance with the definition of efficiency, effectiveness, and creativity through mediation effects of perceived usefulness and ease of use. Results: This study confirmed that TTF with definitions of adequacy and compatibility has positive impacts on user performance Conclusion: We concluded that pharmaceutical users of IS, utilizing a system with a precise and intense observation of users' demands, may make facilitation for them to design an exclusive IS framework.

Keywords: information systems, user performance, pharmaceuticals, task technology fit

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602 Production of Biosurfactant by Pseudomonas luteola on a Reject from the Production of Anti-scorpion Serum

Authors: Radia Chemlal, Youcef Hamidi, Nabil Mameri

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This study deals with the production of biosurfactant by the Pseudomonas luteola strain on three different culture media (semi-synthetic medium M1, whey, and pharmaceutical reject) in the presence of gasoil. The monitoring of bacterial growth by measuring the optical density at 600 nm by spectrophotometer and the surface tension clearly showed the ability of Pseudomonas luteola to produce biosurfactants at various conditions of the culture medium. The biosurfactant produced in the pharmaceutical reject medium generated a decrease in the surface tension with a percentage of 19.4% greater than the percentage obtained when using whey which is 7.0%. The pharmaceutical rejection is diluted at various percentages ranging from 5% to 100% in order to study the effect of the concentration on the biosurfactant production. The best result inducing the great reduction of the surface tension value is obtained at the dilution of 30% with the pharmaceutical reject.

Keywords: biosurfactant, pseudomonas luteola, whey, antiscorpionic serum, gas oil

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601 Occurrence of Pharmaceutical Compounds in an Urban Lake

Authors: J. D. Villanueva, N. Peyraube, I. Allan, G. D. Salvosa, M. Reid, C. Harman, K. D. Salvosa, J. M. V. Castro, M. V. O. Espaldon, J. B. Sevilla-Nastor, P. Le Coustumer

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The main objectives of this research are to (1) assess the occurrence of the pharmaceutical compounds and (2) present the environmental challenges posed by the existence of these pharmaceutical compounds in the surface water. These pharmaceuticals were measured in Napindan Lake, Philippines. This lake is not only a major tributary of the Pasig River (an estuary) and Laguna Lake (freshwater). It also joins these two important surface waters of the National Capital Region. Pharmaceutical compounds such as Atenolol, Carbamazepine, and two other over the counter medicines: Cetirizine, and Ibuprofen were measured in Napindan Lake. Atenolol is a beta blocker that helps in lowering hypertensions. Carbamazepine is an anticonvulsant used as treatment for epilepsy and neuropathic pain. Cetirizine is an antihistamine that can relieve allergies. Ibuprofen is a non-steroidal anti-inflammatory drug normally used to relieve pains. Three different climatological conditions with corresponding hydro physico chemical characteristics were considered. First, was during a dry season with a simultaneous dredging. Second was during a transition period from dry to wet season. Finally, the third was during a continuous wet event. Based from the results of the study, most of these pharmaceuticals can be found in Napindan Lake. This is a proof that these pharmaceutical compounds are being released to a natural surface water. Even though climatological conditions were different, concentrations of these pharmaceuticals can still be detected. This implies that there is an incessant supply of these pharmaceutical compounds in Napindan Lake. Chronic exposure to these compounds even at low concentrations can lead to possible environmental and health risks. Given this information and since consistent occurrence of these compounds can be expected, the main challenge, at present, is on how to control the sources of these pharmaceutical compounds. Primarily, there is a need to manage the disposal of the pharmaceutical compounds. Yet, the main question is how to? This study would like to present the challenges and institutional roles in helping manage the pharmaceutical disposals in a developing country like the Philippines.

Keywords: atenolol, carbamazepine, cetirizine, ibuprofen, institutional roles, Napindan lake, pharmaceutical compound disposal management, surface water, urban lake

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600 Treatment of Pharmaceutical Industrial Effluent by Catalytic Ozonation in a Semi-Batch Reactor: Kinetics, Mass Transfer and Improved Biodegradability Studies

Authors: Sameena Malik, Ghosh Prakash, Sandeep Mudliar, Vishal Waindeskar, Atul Vaidya

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In this study, the biodegradability enhancement along with COD color and toxicity removal of pharmaceutical effluent by O₃, O₃/Fe²⁺, O₃/nZVI processes has been evaluated. The nZVI particles were synthesized and characterized by XRD and SEM analysis. Kinetic model was reasonably developed to select the ozone doses to be applied based on the ozonation kinetic and mass transfer coefficient values. Nano catalytic ozonation process (O₃/nZVI) effectively enhanced the biodegradability (BI=BOD₅/COD) of pharmaceutical effluent up to 0.63 from 0.18 of control with a COD, color and toxicity removal of 62.3%, 93%, and 75% respectively compared to O₃, O₃/Fe²⁺ pretreatment processes. From the GC-MS analysis, 8 foremost organic compounds were predominantly detected in the pharmaceutical effluent. The disappearance of the corresponding GC-MS spectral peaks during catalyzed ozonation process indicated the degradation of the effluent. The changes in the FTIR spectra confirms the transformation/destruction of the organic compounds present in the effluent to new compounds. Subsequent aerobic biodegradation of pretreated effluent resulted in biodegradation rate enhancement by 5.31, 2.97, and 1.22 times for O₃, O₃/Fe²⁺ and O₃/nZVI processes respectively.

Keywords: iron nanoparticles, pharmaceutical effluent, ozonation, kinetics, mass transfer

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599 Role of Information and Communication Technology in Pharmaceutical Innovation: Case of Firms in Developing Countries

Authors: Ilham Benali, Nasser Hajji, Nawfel Acha

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The pharmaceutical sector is ongoing different constraints related to the Research and Development (R&D) costs, the patents extinction, the demand pressing, the regulatory requirement and the generics development, which drive leading firms in the sector to undergo technological change and to shift to biotechnological paradigm. Based on a large literature review, we present a background of innovation trajectory in pharmaceutical industry and reasons behind this technological transformation. Then we investigate the role that Information and Communication Technology (ICT) is playing in this revolution. In order to situate pharmaceutical firms in developing countries in this trajectory, and to examine the degree of their involvement in the innovation process, we did not find any previous empirical work or sources generating gathered data that allow us to analyze this phenomenon. Therefore, and for the case of Morocco, we tried to do it from scratch by gathering relevant data of the last five years from different sources. As a result, only about 4% of all innovative drugs that have access to the local market in the mentioned period are made locally which substantiates that the industrial model in pharmaceutical sector in developing countries is based on the 'license model'. Finally, we present another alternative, based on ICT use and big data tools that can allow developing countries to shift from status of simple consumers to active actors in the innovation process.

Keywords: biotechnologies, developing countries, innovation, information and communication technology, pharmaceutical firms

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598 Enhancing Predictive Accuracy in Pharmaceutical Sales through an Ensemble Kernel Gaussian Process Regression Approach

Authors: Shahin Mirshekari, Mohammadreza Moradi, Hossein Jafari, Mehdi Jafari, Mohammad Ensaf

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This research employs Gaussian Process Regression (GPR) with an ensemble kernel, integrating Exponential Squared, Revised Matern, and Rational Quadratic kernels to analyze pharmaceutical sales data. Bayesian optimization was used to identify optimal kernel weights: 0.76 for Exponential Squared, 0.21 for Revised Matern, and 0.13 for Rational Quadratic. The ensemble kernel demonstrated superior performance in predictive accuracy, achieving an R² score near 1.0, and significantly lower values in MSE, MAE, and RMSE. These findings highlight the efficacy of ensemble kernels in GPR for predictive analytics in complex pharmaceutical sales datasets.

Keywords: Gaussian process regression, ensemble kernels, bayesian optimization, pharmaceutical sales analysis, time series forecasting, data analysis

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597 The Role of Social and Technical Lean Implementation in Improving Operational Performance: Insights from the Pharmaceutical Industry

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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596 Assessment of Physical, Chemical and Radionuclides Concentrations in Pharamasucal Industrial Wastewater Effluents in Amman, Jordan

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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595 Linking Market Performance to Exploration and Exploitation in The Pharmaceutical Industry

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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594 Cross-Sectional Analysis of Sustainability Activities in the Pharmaceutical Companies

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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593 Impact of Financial Performance Indicators on Share Price of Listed Pharmaceutical Companies in India

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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592 Determinants of Profitability in Indian Pharmaceutical Firms in the New Intellectual Property Rights Regime

Authors: Shilpi Tyagi, D. K. Nauriyal

Abstract:

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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591 Regime under Trade Related Intellectual Property Rights Agreement 1994 and Its Impacts on Health in Pakistan: A Case Study of Pharmaceutical Patents

Authors: Muhammad Danyal Khan

Abstract:

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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590 Operational Excellence Performance in Pharmaceutical Quality Control Labs: An Empirical Investigation of the Effectiveness and Efficiency Relation

Authors: Stephan Koehler, Thomas Friedli

Abstract:

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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589 The Effect of Foreign Owned Firms and Licensed Manufacturing Agreements on Innovation: Case of Pharmaceutical Firms in Developing Countries

Authors: Ilham Benali, Nasser Hajji, Nawfal Acha

Abstract:

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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588 Corporate Life Cycle and Corporate Social Responsibility Performance: Empirical Evidence from Pharmaceutical Industry in China

Authors: Jing (Claire) LI

Abstract:

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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