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Development and Scale Up Of a Chemical Process in Pharmaceutical Industry: A Case Study

Development and Scale Up Of a Chemical Process in Pharmaceutical Industry: A Case Study

Every process has its own significance and one has to study factors which impact to the process and its procedure to be followed. This paper is more concerned of how a process is scaled up from lab scale to pilot plant scale, which is the major step in any industry because moving directly towards manufacturing level consumes time and money. The report introduces about pharmaceutical industry and how it is different from the other industries and provides firsthand experience for all the engineers to explore the equipment, process and unit operations included in it. First aspect of scale up is safety and then comes economy, purity and optimums. It includes the process and its unit operations such as reactors, distillation, filtration, crystallization, drying and the equipment involving these operations. Consequently, the scale up rules, factors influenced strategies and other considerations are observed. To learn and understand the unit process and operations with their importance, a case study taking one of the stages of production is discussed here. Keywords: chemical processes, scaling up, reactors, unit operations, equipments, Safety.
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Is foreignness a source of competitive advantage in the Brazilian pharmaceutical industry?: an exploratory study

Is foreignness a source of competitive advantage in the Brazilian pharmaceutical industry?: an exploratory study

The accelerated growth of pharmaceutical market in Brazil, in the past ten years, attracted and intensified investments from multinational pharmaceutical companies. National companies also invested heavily. The industry matured and competition intensified. However, a company that operates in a foreign, new environment, driven by unfamiliar competitive forces generally encounters additional costs to operate. This phenomenal is called ‘liability of foreignness’ (LOF). Still, the foreign branch of a company may also have unique advantages due to their being foreign, the so called ‘asset of foreignness’ (AOF). Do these theoretical expectations hold in the Brazilian pharmaceutical industry? The paper employs panel data methodology with fixed effects on four regression models for a sample of 22 companies (11 Brazilian subsidiaries of multinationals and 11 national companies) from this industry. Moreover, the models utilized were proved by other researchers, in different markets segments and countries. The findings support the hypothesis formulated by these scholars and suggest the existence of “Liability of Foreignness”.
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Validation of a method for determination of amoxicillin residues applied to cleaning validation process in penicillins pharmaceutical industry.

Validation of a method for determination of amoxicillin residues applied to cleaning validation process in penicillins pharmaceutical industry.

VALIDATION OF A METHOD FOR DETERMINATION OF AMOXICILLIN RESIDUES APPLIED TO CLEANING VALIDATION PROCESS IN PENICILLINS PHARMACEUTICAL INDUSTRY. The aim of this work was the single-laboratory validation of a quantitative method for the determination of amoxicillin residues in support of cleaning control and validation. Linearity was demonstrated between 2.5 and 17.5 µg/mL, without matrix effects. Mean recoveries ranged from 84.00 to 103.74% and the relative standard deviation under repetitivity and within-reproducibility conditions were from 0.58 to 4.20% and from 0.79 to 4.39%, respectively. The theoretical limits of detection and quantiication were 0.133 and 0.442 µg/mL, respectively. The studied method was suitable for cleaning control purpose within good manufacturing practices.
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EXPLORATORY MULTIVARIATE STATISTICAL METHODS APPLIED TO PHARMACEUTICAL INDUSTRY CRM DATA

EXPLORATORY MULTIVARIATE STATISTICAL METHODS APPLIED TO PHARMACEUTICAL INDUSTRY CRM DATA

Provide customer segmentation that can be meaningful to the pharmaceutical company business by enabling the alignment between sales and marketing strategies using the company CRM dataset was also another objective. Currently a good customer segmentation should identify not only the high value customers but segment them by their characteristics (Pepers and Rogers 2006), identify the midsize customers, because usually they demand good service in a reasonable way, pay nearly full price, and are often the most profitable (Kotler and Keller 2007) and identify the low value customers, specifically the ones that the company should not invest promotional effort. A specific segmentation was obtained by using SOMs that is aligned with the business assumptions previously mentioned and make sense in the current hospital market that with the current governmental price pressures and tender negotiations in hospitals is changing to a type of market similar to other industries like the consumer goods. In the U- matrix was possible to identify 6 clusters, 3 clusters belonging to high value customers grouped by their different characteristics (high users of conventional products; high users of innovative drugs; high users of product E), 2 clusters identify the midsize customer segment (being one of the clusters of high users of product E) and one cluster that identifies the low value customers where one unit in the U-Matrix in this cluster identifies the very low value hospitals, that besides the fact they rarely buy products to the company, the patients treated with chemotherapy in these hospitals is almost zero, being hospitals where the oncology potential is almost null and no promotional effort should be spent (table 49 provides the quantitative characteristics of the SOM segmentation), taking in consideration the current high cost of sales force visiting in the pharmaceutical industry, the identification of these customers is very importantant. An important advantage of SOMs is that from the marketing point of view and with the purpose of strategic tactical implementation, component planes can be very useful, because marketing people can visualize graphically which hospitals have the highest impact from the three different factors.
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Evaluating the financial performance of Companies from the Pharmaceutical Industry

Evaluating the financial performance of Companies from the Pharmaceutical Industry

Abstract: The pharmaceutical industry has become a highly competitive environment, which is why performance represents the key element to stay on a market. Evaluating the performance of the economic entities from this sector is of high importance for the management, shareholders, trading partners and creditors. This study focuses on investigating and analyzing the financial statements for 12 drug producing companies in Romania. The analysis is based on data corresponding to the period 2008-2015.

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The simple economics of risk-sharing agreements between the NHS and the pharmaceutical industry

The simple economics of risk-sharing agreements between the NHS and the pharmaceutical industry

Overall, our results argue that the call for a wider use of risk-sharing agreements between the NHS and the pharmaceutical industry, which has been recently met by the NICE decision regarding bortezomib, needs to be assessed with care. Only under a restrictive set of assumptions is it welfare improving, with a crucial as- sumption being fixed prices. Fixed prices means here that pharmaceutical firms want to carry the same price on their product whether the risk-sharing agreement exists, or not. Nonetheless, using as a policy instrument a verification cost paid by the NHS institution, independent of realized outcomes, allows the first-best allocation of patients to the new treatment to be reached.
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Window Analysis and Malmquist Index for Assessing Efficiency in a Pharmaceutical Industry

Window Analysis and Malmquist Index for Assessing Efficiency in a Pharmaceutical Industry

The pharmaceutical industry is an important component of health care systems throughout the world, it is based on the scientific research and development of medicines that prevent or treat diseases and disorders. This industry contributes significantly to the quality and protection of life and helps make the world a better place. Measurement of a production unit-performance is crucial in determining whether it has achieved its objectives or not. Performance measurement is the normal way to deal with internal or external pressures by monitoring and benchmarking a company’s production.
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Astrazeneca and pharmaceutical industry: sector overview and company valuation

Astrazeneca and pharmaceutical industry: sector overview and company valuation

Considering the operating profitability, two important indicators for the industry are the R&D weight on sales and the Selling, General and Administrative expenses (SG&A). Both costs show an increasing trend. The SG&A expenses represent almost 50% of AstraZeneca sales in 2014. Of which 76% was associated with sales and marketing management. Driving these costs were the integration of diabetes division, the launch of Farxiga in the US, Europe and some Emerging Markets, the launch of Bydureon in the US and the preparation of Lynparza and Movantik. High SG&A costs are a feature of the pharmaceutical industry. These expenses are associated with three factors: highly qualified employees; marketing costs; and costs related to regulatory procedures. Highly qualified professionals mean high payrolls. The marketing costs are associated with the promotion and the advertising of the most recently approved medicines to boost their sales. The costs of regulation are also significant because every medicine is submitted to several testing phases and clinical trials.
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A country perspective in exploring the links between hospital pharmacies and pharmaceutical industry: a case study application

A country perspective in exploring the links between hospital pharmacies and pharmaceutical industry: a case study application

Phama Co. develops manufacturers and market generic and in- licensed pharmaceutical products within three core business. The operations span 49 countries and focus on key therapeutic areas such as anti-infectives, cardiovascular, alimentary tract and central nervous system. The injectable business markets 120 branded and non-branded injectable products in 215 dosage, strengths and forms, including 7 in-licensed products. Why Pharma Co. was selected? The 2010 revenue was $731m; by region: 61% MENA, 28% from the US and for Europe and the rest of the world accounts for 10.9%. Selecting it by segment, 23.9% are generics; 21.5% injectable drug products and 54% are branded. It has more than 400 products marketed in 2010. And an operating cash flows over $140.0m. It is the second largest generic injectable supplier by volume in the US with combined market share of more than 15%. Comparing to this introductory section one can expect that it is a good fit of the current pharmaceutical industry scenario. Towards the understanding of their major complaints, semi- structure interviews were applied not only to the company in question, in the main injectable manufacturing and distribution sites, but also to several hospital pharmacies in different countries of action. With this approach it is expected to link both parties in the application of a quality by design (QbD) risk management approach as well as reduce variability and risk of noncompliance. With this approach a more sustainable pharmaceutical supply chain is expected to flourish, reducing waste, an increase of corporate social responsibility.
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Analysis of the importance of drug packaging quality for end users and pharmaceutical industry as a part of the quality management system

Analysis of the importance of drug packaging quality for end users and pharmaceutical industry as a part of the quality management system

In this study, we collected and analyzed information on the importance of drug packaging quality to end users and pharmaceutical industry, as an indicator of the process of traceability and originality of drugs. Two surveys were con- ducted: one among the end users of drugs (252 patients) and the other among professionals working in seven pharmaceutical companies in Serbia. For most end users (82.5%), the quality of the packaging was important, but only 41.8% of them thought that the appearance of the packaging could be an indicator of genuinity of drugs. The existence of the control marks (KM) on drug packaging was not of great importance, since most of the users (86.9%) know its function, but the majority (60.2%) would nevertheless decide to buy the drug without KM. Regard- ing the experts from the pharmaceutical industry, more then two thirds (68.4%) believed that the existance of KM did not contribute to efficient operations. Although a great number of pharmaceutical industry professionals (84.2%) ans- wered that the introduction of GS1 DataMatrix system would allow for complete traceability of the drug from the manufacturer to the end user, only 22.2% of them introduced this system to their products. This study also showed that dom- estic producers did not have a great interest for additional protection (special inks, holograms, special graphics, smart multicolor design, watermark, chemically labeled paper and cardboard, etc.) on their products, given that only 15.8% of them had some kind of additional protection against counterfeiting. Monitoring drug traceability from a manufacturer to end user is achieved by many complex activities regulated by law. A high percentage of responders said they were satis- fied with the functionality of traceability systems used in their companies. As a way to increase the quality of drug packaging and business performance, most responders saw in the continuous improvement of the system of traceability within the company's overall quality management system. For them, a big finan- cial investment in the complete traceability chain was not feasible because of the inability to achieve competitive prices in the market. Since only three of the surveyed companies were part of international chains, these findings open the path for new research that would include more multinational drug manufacturers from the region, in order to fully comprehend the importance of investing in the drug chain traceability and protection against counterfeiting, as a part of total quality management process in the pharmaceutical industry.
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Challenges of analytical chemistry in face of the needs of the pharmaceutical industry.

Challenges of analytical chemistry in face of the needs of the pharmaceutical industry.

CHALLENGES OF ANALYTICAL CHEMISTRY IN FACE OF THE NEEDS OF THE PHARMACEUTICAL INDUSTRY. The development of liquid chromatography-mass spectrometric (LC-MS) techniques in the last few decades has made possible the analysis of trace amounts of analytes from complex matrices. With LC, the analytes of interest can be separated from each other as well as from the interfering matrix, after which they can be reliably identified thanks to the sensitivity and specificity of MS. LC- MS has become an irreplaceable tool for many applications, ranging from the analysis of proteins or pharmaceuticals in biological fluids to the analysis of toxic substances in environmental samples.
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The Importance of Management Control in Monitoring the Pharmaceutical Industry Performance for Competitive Advantage

The Importance of Management Control in Monitoring the Pharmaceutical Industry Performance for Competitive Advantage

Organizational flexibility in pharmaceutical industry refers to the ability of the organization to adapt to changing situations, reflected, for instance, in the level of rigidity of the administrative rules. It ranges from operational, via structural to strategic flexibility. Operational flexibility in pharmaceutical industry refers to the ability of the organization to make routine adaptations to changes in the environment; structural flexibility to adaptive changes; whereas strategic flexibility refers to non-routine proactive changes of the organization and the environment. The extremes are roughly comparable to a mechanistic versus an organic organization, or a bureaucratic versus a normative culture. The control capacity refers to the quality and competence of the research management to achieve adaptations given the level of organizational flexibility. A highly competent research management may reach a high adaptation level, even if the organization is relatively inflexible, whereas a less competent research management may fail, even if the organization as a whole is highly flexible. In this study, „subjective‖ views and judgments of the research management regarding organizational flexibility and control capacity has been combined with „objective‖ measures regarding the innovative process, such as the number of incentives and the frequency of project team meetings.
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Strategic Development Trends in the World Pharmaceutical Industry

Strategic Development Trends in the World Pharmaceutical Industry

tition has changed as well. The previous meaning of internationalization has been replaced by a globalization domain and the previous meaning of the world economy has been replaced by a global economy.  de- fines globalization as ‘Spreading and deepening of companies’ perfor- mance with the target to produce and sell goods or services on mul- tiple markets’ ( ). The later definition of globalization from  () says that ‘More precisely we may define globalization as a developing pattern of international business cooperation, which in- cludes investments, trade and contractory ways of cooperation, and tar- gets the development of products, production, procurement and mar- keting. Such kind of international performance enables the companies to conquer new markets, use their technological and organisational ad- vantages and to lower the costs and risks.’ Globalization is strongly re- lated with the increased mobility and competition. We underline that the main drivers of globalization are transnational or multinational compa- nies. We may argue that the following characteristics are significant for their performance; especially taking into consideration the performances of the multinational companies in the pharmaceutical industry, we aim to research in our paper the following effects:
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Thermal analysis applied to drugs and pharmaceutical formulations in pharmaceutical industry.

Thermal analysis applied to drugs and pharmaceutical formulations in pharmaceutical industry.

THERMAL ANALYSIS APPLIED TO DRUGS AND PHARMACEUTICAL FORMULATIONS IN PHARMACEUTICAL INDUSTRY. Several matters of the pharmaceutical demonstrate the great importance of thermal analysis application, especially TG and DSC for the pharmaceutical industry future, namely: characterization of the drugs with the thermal events deinition, in studies of drug purity, in the polymorphs identiication, in compatibility studies of solid dosage pharmaceutical formulations, in drugs and pharmaceutical formulations thermal stability, and in determination of shelf life for isothermal degradation kinetics by extrapolation using the Arrhenius equation. Thus, the test results obtained from thermal analysis are directly related to the quality of a pharmaceutical product, whether the stability or bioavailability of the pharmaceutical product.
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Challenges of the Brazilian pharmaceutical industry.

Challenges of the Brazilian pharmaceutical industry.

CHALLENGES OF THE BRAZILIAN PHARMACEUTICAL INDUSTRY. The paper traces a panorama of the development of new drugs and hopes to contribute for Brazil to become a player in the discovery of new drugs. Brazil is the sixth world market retail consumer of medicines prone to expansion, has a pharmaceutical industry focused on the production of generics and a very large number of undergraduate courses in Pharmacy. The national industry has grown over the last decade after the Generics Act 9787/99. Despite these positive aspects, a number of bottlenecks prevent Brazilian pharmaceutical industry to invest in the development of new drugs. There are, however, a number of initiatives to reduce the dependence on imported generic drugs. It is a very good start for the development of new pharmaceutical drugs.
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M&A in the chinese pharmaceutical industry: Shanghai Pharma and SIPI/SZXP case study

M&A in the chinese pharmaceutical industry: Shanghai Pharma and SIPI/SZXP case study

M&A of Chinese pharmaceutical industry become increasingly fierce, the Characteristics of Chinese pharmaceutical enterprises merger and acquisition collated by Li Ting and Xu Huaifu (2013) were: smaller scales and more times; mainly in horizontal M&A; government plays a promoting role. But the most outstanding characteristics of mergers and acquisitions of Chinese pharmaceutical companies in recent years is the purpose of the implementation of M&A changed from the scale expansion to the effective resource synergy, to adjust the product structure of the enterprise, to effectively integrate the resources and expand the market position. The same conclusion as in a study from Zhang Yi (2006), the internal cause of the large-scale mergers and acquisitions in Chinese pharmaceutical industry is the developing requirements of scale economy to improve the industry concentration degree; and the external causes are a series of industry consolidation policies and the pressure from foreign investment in the industry, which promotes industry internal integration to enhance resistance capabilities.
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Mandatory disclosure of pharmaceutical industry-funded events for health professionals.

Mandatory disclosure of pharmaceutical industry-funded events for health professionals.

One of the first countries to move towards greater transparency was Austra- lia. The pharmaceutical industry repre- sentative body, Medicines Australia, has a self-regulatory Code of Conduct that sets standards for the ethical marketing and promotion of prescription pharmaceutical products for its member companies. In addition to monitoring of promotional activities, a Code of Conduct Committee adjudicates on complaints regarding phar- maceutical company activities [8]. In 2007, the Australian Competition Tribu- nal placed disclosure requirements on Medicines Australia. It approved that body’s Code of Conduct for industry– professional relationships on the condition that details of every sponsored event, including the costs of any hospitality, were posted on their website [9,10]. Reporting commenced in July 2007 and data are updated six monthly [8].
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PROCESS ORIENTATION AND INFORMATION MANAGEMENT: THE CASE OF ACHIEVING SUCCESS IN THE PHARMACEUTICAL INDUSTRY

PROCESS ORIENTATION AND INFORMATION MANAGEMENT: THE CASE OF ACHIEVING SUCCESS IN THE PHARMACEUTICAL INDUSTRY

The use of IT to enhance business improvement has also meant that organisations start rethinking about the manner in which they conduct their business. This has a bearing on how different industries use IT. The pharmaceutical industry is the focal concern of this paper. This industry has traditionally been extremely functional in its internal organisation, however growing competition and pressures to shorten the life cycle of drug development has kindled interest to assess alternative ways of working. Since the pharmaceutical industry is a very information-intensive business, the use of information systems to support the running of the business is only natural. This paper explores issues related with information management and the implications for managing key operations in the pharmaceutical industry. A move towards process orientation is also identified. The underlying argument is that where a process-oriented approach is chosen, information management in fact plays a key role in ensuring success. It does this largely through integrative actions which, on the one hand overcome the tensions between functional and process approaches, and on the other, facilitate the necessary binding that is implied by a process orientation. The paper is organised into five parts. After a brief introduction, the second section highlights the importance of information in managing business processes. This is followed by establishing a link between business processes and value addition. The various concepts are illustrated by using a case example. Finally, a discussion of some key concepts is presented.
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Gender differences in the workplace: the case of pharmaceutical industry in China

Gender differences in the workplace: the case of pharmaceutical industry in China

Gender’s equality is still an allusive phenomenon in twenty-first century workplaces. Previous studies have suggested that gendered assumptions and organizational factors may contribute to gender’s inequality. However, little research has investigated how individuals make sense of their roles in the workplace in the Chinese context. Drawing on cultural constructions of gender’s roles in organizations, we address three research questions: What are the meanings different actors ascribed to the sales occupation? To what extent are different actors able to (re)construct the dominant culture in the sales context? What are the implications of existing reproduction processes of the dominant culture for the way people experience their lives at the workplace? Through a discourse analysis this article examines the transcripts of thirty narratives on women in sale roles to critically analyse people attitudes to transform the dominant culture in working life. We argue that initiatives sponsored at different organizational ladders, and by both genders, are (un)consciously reproducing sales occupation’s masculine cultures in the pharmaceutical sales industry. The study reveals that while there is a discursive space within the salesforce for gender’s equality, in practice men and women at the workplace engage in masculine status quo, contributing to legitimize unequal relations between the genders in the sales industry in China.
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An Interaction and Network Perspective of Horizontal Relationships in the Portuguese Pharmaceutical Industry

An Interaction and Network Perspective of Horizontal Relationships in the Portuguese Pharmaceutical Industry

According to Eisenhardt (1989, p. 537) “the concept of a population is crucial, because the population defines the set of entities from which the research sample is to be drawn”. The selection of one specific market allows coping with the environmental variation (cf. Eisenhardt, 1989). The research population considered in this study is the set of the existent horizontal relationships between the Portuguese pharmaceutical companies with production facilities in Portugal. It is believed that, despite being possible to reach the entire population, it would be impracticable. Sampling saves not only time, but also money and can even provide a higher overall accuracy, when compared to a full census. Usually, a small number of cases grants more time to the researcher for the design and the piloting of the means adopted to collect data, rather than spending his time collecting data (Saunders et al., 2009).
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