Doctors and pharmaceutical industry.

Science.gov (United States)

Beran, Roy G

2009-09-01

The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine.

Identifying and prioritizing industry-level competitiveness factors: evidence from pharmaceutical market.

Science.gov (United States)

Shabaninejad, Hosein; Mehralian, Gholamhossein; Rashidian, Arash; Baratimarnani, Ahmad; Rasekh, Hamid Reza

2014-04-03

Pharmaceutical industry is knowledge-intensive and highly globalized, in both developed and developing countries. On the other hand, if companies want to survive, they should be able to compete well in both domestic and international markets. The main purpose of this paper is therefore to develop and prioritize key factors affecting companies' competitiveness in pharmaceutical industry. Based on an extensive literature review, a valid and reliable questionnaire was designed, which was later filled up by participants from the industry. To prioritize the key factors, we used the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS). The results revealed that human capital and macro-level policies were two key factors placed at the highest rank in respect of their effects on the competitiveness considering the industry-level in pharmaceutical area. This study provides fundamental evidence for policymakers and managers in pharma context to enable them formulating better polices to be proactively competitive and responsive to the markets' needs.

Risk Management in the Pharmaceutical Industry in Slovenian Companies

Directory of Open Access Journals (Sweden)

Bucalo Nina

2017-05-01

Full Text Available The pharmaceutical industry is one of the most competitive businesses in the world. Supply chain in this industry has been directed towards the production of large batches to avoid lack of supplies, and the achievement of regulatory requirements, at the cost of high level of inventory, higher costs and inventory write-off due to expiration or other reasons. In recent years this industry is facing major changes and challenges such as intense globalization processes, increased competition and innovations in technologies, which has broadened and deepened risks in supply chain.

Global gene mining and the pharmaceutical industry

International Nuclear Information System (INIS)

Knudsen, Lisbeth E.

2005-01-01

Worldwide efforts are ongoing in optimizing medical treatment by searching for the right medicine at the right dose for the individual. Metabolism is regulated by polymorphisms, which may be tested by relatively simple SNP analysis, however requiring DNA from the test individuals. Target genes for the efficiency of a given medicine or predisposition of a given disease are also subject to population studies, e.g., in Iceland, Estonia, Sweden, etc. For hypothesis testing and generation, several bio-banks with samples from patients and healthy persons within the pharmaceutical industry have been established during the past 10 years. Thus, more than 100,000 samples are stored in the freezers of either the pharmaceutical companies or their contractual partners at universities and test institutions. Ethical issues related to data protection of the individuals providing samples to bio-banks are several: nature and extent of information prior to consent, coverage of the consent given by the study person, labeling and storage of the sample and data (coded or anonymized). In general, genetic test data, once obtained, are permanent and cannot be changed. The test data may imply information that is not beneficial to the patient and his/her family (e.g., employment opportunities, insurance, etc.). Furthermore, there may be a long latency between the analysis of the genetic test and the clinical expression of the disease and wide differences in the disease patterns. Consequently, information about some genetic test data may stigmatize patients leading to poor quality of life. This has raised the issue of 'genetic exceptionalism' justifying specific regulation of use of genetic information. Discussions on how to handle sampling and data are ongoing within the industry and the regulatory sphere, the European Agency for the Evaluation of Medicinal Products (EMEA) having issued a position paper, the Council for International Organizations of Medical Sciences (CIOMS) having a working

Marketing orientation in pharmaceutical industry

Directory of Open Access Journals (Sweden)

Prošić Danica

2006-01-01

Full Text Available Pharmaceutical companies are major stakeholders in the global health agenda Virtually all drugs used by patients in Europe reach markets through the promotion tactics of a small number of corporations with a tremendous impact on global health. The sector is both fast growing and highly profitable. Effective marketing strategies are a crucial ingredient in making sure pharmaceutical products and profits flow in a virtuous cycle. At first glance, the relationship between doctors and drug companies, as well as advertising practices for over-the-counter medication, appears tightly regulated. According to many consumer organizations, drug promotion in Europe today can be characterized as nice and friendly marketing. This refers to the creation of a false sense of trust that consumers associate with branded pharmaceutical products, as a result of pharmaceutical marketing efforts disguised as genuine corporate responsibility.

[The pharmaceutical industry in the industrial chemical group: the National Union of Chemical-Pharmaceutical Laboratories (1919-1936)].

Science.gov (United States)

Nozal, Raúl Rodríquez

2011-01-01

The pharmaceutical industry associations, as it happened with other businesses, had a significant rise during the dictatorship of Primo de Rivera and II Republic. The 'Cámara Nacional de Industrias Químicas', in Barcelona, represented the national chemical industry to its ultimate assimilation by the 'Organización Sindical' in 1939. In this association, matters relating to pharmaceutical products -- which we will especially deal with in this work -- were managed by the 'Unión Nacional de Laboratorios Químico-Farmacéuticos', which defended the interests of pharmaceutical companies in the presence of government authorities, using the resources and mechanisms also managed by business pressure groups. The inclusion of industrial pharmacy in the Chemical lobby separated the pharmaceutical industry from traditional exercise and its corporate environment. this created ups and downs, conflicts of interests and finally, love and hate relationships with their colleagues of the pharmacy work placement and, of course, with the association that represented them: the 'Unión Farmacéutica Nacional'.

A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran.

Science.gov (United States)

Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Ebadifard Azar, Farbod; Nabilo, Bahram; Abolghasem Gorji, Hassan; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

2015-04-23

Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world's greatest businesses. The aim of this study was to analyze Iran's comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran's trade in this field. To identify Iran's comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran's intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran's Customs Administration, Iran's pharmaceutical Statistics, World Bank and International Trade Center. The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world's total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran's pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran's intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade.

Financial risk of the biotech industry versus the pharmaceutical industry.

Science.gov (United States)

Golec, Joseph; Vernon, John A

2009-01-01

The biotech industry now accounts for a substantial and growing proportion of total R&D spending on new medicines. However, compared with the pharmaceutical industry, the biotech industry is financially fragile. This article illustrates the financial fragility of the biotech and pharmaceutical industries in the US and the implications of this fragility for the effects that government regulation could have on biotech firms. Graphical analysis and statistical tests were used to show how the biotech industry differs from the pharmaceutical industry. The two industries' characteristics were measured and compared, along with various measures of firms' financial risk and sensitivity to government regulation. Data from firms' financial statements provided accounting-based measures and firms' stock returns applied to a multifactor asset pricing model provided financial market measures. The biotech industry was by far the most research-intensive industry in the US, averaging 38% R&D intensity (ratio of R&D spending to total firm assets) over the past 25 years, compared with an average of 25% for the pharmaceutical industry and 3% for all other industries. Biotech firms exhibited lower and more volatile profits and higher market-related and size-related risk, and they suffered more negative stock returns in response to threatened government price regulation. Biotech firms' financial risks increase their costs of capital and make them more sensitive to government regulations that affect their financial prospects. As biotech products grow to represent a larger share of new medicines, general stock market conditions and government regulations could have a greater impact on the level of innovation of new medicines.

Quality management benchmarking: FDA compliance in pharmaceutical industry.

Science.gov (United States)

Jochem, Roland; Landgraf, Katja

2010-01-01

By analyzing and comparing industry and business best practice, processes can be optimized and become more successful mainly because efficiency and competitiveness increase. This paper aims to focus on some examples. Case studies are used to show knowledge exchange in the pharmaceutical industry. Best practice solutions were identified in two companies using a benchmarking method and five-stage model. Despite large administrations, there is much potential regarding business process organization. This project makes it possible for participants to fully understand their business processes. The benchmarking method gives an opportunity to critically analyze value chains (a string of companies or players working together to satisfy market demands for a special product). Knowledge exchange is interesting for companies that like to be global players. Benchmarking supports information exchange and improves competitive ability between different enterprises. Findings suggest that the five-stage model improves efficiency and effectiveness. Furthermore, the model increases the chances for reaching targets. The method gives security to partners that did not have benchmarking experience. The study identifies new quality management procedures. Process management and especially benchmarking is shown to support pharmaceutical industry improvements.

Evaluating the impact of Brexit on the pharmaceutical industry.

Science.gov (United States)

Kazzazi, Fawz; Pollard, Cleo; Tern, Paul; Ayuso-Garcia, Alejandro; Gillespie, Jack; Thomsen, Inesa

2017-01-01

The UK Pharmaceutical Industry is arguably one of the most important industries to consider in the negotiations following the Brexit vote. Providing tens of thousands of jobs and billions in tax revenue and research investment, the importance of this industry cannot be understated. At stake is the global leadership in the sector, which produces some of the field's most influential basic science and translation work. However, interruptions and losses may occur at multiple levels, affecting patients, researchers, universities, companies and government. By understanding the current state of pharmaceutical sector, the potential effect of leaving the European Union (EU) on this successful industry can be better understood. This paper aims to address the priorities for negotiations by collating the analyses of professionals in the field, leading companies and non-EU member states. A government healthcare policy advisor and Chief Science Officer (CSO) for a major pharmaceutical firm were consulted to scope the paper. In these discussions, five key areas were identified: contribution, legislative processes, regulatory processes, research and outcomes, commercial risk. Multiple search engines were utilised for selecting relevant material, predominantly PubMed and Google Scholar. To supplement this information, Government documents were located using the "GOV.UK" publications tool, and interviews and commentaries were found through the Google News search function. With thorough investigation of the literature, we propose four foundations in the advancement of negotiations. These prioritise: negotiation of 'associated country' status, bilaterally favourable trade agreements, minimal interruption to regulatory bodies and special protection for the movement of workforce in the life sciences industry.

A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran

Science.gov (United States)

Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Azar, Farbod Ebadifard; Nabilo, Bahram; Gorji, Hassan Abolghasem; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

2015-01-01

Background: Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world’s greatest businesses. The aim of this study was to analyze Iran’s comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran’s trade in this field. Methods: To identify Iran’s comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran’s intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran’s Customs Administration, Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Results: The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world’s total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran’s pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran’s intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. Conclusions: The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade. PMID:26153184

[The attitude of physicians regarding the promotion strategies of the pharmaceutical industry].

Science.gov (United States)

Castresana, Leonardo; Mejia, Raul; Aznar, Mireya

2005-01-01

Pharmaceutical companies invest large sums of money promoting their products. They use a multifaceted approach to drug promotion, incorporating techniques such as hospital and office detailing by pharmaceutical representatives. Although these practices are commonly used, little has been published about the attitude of physicians concerning their interaction with the pharmaceutical industry. We performed a cross sectional anonymous survey to identify the extent of and attitudes towards the relationship between the physicians and the pharmaceutical industry and its representatives with its impact on the knowledge, attitude and behavior of the physicians. Internists, cardiologists and dermatologists who work in ambulatory settings from private and public hospitals in Buenos Aires city participated in this study, 44% were female, 35% residents, 65% staff physicians, averaging 41 years of age. Of these, 86% receive medical samples frecuently, 39% desk gifts, 19% invitations to congresses and 12% free lunches. Half of the doctors believe that receiving benefits from the pharmaceutical industry has an influence on medical prescription, but only 27% accept this as influential in their own prescriptions. Residents consider, more frequently than others, that these activities affect their decisions, (42% vs. 18% p = 0.007, global 30%). Most of the participants consider appropriate receiving these benefits, although 35% think that they affect the final price of medications. In conclusion, there is a high level of interaction between the pharmaceutical industry and our medical population. Although the latter recognize the influence of these interactions on prescriptions and the elevation of the cost of the final product, they find it appropriate to receive benefits.

Determinants of Iran's BilateralIntra-industry Trade in Pharmaceutical Industry.

Science.gov (United States)

Aghlmand, Siamak; Rahimi, Bahlol; Farrokh-Eslamlou, Hamidreza; Nabilou, Bahram; Yusefzadeh, Hassan

2018-01-01

Among non-oil and in trade arena, drug has always been strategic importance and most government especially industrialized countries pay special attention to its production and trade issues. Thus, having a comprehensive view from economic perspective to this section is essential for suggesting intervention. This was a descriptive-analytical and panel study. In this study, gravity model is used to estimate Iran's bilateral intra-industry trade in pharmaceutical products in the 2001-2012 periods. To illustrate the extent of pharmaceutical's intra-industry trade between Iran and its major trading partners, the explanatory variables of market size, income, factor endowments, distance, cultural contributions, and similarities and also special trade arrangements have been applied. Analysis of factors affecting Iran's bilateral intra-industry trade in pharmaceutical industry showed that the average GDP and cultural similarities had a significant positive impact on Iran's bilateral IIT, while the difference in GDP has a negative and significant effect. Coefficients obtained for the geographical distance and the average ratio of total capital to the labor force is not consistent with theoretical expectations. Special trade arrangements did not have significant impact on the extent of bilateral intra-industry trade between Iran and its trading partners. The knowledge of the intra-industry trade between Iran and its trade partners make integration between the countries. Factors affecting this type of trade pattern underlie its development in trade relationship. Therefore, the findings of this study would be useful in helping to develop and implement policies for the expansion of the pharmaceutical trade.

A new e-beam application in the pharmaceutical industry

International Nuclear Information System (INIS)

Sadat, Theo; Malcolm, Fiona

2005-01-01

The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a 'miniature' low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned

Quality Systems Implementation in the Pharmaceutical Industry

African Journals Online (AJOL)

Nafiisah

quality standards imposed on local pharmaceutical manufacturers. Keywords: Quality/ .... GMP is concerned with both production and quality control. It is aimed ... in the European pharmaceutical industry in designing their quality systems:.

[Chinese medicine industry 4.0：advancing digital pharmaceutical manufacture toward intelligent pharmaceutical manufacture].

Science.gov (United States)

Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li

2016-01-01

A perspective analysis on the technological innovation in pharmaceutical engineering of Chinese medicine unveils a vision on "Future Factory" of Chinese medicine industry in mind. The strategy as well as the technical roadmap of "Chinese medicine industry 4.0" is proposed, with the projection of related core technology system. It is clarified that the technical development path of Chinese medicine industry from digital manufacture to intelligent manufacture. On the basis of precisely defining technical terms such as process control, on-line detection and process quality monitoring for Chinese medicine manufacture, the technical concepts and characteristics of intelligent pharmaceutical manufacture as well as digital pharmaceutical manufacture are elaborated. Promoting wide applications of digital manufacturing technology of Chinese medicine is strongly recommended. Through completely informationized manufacturing processes and multi-discipline cluster innovation, intelligent manufacturing technology of Chinese medicine should be developed, which would provide a new driving force for Chinese medicine industry in technology upgrade, product quality enhancement and efficiency improvement. Copyright© by the Chinese Pharmaceutical Association.

Public Innovation Policy in the Pharmaceutical Industry: the Cases of the EU and USA

Directory of Open Access Journals (Sweden)

Z. A. Mamedyarov

2017-01-01

Full Text Available Purpose: the main purpose of this article was to study the modern tools of the public innovation policy in the global pharmaceutical industry (US and EU cases, which is one of the most knowledge-intensive sectors of the global economy. During the study, it was necessary to achieve the following objectives: to identify main components of the innovation policy in the sector, to consider the role of intellectual property protection, measures of innovation support, regulatory control and other factors, and, also, to identify comparative characteristics of innovation processes within the US and the EU pharmaceutical sector. Methods: this article is based on a qualitative comparative study of the US and EU innovation policy in the pharmaceutical industry. Industryoriented innovation support measures (i.e. levels of private and public financing have been quantitatively analyzed, including the evaluation of the levels of R&D productivity; also, a comparative study of the pharma patent statistics in the leading countries have been performed. This article highlights the problems of intellectual property protection, which remains an important source of financial stability for major pharma companies being the basis for new innovation agenda. Low R&D productivity and high costs of new innovative drugs together emphasize the significance of the analysis of current innovation processes within the pharmaceutical industry, and could open the way for building more effective managerial and business processes. Results: the global pharmaceutical industry today is under thorough control of government regulators and civil society organizations seeking to improve mechanisms of the drugs distribution, in order to make drugs more accessible, safe and clean. This high regulation level impedes innovation within existing pharma business models, and leads to high costs of the newest drugs. The study revealed that successful pharmaceutical innovation today requires

Proceed to the innovation in the pharmaceutical industry. The case of Spain

Directory of Open Access Journals (Sweden)

Aída Salazar García

2015-01-01

Full Text Available This article explores sectors identified innovation in Spanish pharmaceutical companies. It also considers domestic firms and foreign subsidiaries in the country. The analysis covers the period 2009 to 2011 for a population N=200 affiliates at that time Farmaindustria and Plan Profarma. The work involved a search of useful information on the websites of pharmaceutical companies based in Spain statically describes the innovative profile of the Spanish pharmaceutical through descriptive statistical analysis. Thus a foundation for documenting the results in a database in order to get a picture with determination on the behavior of Spanish pharmaceutical sector and possible trends is created.The high content of literary contribution on the pharmaceutical sector is expressed in a globalized national and international level, rejecting data and information that could provide signals threat or opportunity regarding short period time, and which in turn are comparable to other years since the Spanish pharmaceutical industry is constituted by companies of foreign origin (50.5% and domestic capital (49.5%. Of the latter SMEs are the protagonists of small innovations established in Madrid and Barcelona mainly.

CURRENT TRENDS AND PROSPECTS OF THE RUSSIAN PHARMACEUTICAL INDUSTRY AND THE FOREIGN EXPERIENCE

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Z. A. Mamedyarov

2017-01-01

Full Text Available Purpose: the purpose of this article is to study the current state of the pharmaceutical industry in Russia, to identify trends in Russian pharmaceutical market, and to provide preliminary analysis of the state support policy for pharmaceuticals in Russia, focusing on the federal target program "Pharma-2020".Methods: the study is based on a quantitative study of the characteristics and trends of the Russian pharmaceutical market. The emphasis was put on the period 2008–2017. The volume of the market, the structure of imports and exports are considered, and expenditures under the federal program "Pharma-2020" are studied. A qualitative comparative comparison with the tendencies of the global development of the industry is conducted and recommendations are made on further stimulating the growth of the pharma industry in Russia.Results: in the past 5 years, the pharmaceutical industry in Russia did receive special attention from the government, significant funds have been allocated for to support domestic producers, and import substitution policies have been launched. Financial results of the industry show slight improvement in a number of indicators: the market share of domestic medicines is growing, the generics production increased, production standards became tighter controlled. Nevertheless, Russia remains on the periphery of the world pharmaceutical science, import retains two thirds of the market share by value, while innovative novel drugs are now launched primarily by MNEs from the US and the EU.Conclusions and relevance: the challenges and development factors of Russia's pharmaceutical industry identified in this research require effective regulatory tools. First of all, it is necessary to reduce the gap between Russia and the developed countries in the R&D standards and their market implementation. Statistical data has showed the progress in the production of drugs from the VED list (Vital and Essential Drugs, but it is necessary to

Micro factors bringing the pharmaceutical industry to a seismic shaking a qualitative research.

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Dierks, Raphaela Marie Louisa; Bruyère, Olivier; Reginster, Jean-Yves

2017-06-01

Due to changing macro and micro factors, expiring patents and falling net income, pharmaceutical companies need to rethink their vertical business model. The trend shows cross-sectorial partnerships and consolidation to remain and compete on the market. Areas covered: Quantitative research interviewing a target group of 25 key executives from small, mid and large global pharmaceutical companies rounded with qualitative literature research completing the analysis. Expert commentary: Uncertainty in the industry due to changing external factors i.e. pricing pressures, regulations or an economic slowdown, slowing down innovations and new drug outcomes. Pharmaceutical companies understand the existing hurdles, and are critically optimistic implementing new business models. Also, various stakeholders are included in the value chain due to their growing importance. During the next years, the industry will be restructured from volume towards value, and only pharmaceutical companies' clairaudient and reciprocate to the changes with an out-off the box thinking will be able to resist on the market. Small biotech companies should focus on research, and big pharmaceutical companies entering at development focusing on the process until the distribution. This execution business recommendation would enable the best know-how at the right point, mitigating the risk and enhancing the patient outcomes.

ECONOMIC AND FINANCIAL IMPLICATIONS OF THE PHARMACEUTICAL INDUSTRY IN ROMANIA

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Georgiana Daniela Minculete Piko

2014-09-01

Full Text Available In the wake of the financial crisis, most industries witnessed an economic downturn also boosted by the austerity measures imposed by the state. The pharmaceutical sector is one of the few sectors that followed an upward trend. Although the economic and financial crisis has long taken hold of the entire world, the domino theory did not apply to this industry; instead, the “butterfly effect” became evident. The phrase refers to the fact that the wings of a butterfly create small changes that may finally alter the route of certain elements. In the pharmaceutical industry, minor changes in research and development finally led to spectacular innovations. At present, there are no such big investments in research and development in Romania as there are in Europe; yet, due to mergers and acquisitions between Romanian and foreign companies, the pharmaceutical sector in Romania significantly contributes to the creation of added value in terms of economic development. The added value of the pharmaceutical industry in our country has increased significantly in recent years. The purpose of this article is to highlight the financial and economic significance of the pharmaceutical industry in Romania. This industry is one with an average degree of concentration; thus, the average liquidity and solvency indicators in this sector were calculated with a view to emphasizing its financial independence. The findings of this research indicate a high level of financial independence in this industry, as pharmaceutical companies are able to meet payment deadlines. This study highlights the importance of such an industry in times of economic crisis, the financial stability of the pharmaceutical sector reinforcing the need for massive investment in research and development.

Healthcare systems, the State, and innovation in the pharmaceutical industry

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Ignacio José Godinho Delgado

Full Text Available Abstract: This article discusses the relations between healthcare systems and the pharmaceutical industry, focusing on state support for pharmaceutical innovation. The study highlights the experiences of the United States, United Kingdom, and Germany, developed countries and paradigms of modern health systems (liberal, universal, and corporatist, in addition to Japan, a case of successful catching up. The study also emphasizes the experiences of China, India, and Brazil, large developing countries that have tried different catching up strategies, with diverse histories and profiles in their healthcare systems and pharmaceutical industries. Finally, with a focus on state forms of support for health research, the article addresses the mechanisms for linkage between health systems and the pharmaceutical industry, evaluating the possibilities of Brazil strengthening a virtuous interaction, favoring the expansion and consolidation of the Brazilian health system - universal but segmented ‒ and the affirmation of the innovative national pharmaceutical industry.

RFID in the pharmaceutical industry: addressing counterfeits with technology.

Science.gov (United States)

Taylor, Douglas

2014-11-01

The use of Radio Frequency Identification (RFID) in the pharmaceutical industry has grown in recent years. The technology has matured from its specialized tracking and retail uses to a systemic part of supply chain management in international pharmaceutical production and distribution. Counterfeit drugs, however, remain a significant challenge for governments, pharmaceutical companies, clinicians, and patients and the use of RFID to track these compounds represents an opportunity for development. This paper discusses the medical, technological, and economic factors that support widespread adoption of RFID technology in the pharmaceutical industry in an effort to prevent counterfeit medicines from harming patients and brand equity.

Mergers and innovation in the pharmaceutical industry.

Science.gov (United States)

Comanor, William S; Scherer, F M

2013-01-01

Conflicting trends confound the pharmaceutical industry. The productivity of pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made industry outcomes worse? Copyright © 2012 Elsevier B.V. All rights reserved.

ETHICAL ASPECTS OF THE COOPERATION BETWEEN PHYSICIAN AND PHARMACEUTICAL INDUSTRY

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Jože Drinovec

2001-09-01

Full Text Available Background. It is not possible to isolated ethical aspects and norms in the work of physician from the professional and scientific ones. The physician will not act contrary to ethical principles if he will work for the interests of the patient and in accordance with scientific knowledge.Present situation and possible solutions. Every physician, especially if working in university institution is co-operating with pharmaceutical industry, at least he is makes the prescriptions and chooses one drug of the possible ones. There are also other aspects of co-operation: clinical trials, writing expertise and lectures at scientific meetings, sponsored by pharmaceutical industry. There are guidelines and codex in Western countries for more than ten years, which regulate the relation between physician and pharmaceutical industry. The most important ones are those from World Health Organisation, European Federation of Pharmaceutical Industries’ Associations’, and International Federation of Pharmaceutical Manufacturers Associations’. Scientific independence of lecturers and writers is tried to be achieved by disclosure of relevant financial relation with pharmaceutical corporation in advance.Conclusions. Physician working with pharmaceutical industry has o follow the guidelines of international professional associations. He/she has to be independent relaying only upon scientific and professional principles seeing primary the benefit of the patient.

The future of the pharmaceutical, biological and medical device industry

Directory of Open Access Journals (Sweden)

Burgess LJ

2011-09-01

Full Text Available Lesley J Burgess, Marli TerblancheTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and University of Stellenbosch, Parow, South AfricaAbstract: Numerous factors contribute to the declining pharmaceutical industry on the one hand and the rapidly growing generic industry together with the growing importance of medical devices and biologicals on the other. It is clear that the pharmaceutical industry is going to undergo a change in the next decade in order to meet the current challenges facing it and ultimately sustain its profitability and growth. This paper aims to identify a number of fairly obvious trends that are likely to have a significant impact on the product development pipeline in the next decade. It is more than clear that the current production pipeline for pharmaceutical, biotechnology and medical device industries is no longer sustainable and that urgent interventions are required in order to maintain its current level of profitability.Keywords: pharmaceutical industry, personalized medicine, trends, generics, biotechnology

Scientific misconduct, the pharmaceutical industry, and the tragedy of institutions.

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Cohen-Kohler, Jillian Clare; Esmail, Laura C

2007-09-01

This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing countries how without sufficient controls, there is a risk that corporate behaviour will transgress ethical boundaries. We submit that there is a critical need for urgent drug regulatory reform. There must be robust regulatory structures in place which enforce corporate governance mechanisms to ensure that pharmaceutical companies maintain ethical standards in drug research and development and the marketing of pharmaceuticals. What is also needed is for the pharmaceutical industry to adopt authentic "corporate social responsibility" policies as current policies and practices are insufficient.

New Product Introduction in the Pharmaceutical Industry

DEFF Research Database (Denmark)

Hansen, Klaus Reinholdt Nyhuus

Due to the limited time of the monopoly provided by patent protection that is used for recouping the R&D investment, pharmaceutical companies focus on keeping time-to-market for new products as short as possible. This process is however getting more uncertain, as the outcome of clinical trials...... is unknown and negotiations with authorities have become harder, making market introduction more difficult. This dissertation treats the new product introduction process in the pharmaceutical industry from an operations perspective. The overarching aim of this dissertation is to improve the planning...... uncertainty and several important industry characteristics. The model is used to gain several insights on the use of risk packaging and on keeping time-to-market short. As capacity in secondary pharmaceutical production is critical for product availability, a capacity planning model for a new drug delivery...

Determinants of Iran’s Bilateral Intra-industry Trade in Pharmaceutical Industry

Science.gov (United States)

Aghlmand, Siamak; Rahimi, Bahlol; Farrokh-Eslamlou, Hamidreza; Nabilou, Bahram; Yusefzadeh, Hassan

2018-01-01

Among non-oil and in trade arena, drug has always been strategic importance and most government especially industrialized countries pay special attention to its production and trade issues. Thus, having a comprehensive view from economic perspective to this section is essential for suggesting intervention. This was a descriptive-analytical and panel study. In this study, gravity model is used to estimate Iran’s bilateral intra-industry trade in pharmaceutical products in the 2001-2012 periods. To illustrate the extent of pharmaceutical’s intra-industry trade between Iran and its major trading partners, the explanatory variables of market size, income, factor endowments, distance, cultural contributions, and similarities and also special trade arrangements have been applied. Analysis of factors affecting Iran’s bilateral intra-industry trade in pharmaceutical industry showed that the average GDP and cultural similarities had a significant positive impact on Iran’s bilateral IIT, while the difference in GDP has a negative and significant effect. Coefficients obtained for the geographical distance and the average ratio of total capital to the labor force is not consistent with theoretical expectations. Special trade arrangements did not have significant impact on the extent of bilateral intra-industry trade between Iran and its trading partners. The knowledge of the intra-industry trade between Iran and its trade partners make integration between the countries. Factors affecting this type of trade pattern underlie its development in trade relationship. Therefore, the findings of this study would be useful in helping to develop and implement policies for the expansion of the pharmaceutical trade. PMID:29881438

Uneasy subjects: medical students' conflicts over the pharmaceutical industry.

Science.gov (United States)

Holloway, Kelly

2014-08-01

In this article I report on an investigation of the pharmaceutical industry's influence in medical education. Findings are based on fifty semi-structured interviews with medical students in the United States and Canada conducted between 2010 and 2013. Participant responses support the survey-based literature demonstrating that there is clear and pervasive influence of the pharmaceutical industry in medical education. They also challenge the theory that medical students feel entitled to industry gifts and uncritically accept industry presence. I investigate how medical students who are critical of the pharmaceutical industry negotiate its presence in the course of their medical education. Findings suggest that these participants do not simply absorb industry presence, but interpret it and respond in complex ways. Participants were uncomfortable with industry influence throughout their medical training and found multifaceted ways to resist. They struggled with power relations in medical training and the prevailing notion that industry presence is a normal part of medical education. I argue that this pervasive norm of industry presence is located in neoliberal structural transformations within and outside both education and medicine. The idea that industry presence is normal and inevitable represents a challenge for students who are critical of industry. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

Pharmaceutical industry marketing: understanding its impact on women's health.

Science.gov (United States)

Sufrin, Carolyn B; Ross, Joseph S

2008-09-01

The delivery of modern health care entails significant involvement from the pharmaceutical industry, including developing and manufacturing drugs. However, the industry also has tremendous influence on the practice of medicine through its considerable marketing efforts, both to patients through direct to consumer advertising, and to physicians through detailing, providing samples, continuing medical education, and other efforts. This article will review the role that pharmaceutical marketing plays in health care, and the substantial evidence surrounding its influence on patient and physician behaviors, with additional discussion of the medical device industry, all with particular attention to women's health. Understanding the effects of pharmaceutical marketing on women's health, through discussion of relevant examples-including oral contraceptive pills, drugs for premenstrual dysphoric disorder, Pap smear cytology techniques, and neonatal herpes prophylaxis-will help ensure that women receive unbiased, evidenced-based care. We will conclude with a discussion of guidelines that have been proposed by professional organizations, policy makers, and universities, to assist physicians in managing exposure to pharmaceutical marketing.

The Influence of Emerging Markets on the Pharmaceutical Industry.

Science.gov (United States)

Tannoury, Maya; Attieh, Zouhair

2017-01-01

, and oncologic diseases has been observed in emerging markets, mimicking their Western counterparts. The incidence of diabetes and oncologic diseases is expected to grow by 20% or more by 2030. This shows that pharmaceutical industries will also be able to market their global products in these new countries. Conquering emerging markets can be challenging for industries. These challenges can be grouped into 3 categories: infrastructure development, cost-containment policies, and value-driven drug evaluation. Top strategies considered to overcome these challenges include adequate tailoring and a gain in market.

Quality in the pharmaceutical industry - A literature review.

Science.gov (United States)

Haleem, Reham M; Salem, Maissa Y; Fatahallah, Faten A; Abdelfattah, Laila E

2015-10-01

The aim of this study is to:a.Highlight the most important guidelines and practices of quality in the pharmaceutical industry.b.Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices. A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. The content of those sources was analyzed and the following themes were identified:a.Research theme 1: Guidelines of the pharmaceutical quality.b.Research theme 2: General practices recently applied in the pharmaceutical industry. The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. In research theme II; the following topics were identified and reviewed: quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP. Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, it was noticed that there is an abundant number of papers and articles that explain the general guidelines and practices but the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices. It is recommended that the literature would invest more in the area of application and significance of guidelines and practices. New case studies should be done to prove the feasibility of such practices.

APPROACHES TO IMPLEMENTATION OF AN INTEGRATED MANAGEMENT SYSTEM IN THE PHARMACEUTICAL INDUSTRY. GALENICAL PHARMACEUTICAL PRODUCTION

Directory of Open Access Journals (Sweden)

Ershova Elena Vladimirovna

2015-10-01

Full Text Available This article reviews the issues associated with development of an integrated quality management system and its implementation into a galenical pharmaceutical company. Recently, the Russian pharmaceutical industry has been developing extensively: pharmaceutical clusters are being formed, new and innovative technologies are being developed. For the enterprises producing galenical pharmaceutical products, which feature low prices and a high level of competition, development and implementation of management systems is a way to prove their competitiveness. The purpose of this article is to review the architecture and the key elements of integrated management systems for pharmaceutical enterprises, develop an integrated management system in terms of the upcoming revision of ISO 9001:2015, as well as to describe the benefits of implementation of such systems. The presented approach is the result of an educational project implemented within the framework of the MBA programme in "Master of Business Administration (MBA" in the Federal State Budgetary Educational Institution of Continuing Professional Education Pastukhov State Academy of Industrial Management.

Global pharmaceutical regulation: the challenge of integration for developing states.

Science.gov (United States)

Pezzola, Anthony; Sweet, Cassandra M

2016-12-20

This paper has set out to map the state of pharmaceutical regulation in the developing world through the construction of cross-national indices drawing from World Health Organization data. The last two decades have been characterized by deep changes for the pharmaceutical sector, including the complete transformation of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active ingredient suppliers in China and India. Although the rules for ownership of medicine have been set and globally implemented, we know surprisingly little about how the standards for market entrance and regulation of pharmaceutical products have changed at the national level. How standardized are national pharmaceutical market systems? Do we find homogeneity or variation across the developing world? Are their patterns for understanding why some countries have moved closer to one global norm for pharmaceutical regulation and others have developed hybrid models for oversight of this sector? Access to medicine is a core tool in public health. This paper gauges the levels of standards in public and private generics markets for developing countries building on national-level pharmaceutical market surveys for 78 countries to offer three indicators of market oversight: State Regulatory Infrastructure, Monitoring the Private Market and Public Quality Control. Identifying the different variables that affect a state's institutional capacity and current standard level offers new insights to the state of pharmaceuticals in the developing world. It is notable that there are very few (none at the time of this paper) studies that map out the new global terrain for pharmaceutical regulation in the post-TRIPS context. This paper uses item response theory to develop original indicators of pharmaceutical regulation. We find remarkable resistance to the implementation of global pharmaceutical norms for quality standards in developing states and in

The Identification Of Realistic Export Opportunities For The South African Pharmaceutical Industry

OpenAIRE

Wilma Viviers; Martie Lubbe; Ermie Steenkamp; Douglas Olivier

2014-01-01

South Africa needs to advance its industrialisation process and diversify its exports if it is to enhance its global competitiveness ranking and meaningfully tackle the double scourge of unemployment and poverty. The pharmaceutical industry makes a significant contribution to the countrys economy, and has a growing international footprint. However, export activity is largely centred on Southern and Eastern Africa, while markets in other parts of the world remain largely untapped. A lo...

A vision of the pharmaceutical industry.

Science.gov (United States)

Muñio, S

1998-01-01

As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing.

Analysis of International Mergers and Acquisitions in the Pharmaceutical Industry

Directory of Open Access Journals (Sweden)

Božo Matić

2011-07-01

Full Text Available There are numerous researches which analyze mergers and acquisitions, but most of them do not focus on a certain industry, but their sample considers companies from different industries. This paper focuses on mergers and acquisitions in the pharmaceutical industry. It is assumed that pharmaceutical companies with no experience in mergers and acquisitions achieve better results in relatively small and domestic mergers and acquisitions while pharmaceutical companies with greater experience in mergers and acquisitions are successful even in bigger and international mergers and acquisitions. Bigger mergers and acquisitions and international mergers and acquisitions are more risky for the companies so lack of experience in mergers and acquisitions additionally increases risks during the process of mergers and acquisitions. On average, such increase of the risk results in lower returns for stock owners of pharmaceutical companies.

The pharmaceutical industry in the industrial chemical group: The National Union of Chemical-Pharmaceutical Laboratories (1919-1936

Directory of Open Access Journals (Sweden)

Rodríguez Nozal, Raúl

2011-12-01

Full Text Available The pharmaceutical industry associations, as it happened with other businesses, had a significant rise during the dictatorship of Primo de Rivera and II Republic. The Cámara Nacional de Industrias Químicas, in Barcelona, represented the national chemical industry to its ultimate assimilation by the Organización Sindical in 1939. In this association, matters relating to pharmaceutical products —which we will specially deal with in this work— were managed by the Unión Nacional de Laboratorios Químico-Farmacéuticos, which defended the interests of pharmaceutical companies in the presence of government authorities, using the resources and mechanisms also managed by business pressure groups. The inclusion of industrial pharmacy in the Chemical lobby separated the pharmaceutical industry from traditional exercise and its corporate environment. This created ups and downs, conflicts of interests and finally, love and hate relationships with their colleagues of the pharmacy work placement and, of course, with the association that represented them: the Unión Farmacéutica Nacional.

El asociacionismo farmacéutico industrial, al igual que ocurriera con otras actividades empresariales, experimentó un notable auge durante la Dictadura de Primo de Rivera y la II República. La Cámara Nacional de Industrias Químicas, desde Barcelona, representó a la industria química nacional hasta su asimilación definitiva por la Organización Sindical franquista, en 1939. Dentro de esta asociación, los asuntos relacionados con los productos farmacéuticos, a los que prestaremos especial atención en este trabajo, fueron gestionados por la Unión Nacional de Laboratorios Químico- Farmacéuticos, que defendió los intereses de los productores de medicamentos industriales ante las autoridades gubernamentales, utilizando para ello recursos y mecanismos también manejados por otros grupos empresariales de presión. La inclusión de la farmacia industrial

The impact of TRIPS on innovation and exports: a case study of the pharmaceutical industry in India.

Science.gov (United States)

Malhotra, Prabodh

2008-01-01

Currently, there is a debate on what impact the implementation of the Trade Related Aspects of Intellectual Property Rights (TRIPS) in India would have on its pharmaceutical industry and health care. The debate hinges primarily on two major questions. First, will the new patent regime provide an impetus for innovation in the pharmaceutical industry? Second, how far will India's pharmaceutical exports of copied versions of patented drugs to developing countries be restricted under the new regime? The first question seeks to find out if TRIPS will increase India's innovative capabilities to fill the current vacuum to develop drugs for tropical diseases. The large multinational companies (MNCs) that dominate the global pharmaceutical industry have no interest in commercial ventures that have little potential for great returns on investment. The second question attempts to find a solution to the lack of access to medicine in most developing countries. Indian manufacturers' supply of reverse-engineered drugs, which cost only a fraction of the prices charged by MNCs, may be coming to an end under the new regime. Against this backdrop, this article attempts to analyse the impact of strengthening intellectual property rights in India.

Metrology in Pharmaceutical Industry - A Case Study

International Nuclear Information System (INIS)

Yuvamoto, Priscila D.; Fermam, Ricardo K. S.; Nascimento, Elizabeth S.

2016-01-01

Metrology is recognized by improving production process, increasing the productivity, giving more reliability to the measurements and consequently, it impacts in the economy of a country. Pharmaceutical area developed GMP (Good Manufacture Practice) requeriments, with no introduction of metrological concepts. However, due to Nanomedicines, it is expected this approach and the consequent positive results. The aim of this work is to verify the level of metrology implementation in a Brazilian pharmaceutical industry, using a case study. The purpose is a better mutual comprehension by both areas, acting together and governmental support to robustness of Brazilian pharmaceutical area. (paper)

Models for open innovation in the pharmaceutical industry.

Science.gov (United States)

Schuhmacher, Alexander; Germann, Paul-Georg; Trill, Henning; Gassmann, Oliver

2013-12-01

The nature of the pharmaceutical industry is such that the main driver for its growth is innovation. In view of the vast challenges that the industry has been facing for several years and, in particular, how to manage stagnating research and development (R&D) productivity, pharmaceutical companies have opened their R&D organizations to external innovation. Here, we identify and characterize four new types of open innovator, which we call 'knowledge creator', 'knowledge integrator', 'knowledge translator' and 'knowledge leverager', and which describe current open R&D models. Copyright © 2013 Elsevier Ltd. All rights reserved.

New Product Development in the Pharmaceutical Industry: Evidence from a generic market.

Science.gov (United States)

Yousefi, Nazila; Mehralian, Gholamhossein; Rasekh, Hamid Reza; Yousefi, Mina

2017-01-01

In today's competitive world, there are several strategies to deal with the fast changing environment, among which New product development (NPD) is a common strategy. However, almost half of the resources that companies devote to NPD are spent on products that may fail. This issue is particularly highlighted in the pharmaceutical industry mainly because of a long development-time, low success rate, high capital requirement, and market uncertainty. This study identifies critical success factors of NPD based on the relevant literatures and expert opinions in Iranian pharmaceutical industry, then prioritizes them using the methodology of multiple criteria decision making (MCDM) through analyzing 50 filled questionnaires structured based on the AHP (Analytical Hierarchy Process) approach. Although the NPD success factors seem the same in both generic and bio-generic pharmaceutical industries, the underlying factors and related sub-factors show the different importance in these two industries. However, this study reveal that, the company capabilities is the most important factor affecting new product development success in both pharmaceutical generic and bio-generic industry. The results of this study contribute to create baseline information for pharmaceutical industry especially Iranian pharmaceutical companies to be more effective in budget allocation on improving NPD success factors so that they can boost the success rate of NPD more effectively.

The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s

Directory of Open Access Journals (Sweden)

Kyu-Hwan SIHN

2015-12-01

Full Text Available After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The

[The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s].

Science.gov (United States)

Sihn, Kyu-Hwan

2015-12-01

After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA) marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The market for

Comparative analysis of pharmaceuticals versus industrial chemicals acute aquatic toxicity classification according to the United Nations classification system for chemicals. Assessment of the (Q)SAR predictability of pharmaceuticals acute aquatic toxicity and their predominant acute toxic mode-of-action

DEFF Research Database (Denmark)

Sanderson, Hans; Thomsen, Marianne

2009-01-01

data. Pharmaceuticals were found to be more frequent than industrial chemicals in GHS category III. Acute toxicity was predictable (>92%) using a generic (Q)SAR ((Quantitative) Structure Activity Relationship) suggesting a narcotic MOA. Analysis of model prediction error suggests that 68...... a comprehensive database based on OECD's standardized measured ecotoxicological data and to evaluate if there is generally cause of greater concern with regards to pharmaceutical aquatic toxicological profiles relative to industrial chemicals. Comparisons were based upon aquatic ecotoxicity classification under...... the United Nations Global Harmonized System for classification and labeling of chemicals (GHS). Moreover, we statistically explored whether the predominant mode-of-action (MOA) for pharmaceuticals is narcosis. We found 275 pharmaceuticals with 569 acute aquatic effect data; 23 pharmaceuticals had chronic...

Quality in the pharmaceutical industry – A literature review

Science.gov (United States)

Haleem, Reham M.; Salem, Maissa Y.; Fatahallah, Faten A.; Abdelfattah, Laila E.

2013-01-01

Objectives The aim of this study is to:a.Highlight the most important guidelines and practices of quality in the pharmaceutical industry.b.Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices. Design A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. The content of those sources was analyzed and the following themes were identified:a.Research theme 1: Guidelines of the pharmaceutical quality.b.Research theme 2: General practices recently applied in the pharmaceutical industry. Main outcome measures The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. In research theme II; the following topics were identified and reviewed: quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP. Results Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, it was noticed that there is an abundant number of papers and articles that explain the general guidelines and practices but the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices. Conclusions It is recommended that the literature would invest more in the area of application and significance of guidelines and practices. New case studies should be done to prove the feasibility of such practices. PMID:26594110

Cleaner production at pharmaceutical industry: first steps assessment

Directory of Open Access Journals (Sweden)

Edilaine Conceição Rezende

2015-12-01

Full Text Available The Cleaner Production (CP is an environmental management system effective to comply the environmental obligations and promote sustainable development of enterprises. In this study, the implementing possibilities of CP practices were evaluated to pharmaceutical industry, through prior identification procedures for Pharmaceutical Manufacturing Practices. The study was conducted in a scientific and health care institution, which produces pharmaceutical drugs and makes assistance for public health. The production process was evaluated and made a survey of the main points of waste and sewage generations in each stage, in order to diagnose the measures of CP established and propose new actions. Thus, by using this tool, it was possible to demonstrate the reduction of environmental impacts associated with pharmaceutical production. The Pharmaceutical Manufacturing Practices also contributed to the implementation of measures CP, preserving the final product quality, and generating environmental and economic benefits.

78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Science.gov (United States)

2013-04-26

...] Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food... announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical... on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This...

Prospective of Transformation of Current Models of the Global Pharmaceutical Market

Directory of Open Access Journals (Sweden)

Yuriy Solodkovskyy

2012-02-01

Full Text Available This article thoroughly analyzes the current state of the global pharmaceutical market, defines the key factors for its development and outlines the promising areas of transformation of existing business models of top companies. The forecasted data relating to the market development until 2015 have been investigated. The global, market, technological and organizational factors of transformation of modern model of the global pharmaceutical market have been identified.

Psychiatric Resident and Faculty Views on and Interactions with the Pharmaceutical Industry

Science.gov (United States)

Misra, Sahana; Ganzini, Linda; Keepers, George

2010-01-01

Objective: Sales visits, or detailing, by pharmaceutical industry representatives at academic institutions has been increasingly criticized. The authors surveyed psychiatric residents and faculty members on their views and interactions with representatives of the pharmaceutical industry. Methods: In 2007, a 46-item online survey measuring…

Update on the Pharmaceutical Industry | McDonald | Southern ...

African Journals Online (AJOL)

The Sunday Times Business Times published a supplement on the pharmaceutical industry on 30 November 2003. This has been an extremely dynamic environment and one that will be affected by impending legislative change. The objective of the survey was to provide some insight into the current status of the industry ...

Development paths of China's agricultural Pharmaceutical industry under Eco-agriculture background.

Science.gov (United States)

Li, Jinkai; Gong, Liutang; Ji, Xi; Zhang, Jin; Miao, Pei

2014-07-01

Using pesticides has double effects. On one hand, it contributes to pests control and regulates the growth of crops; On the other hand, it does harm to the environment. To develop ecological agriculture should not only emphasize the output level of agriculture to pursuit of economic efficiency, but also need to keep the ecological environment protected and focus on the social benefits during the development of the industry. As a large agricultural country in the world, China is vigorously promoting the development of ecological agriculture, which is bound to put forward to developing the pesticide industry and green ecological development requirements to promote the transformation and upgrading of agricultural pharmaceutical industry. This paper discusses the mechanism of pesticide pollution on the ecological environment and analyzes China's agricultural problems in the pharmaceutical industry. Then study on the development of Chinese green pesticides and try to find the proper paths of agricultural pharmaceutical to achieve industrial upgrading.

Importance of marketing management in the world pfarmaceutical industry

Directory of Open Access Journals (Sweden)

Dragan Kesič

2008-07-01

Full Text Available The world pharmaceutical industry has changed tremendously in the last decade. Globalization processes reinforce a consolidation of the world pharmaceutical industry. Mergers and acquisitions prevail more and more as a strategic orientation of numerous world pharmaceutical companies. In our research we found out that marketing management has been playing an increasingly important or even a crucial role in day-today activities and strategic business operations of the world pharmaceutical companies. We may point out that a rapid consolidation of the world pharmaceutical industry is definitely a market-driven process, one conditioned by typical strategic marketing management issues, such as a lack of brand new products, intense competitiveness, globalization processes, increased global marketing and sales activities, changing structure of global competitors as well as a furious fight for global market shares and customers’ loyalty. We estimate that marketing management is to play an even more important and, especially, the top priority strategic role in the future globalization and concentration processes of the world pharmaceutical industry. Some experiences and lessons from the global perspective of the world pharmaceutical industry could also be useful to the management of pharmaceutical companies in the transition countries of the Central and Eastern European region. Taking into consideration the current market position of these companies, some marketing management guidelines for their marketing management policies and strategies could be suggested. We conclude that underestimating, or even complete neglect of the importance of marketing management issues may pose the greatest threat to the future strategic orientation and performance of the world pharmaceutical industry.

Update on the Pharmaceutical Industry | McDonald | Southern ...

African Journals Online (AJOL)

... Times published a supplement on the pharmaceutical industry on 30 November 2003. This has been an extremely dynamic environment and one that will be affected by impending legislative change. The objective of the survey was to provide some insight into the current status of the industry – special attention was paid ...

Pharmaceutical portfolio management: global disease burden and corporate performance metrics.

Science.gov (United States)

Daems, Rutger; Maes, Edith; Mehra, Maneesha; Carroll, Benjamin; Thomas, Adrian

2014-09-01

Biopharmaceutical companies face multiple external pressures. Shareholders demand a profitable company while governments, nongovernmental third parties, and the public at large expect a commitment to improving health in developed and, in particular, emerging economies. Current industry commercial models are inadequate for assessing opportunities in emerging economies where disease and market data are highly limited. The purpose of this article was to define a conceptual framework and build an analytic decision-making tool to assess and enhance a company's global portfolio while balancing its business needs with broader social expectations. Through a case-study methodology, we explore the relationship between business and social parameters associated with pharmaceutical innovation in three distinct disease areas. The global burden of disease-based theoretical framework using disability-adjusted life-years provides an overview of the burden associated with particular diseases. The social return on investment is expressed as disability-adjusted life-years averted as a result of the particular pharmaceutical innovation. Simultaneously, the business return on investment captures the research and development costs and projects revenues in terms of a profitability index. The proposed framework can assist companies as they strive to meet the medical needs of populations around the world for decades to come. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

[The pharmaceutical industry in scandal: Mercury or Aesculapius?].

Science.gov (United States)

Offerhaus, L

2004-12-18

During the last decade public sympathy for the pharmaceutical industry has gradually been eroded because of excessive protectionism and profit margins. Its reputation as a healthy, profitable and prosperous industry has recently been seriously damaged by several errors of judgement. Data from early trials proved to be less positive than expected. The responsible drug manufacturers decided to cover the results up. So far the pharmaceutical industry has managed to weather the criticism, but recently a multitude of damaging data was published by an unexpected outsider. Angell, a former editor in chief of one of the most respected, peer-reviewed medical journals in the world, the New England Journal of Medicine, decided to collect such data and to analyze them critically. She also used this analysis to draw up recommendations for improving of what she regarded as an unhealthy situation. The book gained bestseller status on the American market and received much praise from reviewers. Although quickly denounced by the industry as controversial and excessively negative, it contains a lot of data, opinions and conclusions that also apply directly to the European situation.

Electrochemical treatment of pharmaceutical and industrial wastewater by anodic oxidation

International Nuclear Information System (INIS)

Menapace, H. M.; Fellerer, M.; Treschnitzer, M.

2009-01-01

In modern medicine pharmaceuticals play a decisive role: because of an increased life expectancy and intensive care medicine an increasing amount of pharmaceuticals is produced. thus these substances are consumed in a mass of tons per year in industrialized countries. Wastewater effluents from sewage treatment plants (STP) are important point sources for residues of pharmaceuticals and complexing agents in the aquatic environment. For this reason a research project, which started in December 2006, was established to eliminate pharmaceutical substances and complexing agents found in wastewater as micropollutants. (Author)

[Innovation in pharmaceutical and health biotechnology industries: challenges for a virtuous agenda].

Science.gov (United States)

Vargas, Marco; Gadelha, Carlos Augusto Grabois; Costa, Laís Silveira; Maldonado, José

2012-12-01

Pharmaceutical and biotechnology industries comprise a major production subsystem of the health industrial complex in Brazil. It stands out for both its economic importance and its prominent role in developing new technologies in strategic areas. Strengthening the local production of generic drugs in the last decade has significantly increased the number of Brazilian companies in the local pharmaceutical market and has been an important turning point for this industry's growth. However, there remain major structural bottlenecks both in terms of production and continuous innovation. These bottlenecks reveal the high vulnerability of the Brazilian National Health System and point to the need of public policies that promote strengthening the production base and innovation in the pharmaceutical industry and that at the same time meet health-related social demands in health in Brazil.

76 FR 64945 - Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

Science.gov (United States)

2011-10-19

... FEDERAL TRADE COMMISSION [File No. 111 0166] Teva Pharmaceutical Industries Ltd. and Cephalon, Inc... Consent Orders (``Consent Agreement'') from Teva Pharmaceutical Industries Ltd. (``Teva'') and Cephalon... Pharmaceutical, Inc. (``Par'') all of Teva's rights and assets relating to its generic transmucosal fentanyl...

Recent trends in laboratory automation in the pharmaceutical industry.

Science.gov (United States)

Rutherford, M L; Stinger, T

2001-05-01

The impact of robotics and automation on the pharmaceutical industry over the last two decades has been significant. In the last ten years, the emphasis of laboratory automation has shifted from the support of manufactured products and quality control of laboratory applications, to research and development. This shift has been the direct result of an increased emphasis on the identification, development and eventual marketing of innovative new products. In this article, we will briefly identify and discuss some of the current trends in laboratory automation in the pharmaceutical industry as they apply to research and development, including screening, sample management, combinatorial chemistry, ADME/Tox and pharmacokinetics.

[Legislation on the pharmaceutical industry in Morocco during the French protectorate 1912 - 1956].

Science.gov (United States)

Nhaili, Hicham; Taoufik, Jamal

2015-06-01

In Morocco, the pharmaceutical industry was born with the French protectorate. She knew a great evolution: from a limited production for local needs, it became an important activity, organized to export pharmaceutical patent medicines. This article revisits the birth and history of this industry during the protectorate. It refers to the situation at the time by listing some examples of active establishments and some specialities marketed. It also aims to increase knowledge about the industry and provides an overview of the situation of practitioners remembering the texts governing the profession. Based on the available literature, we examined and analyzed the arrangements related to the establishment, organization and evolution of the pharmaceutical industry.

Long-Term Collaboration Network Based on ClinicalTrials.gov Database in the Pharmaceutical Industry

Directory of Open Access Journals (Sweden)

Heyoung Yang

2018-01-01

Full Text Available Increasing costs, risks, and productivity problems in the pharmaceutical industry are important recent issues in the biomedical field. Open innovation is proposed as a solution to these issues. However, little statistical analysis related to collaboration in the pharmaceutical industry has been conducted so far. Meanwhile, not many cases have analyzed the clinical trials database, even though it is the information source with the widest coverage for the pharmaceutical industry. The purpose of this study is to test the clinical trials information as a probe for observing the status of the collaboration network and open innovation in the pharmaceutical industry. This study applied the social network analysis method to clinical trials data from 1980 to 2016 in ClinicalTrials.gov. Data were divided into four time periods—1980s, 1990s, 2000s, and 2010s—and the collaboration network was constructed for each time period. The characteristic of each network was investigated. The types of agencies participating in the clinical trials were classified as a university, national institute, company, or other, and the major players in the collaboration networks were identified. This study showed some phenomena related to the pharmaceutical industry that could provide clues to policymakers about open innovation. If follow-up studies were conducted, the utilization of the clinical trial database could be further expanded, which is expected to help open innovation in the pharmaceutical industry.

"But doctors do it...": nurses' views of gifts and information from the pharmaceutical industry.

Science.gov (United States)

Jutel, Annemarie; Menkes, David B

2009-06-01

Most nurses, like their physician counterparts, lack education regarding pharmaceutical marketing strategies, and little is known of their beliefs and practices regarding this industry. Nurses are increasingly targeted by pharmaceutical companies as they become more involved in prescription and as policies restrict pharmaceutical companies' contact with physicians. To assess nurses' beliefs and reported practices concerning pharmaceutical marketing and sponsorship strategies. We conducted parallel Web- and paper-based surveys of a sample of senior registered nurses employed by government-funded health boards in 2 regions of New Zealand to explore their contact with the pharmaceutical industry as well as their beliefs and practices regarding information, gifts, and sponsorship provided by pharmaceutical companies. Returns were tested using Fisher's exact test to determine consistency in response between regions. Results for key outcome variables, including attitude toward the value of industry-derived information, were analyzed by region and in aggregate. Most nurses had contact with pharmaceutical sales representatives (69/106), accepted gifts from representatives (79/105), and believed information from the pharmaceutical industry probably improved their practice (71/106). Half believed that they would be able to detect misleading information if it were present, and 35% believed that accepting gifts and sponsorship was ethically acceptable. We found positive associations between the belief that information from the industry improved practice and reported acceptance of conference funding (OR 3.63; 95% CI 1.41 to 11.55), free food (OR 3.24; 95% CI 2.03 to 7.55), or gifts (OR 3.52; 95% CI 1.38 to 8.95). Nurses generally acknowledge the presence of pharmaceutical marketing in the hospital and the ethical challenges it presents; nonetheless, they also generally accept marketing gifts and may underestimate both the ethical challenges and their own susceptibility to

LEAN AND SIX SIGMA CONCEPTS APPLICATION IN PHARMACEUTICAL INDUSTRY

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Katarina Pavlović

2012-03-01

Full Text Available LEAN thinking and Six Sigma have been utilized by manufacturing industries to decrease cost and improve quality and productivity by reducing variation and production defects [1]. Because of the dramatic successes in manufacturing, there is rising interest among companies in the pharmaceutical industry, which chooses to implement LEAN in order to accomplish such goals as decreased wait time to release product to the market, reduce production waste, and improve communication with end users and raize quality level both in the production and in testing laboratories. In this article, basics of LEAN and Six Sigma are presented and suggestion was given for application of their concepts in pharmaceutical industry together with harmonization with legal regulation represented by requirements Good Manufacturing Practice (cGMP, in order to work "smarter", more cost-effectively and avoid was ting time and other resources.

LEAN AND SIX SIGMA CONCEPTS - APPLICATION IN PHARMACEUTICAL INDUSTRY

Directory of Open Access Journals (Sweden)

Katarina Pavlović

2011-06-01

Full Text Available LEAN thinking and Six Sigma have been utilized by manufacturing industries to decrease cost and improve quality and productivity by reducing variation and production defects. Because of the dramatic successes in manufacturing, there is rising interest among companies in the pharmaceutical industry, which choose to implement LEAN in order to accomplish such goals as decreased wait time to release product to the market, reduce production waste, improve communication with end users and raise quality level both in the production and in testing laboratories. In this article, basics of LEAN and Six Sigma are presented and suggestion was given for application of their concepts in pharmaceutical industry together with harmonization with legal regulation represented by requirements Good Manufacturing Practice (cGMP, in order to work "smarter", more cost- effectively and avoid wasting time and other resources.

Environmental management practices in the Lebanese pharmaceutical industries: implementation strategies and challenges.

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Massoud, May A; Makarem, N; Ramadan, W; Nakkash, R

2015-03-01

This research attempts to provide an understanding of the Lebanese pharmaceutical industries' environmental management strategies, priorities, and perceptions as well as drivers, barriers, and incentives regarding the implementation of the voluntary ISO 14001 Environmental Management System. Accordingly, a semistructured in-depth interview was conducted with the pharmaceutical industries. The findings revealed a significant lack of knowledge about the standard among the industries. The main perceived drivers for adopting the ISO 14001 are improving the companies' image and overcoming international trade. The main perceived barriers for acquiring the standard are the lack of government support and the fact that ISO 14001 is not being legally required or enforced by the government. Moreover, results revealed that adopting the ISO 14001 standard is not perceived as a priority for the Lebanese pharmaceutical industries. Although the cost of certification was not considered as a barrier for the implementation of ISO 14001, the majority of the pharmaceutical industries are neither interested nor willing to adopt the Standard if they are not exposed to any regulatory pressure or external demand. They are more concerned with quality and safety issues with the most adopted international standard among the industries being the ISO 9001 quality management system. This study highlights the aspect that financial barriers are not always the hurdles for implementing environmental management strategies in developing countries and underscores the need for regulatory frameworks and enforcement.

The case for entrepreneurship in R&D in the pharmaceutical industry.

Science.gov (United States)

Douglas, Frank L; Narayanan, V K; Mitchell, Lesa; Litan, Robert E

2010-09-01

A lack of entrepreneurial behaviour has often been highlighted as a contributor to the decline in the research and development (R&D) productivity of the pharmaceutical industry. Here, we present an assessment of entrepreneurship in the industry, based on interviews with 26 former and current leaders of R&D departments at major pharmaceutical and biotechnology companies. Factors are highlighted that could be important in promoting entrepreneurial behaviour, which might serve as a catalyst for revitalizing R&D productivity.

Applied statistics in the pharmaceutical industry with case studies using S-PLUS

CERN Document Server

Krause, Andreas

2001-01-01

The purpose of this book is to provide a general guide to statistical methods used in the pharmaceutical industry, and to illustrate how to use S-PLUS to implement these methods. Specifically, the goal is to: *Illustrate statistical applications in the pharmaceutical industry; *Illustrate how the statistical applications can be carried out using S-PLUS; *Illustrate why S-PLUS is a useful software package for carrying out these applications; *Discuss the results and implications of a particular application; The target audience for this book is very broad, including: *Graduate students in biostatistics; *Statisticians who are involved in the industry as research scientists, regulators, academics, and/or consultants who want to know more about how to use S-PLUS and learn about other sub-fields within the indsutry that they may not be familiar with; *Statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.

Is Industry-University Interaction Promoting Innovation in the Brazilian Pharmaceutical Industry?

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Paranhos, Julia; Hasenclever, Lia

2011-01-01

This paper analyses industry-university interaction and its characteristics in the Brazilian pharmaceutical system of innovation, taking account of the relevance of company strategies, the approach of the universities and the actions of government. By analysing primary and secondary data the authors show that, for as long as corporate investment…

Reconsidering Japan's underperformance in pharmaceuticals: evidence from Japan's anticancer drug sector.

Science.gov (United States)

Umemura, Maki

2010-01-01

Unlike its automobile or electronics industries, Japan's pharmaceutical industry did not become a global leader. Japan remains a net importer of pharmaceuticals and has introduced few global blockbuster drugs. Alfred Chandler argued that Japan's pharmaceutical firms remained relatively weak because Western firms enjoyed an insurmountable first first-mover advantage. However, this case study of the anticancer drug sector illustrates that Chandler's explanation is incomplete. Japanese medical culture, government policy, and research environment also played a substantial role in shaping the industry. In the 1970s and 1980s, these factors encouraged firms to develop little few effective drugs with low side effects, and profit from Japan's domestic market. But, these drugs were unsuitable to foreign markets with more demanding efficacy standards. As a result, Japan not only lost more than a decade in developing ineffective drugs, but also neglected to create the infrastructure necessary to develop innovative drugs and build a stronger pharmaceutical industry.

ASTM and ASME-BPE Standards--Complying with the Needs of the Pharmaceutical Industry.

Science.gov (United States)

Huitt, William M

2011-01-01

Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting nonpharmaceutical-related codes and standards and then modifying them in order to meet the more stringent requirements of the Food and Drug Administration (FDA). In 1997 the American Society of Mechanical Engineers (ASME) published the first Bioprocessing Equipment (BPE) Standard. Through harmonization efforts this relatively new standard has brought together, scrutinized, and refined industry accepted methodologies together with FDA compliance requirements, and has established an American National Standard that provides a comprehensive set of standards that are integral to the pharmaceutical industry. This article describes various American National Standards, including those developed and published by the American Society for Testing and Materials (ASTM), and how they apply to the pharmaceutical industry. It goes on to discuss the harmonization effort that takes place between the various standards developers in an attempt to prevent conflicts and omissions between the many standards. Also included are examples of tables and figures taken from the ASME-BPE Standard. These examples provide the reader with insight to the relevant content of the ASME-BPE Standard. Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting nonpharmaceutical-related codes and

What residents don't know about physician-pharmaceutical industry interactions.

Science.gov (United States)

Watkins, Raquel S; Kimberly, James

2004-05-01

Little is known about the knowledge and skills internal medicine residents need to interact appropriately with pharmaceutical industry representatives. The authors conducted a needs assessment of current knowledge and preferences for potential components of a new educational initiative among residents. In 2001, a two-page questionnaire using a five-point ordinal scale was mailed to all internal medicine residents and faculty at one institution. Analysis included use of Wilcoxon two-sample test. Response rates were 97% (85/88) for residents and 79% (86/109) for faculty. Residents and faculty's knowledge about formal position statements or literature on the impact of marketing strategies on prescribing patterns, drug marketing costs, or how pharmaceutical representatives are trained to interact with physicians was very limited. Most responders felt residents should learn to critically interpret promotional materials, recognize potential for conflict of interest, and consider how patients perceive the physician-pharmaceutical industry relationship. More faculty than residents valued including position statements (66% versus 39%, p marketing on prescribing patterns (70% versus 41%, p education. Only one-half or fewer favored small-group discussions, lecture series, critical-reading skills seminars, or panel discussions. Internal medicine residents and faculty reported low levels of knowledge about physician-pharmaceutical industry relationships. Some consensus about educational components existed, but optimal educational formats remain uncertain. A six-hour curriculum to address this complex, emotionally charged topic was developed, implemented, and evaluated.

Radiation protection in the pharmaceutical-chemical industry

International Nuclear Information System (INIS)

Griesser, R.

1992-01-01

Some aspects of the use of ionizing radiation in research in the pharmaceutical and chemical industries will be discussed, the emphasis being placed on the handling of open radioactive materials in research laboratories. The compliance with official regulations and the preparation of company internal radiation protection regulations are described. 1 tab., 9 refs

A survey of the effects of brand value on customer satisfaction in pharmaceutical and biological industries

OpenAIRE

Alipour, A.; Feizi, S.J.; Heidari, M.

2016-01-01

. The purpose of this study was to describe how companies in pharmaceutical and biological sectors can ensure their position in different markets by relying on sustainable, competitive advantages, resulting from the use of a well-defined marketing model with particular emphasis on brand improvement. As competition becomes more intense among companies and phenomena such as global marketing grow in importance, domestic industries in each country become obliged to improve their competitive advan...

The effects of advertising on sales in the pharmaceutical industry in ...

African Journals Online (AJOL)

Although advertising accounts for a major share of promotional expenditure of most companies in the pharmaceutical industry, most of them manifest considerable ignorance about how advertising works. This study aimed at determining the effect of advertising on the sales of pharmaceutical products bearing in mind the ...

Balancing health and industrial policy objectives in the pharmaceutical sector: lessons from Australia.

Science.gov (United States)

Morgan, Steve; McMahon, Meghan; Greyson, Devon

2008-08-01

Policy-makers worldwide struggle to balance health with industrial policy objectives in the pharmaceutical sector. Tensions arise over pricing and reimbursement in particular. What health plans view as necessary to maintain equitable access to medicines, industry views as inimical to R&D and innovation. Australia has grappled with this issue for years, even incorporating the goal of "maintaining a responsible and viable medicines industry" into its National Medicines Policy. This case study was conducted via a narrative review that examined Australia's experiences balancing health and industrial policy objectives in the pharmaceutical sector. The review included electronic databases, grey literature and government publications for reports on relevant Australian policy published over the period 1985-2007. While pharmaceutical companies claim that Australia's pricing and reimbursement policies suppress drug prices and reduce profits, national policy audits indicate these claims are misguided. Australia appears to have secured relatively low prices for generics and "me-too drugs" while paying internationally competitive prices for "breakthrough" medicines. Simultaneously, Australia has focused efforts on local pharmaceutical investment through a variety of industry-targeted R&D incentive policies. Despite the fact that policy reviews suggest that Australia has achieved balance between health and industrial policy objectives, the country continues to face criticism from industry that its health goals harm innovation and R&D. Recent reforms raise the question whether Australia can sustain the apparent balance.

The use of atomic spectroscopy in the pharmaceutical industry for the determination of trace elements in pharmaceuticals.

Science.gov (United States)

Lewen, Nancy

2011-06-25

The subject of the analysis of various elements, including metals and metalloids, in the pharmaceutical industry has seen increasing importance in the last 10-15 years, as modern analytical instrumentation has afforded analysts with the opportunity to provide element-specific, accurate and meaningful information related to pharmaceutical products. Armed with toxicological data, compendial and regulatory agencies have revisited traditional approaches to the testing of pharmaceuticals for metals and metalloids, and analysts have begun to employ the techniques of atomic spectroscopy, such as flame- and graphite furnace atomic absorption spectroscopy (FAAS, Flame AA or FAA and GFAAS), inductively coupled plasma-atomic emission spectroscopy (ICP-AES) and inductively coupled plasma-mass spectrometry (ICP-MS), to meet their analytical needs. Newer techniques, such as laser-induced breakdown spectroscopy (LIBS) and Laser Ablation ICP-MS (LAICP-MS) are also beginning to see wider applications in the analysis of elements in the pharmaceutical industry.This article will provide a perspective regarding the various applications of atomic spectroscopy in the analysis of metals and metalloids in drug products, active pharmaceutical ingredients (API's), raw materials and intermediates. The application of atomic spectroscopy in the analysis of metals and metalloids in clinical samples, nutraceutical, metabolism and pharmacokinetic samples will not be addressed in this work. Copyright © 2010 Elsevier B.V. All rights reserved.

Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review.

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Kirsten E Austad

2011-05-01

Full Text Available The relationship between health professionals and the pharmaceutical industry has become a source of controversy. Physicians' attitudes towards the industry can form early in their careers, but little is known about this key stage of development.We performed a systematic review reported according to PRISMA guidelines to determine the frequency and nature of medical students' exposure to the drug industry, as well as students' attitudes concerning pharmaceutical policy issues. We searched MEDLINE, EMBASE, Web of Science, and ERIC from the earliest available dates through May 2010, as well as bibliographies of selected studies. We sought original studies that reported quantitative or qualitative data about medical students' exposure to pharmaceutical marketing, their attitudes about marketing practices, relationships with industry, and related pharmaceutical policy issues. Studies were separated, where possible, into those that addressed preclinical versus clinical training, and were quality rated using a standard methodology. Thirty-two studies met inclusion criteria. We found that 40%-100% of medical students reported interacting with the pharmaceutical industry. A substantial proportion of students (13%-69% were reported as believing that gifts from industry influence prescribing. Eight studies reported a correlation between frequency of contact and favorable attitudes toward industry interactions. Students were more approving of gifts to physicians or medical students than to government officials. Certain attitudes appeared to change during medical school, though a time trend was not performed; for example, clinical students (53%-71% were more likely than preclinical students (29%-62% to report that promotional information helps educate about new drugs.Undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive attitudes about marketing and skepticism

Comparative analysis of pharmaceuticals versus industrial chemicals acute aquatic toxicity classification according to the United Nations classification system for chemicals. Assessment of the (Q)SAR predictability of pharmaceuticals acute aquatic toxicity and their predominant acute toxic mode-of-action.

Science.gov (United States)

Sanderson, Hans; Thomsen, Marianne

2009-06-01

Pharmaceuticals have been reported to be ubiquitously present in surface waters prompting concerns of effects of these bioactive substances. Meanwhile, there is a general scarcity of publicly available ecotoxicological data concerning pharmaceuticals. The aim of this paper was to compile a comprehensive database based on OECD's standardized measured ecotoxicological data and to evaluate if there is generally cause of greater concern with regards to pharmaceutical aquatic toxicological profiles relative to industrial chemicals. Comparisons were based upon aquatic ecotoxicity classification under the United Nations Global Harmonized System for classification and labeling of chemicals (GHS). Moreover, we statistically explored whether the predominant mode-of-action (MOA) for pharmaceuticals is narcosis. We found 275 pharmaceuticals with 569 acute aquatic effect data; 23 pharmaceuticals had chronic data. Pharmaceuticals were found to be more frequent than industrial chemicals in GHS category III. Acute toxicity was predictable (>92%) using a generic (Q)SAR ((Quantitative) Structure Activity Relationship) suggesting a narcotic MOA. Analysis of model prediction error suggests that 68% of the pharmaceuticals have a non-specific MOA. Additionally, the acute-to-chronic ratio (ACR) for 70% of the analyzed pharmaceuticals was below 25 further suggesting a non-specific MOA. Sub-lethal receptor-mediated effects may however have a more specific MOA.

Ties that bind: multiple relationships between clinical researchers and the pharmaceutical industry.

Science.gov (United States)

Henry, David; Doran, Evan; Kerridge, Ian; Hill, Suzanne; McNeill, Paul M; Day, Richard

2005-11-28

It is believed that pharmaceutical industry sponsorship of clinical research leads to the development of multiple ties between clinicians and the pharmaceutical industry. To quantify this relationship we conducted a survey of medical specialists listed in the Medical Directory of Australia in 2002 and 2003. A questionnaire was mailed that elicited information about all aspects of research relationships between clinicians and pharmaceutical companies. The odds of reporting multiple additional ties (financial and professional) with pharmaceutical companies by clinicians who had an active research relationship were compared with those who did not. All clinicians who returned a completed questionnaire about their research activities were included in the study. A questionnaire was mailed to 2120 medical specialists; 823 (39%) responded. Of these, 338 (41%) reported involvement in industry-sponsored research in the previous year. They were more likely than others to have been offered industry-sponsored items or activities valued at more than 500 AU dollars (>382 US dollars; odds ratio [OR], 3.5; 95% confidence interval [CI], 2.6-4.7) and support for attending international conferences (OR, 5.4; 95% CI, 3.9-7.4). The strongest associations were seen for acting as a paid consultant to industry (OR, 9.0; 95% CI, 3.9-20.4) and for membership on advisory boards (OR, 6.9; 95% CI, 5.1-9.6). There was a strong relationship between research collaboration and accumulation of industry ties. For 1 additional tie the OR was 2.2 (95% CI, 1.2-3.8) and rose to 6.3 (95% CI, 3.5-11.1) with 3 ties and 41.8 (95% CI, 14.5-143.4) with 6 or more ties. Medical specialists who have research relationships with the pharmaceutical industry are much more likely to have multiple additional ties than those who do not have research relationships. Institutional review should discourage clinical researchers from developing multiple ties.

Bioremediation Kinetics of Pharmaceutical Industrial Effluent

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M. Šabić

2015-05-01

Full Text Available In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmented activated sludge with isolated mixed bacterial culture. The experiments were conducted in a batch reactor in submerged conditions, at initial concentration of organic matter in pharmaceutical wastewater, expressed as COD, 5.01 g dm–3 and different initial concentrations of activated sludge, which ranged from 1.16 to 3.54 g dm–3. During the experiments, the COD, pH, concentrations of dissolved oxygen and biomass were monitored. Microscopic analyses were performed to monitor the quality of activated sludge. Before starting with the bioremediation in the batch reactor, toxicity of the pharmaceutical wastewater was determined by toxicity test using bacteria Vibrio fischeri. The obtained results showed that the effective concentration of the pharmaceutical wastewater was EC50 = 17 % and toxicity impact index was TII50 = 5.9, meaning that the untreated pharmaceutical industrial effluent must not be discharged into the environment before treatment. The results of the pharmaceutical wastewater bioremediation process in the batch reactor are presented in Table 1. The ratio γXv ⁄ γX maintained high values throughout all experiments and ranged from 0.90 and 0.95, suggesting that the concentrations of biomass remained unchanged during the experiments. The important kinetic parameters required for performance of the biological removal process, namely μmax, Ks, Ki, Y and kd were calculated from batch experiments (Table 2. Figs. 1 and 2 show the experimental

Looking at CER from the pharmaceutical industry perspective.

Science.gov (United States)

Dubois, Robert W

2012-05-01

Comparative effectiveness research (CER) is increasing as an element of health care reform in the United States. By comparing drugs against other drugs or other therapies instead of just to placebo, CER has the potential to improve decisions about the appropriate treatment for patients. But the growth of CER also brings an array of questions and decisions for purchasers and policy makers that will not be easy to answer and which require significant dialogue to fully understand and address. To describe some of the impact, both positive and negative, that comparative effectiveness research (CER) may have on the pharmaceutical industry. As CER data proliferate, questions are being raised about who can access the data, who can discuss it, and in what forums. Regulations place different communication restrictions on the pharmaceutical industry than on other health care stakeholders, which creates a potential inequality. Another CER consideration will be the tendency to apply average results to individuals, even if not every individual experiences the average result. Policy makers should implement CER findings carefully with a goal toward accommodating flexibility. A final impact to consider is whether greater expectations for CER will have a negative or positive effect on incentives for drug innovation. In some cases, CER may increase development costs or decrease market size. In other cases, better targeting of trial populations could result in lower development costs. The rising expectations and growth in CER raise questions about information access, communication restrictions, flexible implementation policies, and incentives for innovation. Members of the pharmaceutical industry should be cognizant of the questions and should be participating in dialogues now to pave the way for future solutions.

Manufacturing capability as a technological development indicator in the pharmaceutical industry

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John Jairo Gallo Castro

2010-01-01

Full Text Available The pharmaceutical industrial has five subsectors: medicines, cosmetics, phytotherapeutics, cleaning products and medical devices. The medicine subsector consists of organisations producing, importing and selling these products. Most studies about this industry have been guided by economic interests without assessing technological aspects of production. This article was aimed at proposing a methodology for assessing and describing the medicine sector according to its technological development by using the manufacturing capability concept. The main information was taken from the Colombian Medicaments and Food Surveillance Institute’s (Instituto Nacional de Vigilancia de Medicamentos y Alimentos - INVIMA databases related to pharmaceutical plant production in Bogotá, including material transformation facilities. This study led to three characteristics being identified for defining the pharmaceutical industry’s manufacturing capability: that related to the pharmacological group to which active pharmaceutical ingredients belong, that linked to specifications regarding medicines’ sterility and that related to the technology required for manufacturing each pharmaceutical product. An analysis of these features has thus been presented and some technologies have been identified which have not been transferred or assimilated by the organisations being studied. It was found that manufacturing capability should be considered as being an indicator of the degree of technological development in these subsectors in Colombia.

Transformation in the pharmaceutical industry--a systematic review of the literature.

Science.gov (United States)

Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J; Mouzughi, Yusra

2013-01-01

The evolutionary development of pharmaceutical transformation was studied through systematic review of the literature. Fourteen triggers were identified that will affect the pharmaceutical business, regulatory science, and enabling technologies in future years. The relative importance ranking of the transformation triggers was computed based on their prevalence within the articles studied. The four main triggers with the strongest literature evidence were Fully Integrated Pharma Network, Personalized Medicine, Translational Research, and Pervasive Computing. The theoretical quality risks for each of the four main transformation triggers are examined, and the remaining ten triggers are described. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities (this is termed pharmaceutical transformation). The impact of these changes on the approaches to quality risk management requires more understanding. In this paper, a comprehensive review of the academic, regulatory, and industry literature were used to identify 14 triggers that influence pharmaceutical transformation. The four main triggers, namely Fully Integrated Pharma Network, Personalized Medicine, Translational Research, and Pervasive Computing, were selected as the most important based on the strength of the evidence found during the literature review activity described in this paper. Theoretical quality risks for each of the four main transformation triggers are examined, and the remaining ten triggers are described.

Transformational and Transactional Leadership Impact on Organizational Performance in Pharmaceutical Industry in Yemen

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مراد محمد النشمي

2017-12-01

Full Text Available This study aimed at revealing the impact on transformational and transactional leadership in organizational performance of Pharmaceutical Industry in Yemen. The researchers have used descriptive analytical methods to answer the study questions and test the hypotheses. Questionnaire has been used for collecting quantitative data from the study sample which is a number of 227 middle and executive management in pharmaceutical companies. The study findings show that there is significant effect of all the dimensions of transformational and transactional leadership on organizational performance. Based on the regression analysis applied in the study, results indicated that transformational leadership is of the highest influencing variables on organizational performance. The study concluded that pharmaceutical companies adoption of modern leadership styles leads to distinguished performance. Keywords: Transformational leadership, Transactional leadership, Organizational performance, Pharmaceutical Industry.

Pre-Clinical Medical Students' Exposure to and Attitudes Toward Pharmaceutical Industry Marketing.

Science.gov (United States)

Fein, Eric H; Vermillion, Michelle L; Uijtdehaage, Sebastian H J

2007-12-01

Background - Recent studies have examined the exposures and attitudes of physicians and third- and fourth-year medical students toward pharmaceutical industry marketing, but fewer studies have addressed these topics among pre-clinical medical students. Thus, the purpose of this study was to assess pre-clinical students' level of exposure to the pharmaceutical industry and their attitudes toward marketing. Method - First and second-year medical students at UCLA completed a 40-item survey based on previous studies. Results - Over three quarters of pre-clinical students (78.5% or 226 of 288) responded to the survey. Exposure to pharmaceutical industry marketing started very early in medical school. Most second-year students (77%) had received gifts including drug samples after three semesters. Most felt that this would not affect their future prescribing behavior. Conclusions - These findings and findings from related studies, coupled with the students' desire to learn more about the issue, suggest that an early educational intervention addressing this topic may be warranted in American medical schools.

A lesson from Japan: research and development efficiency is a key element of pharmaceutical industry consolidation process.

Science.gov (United States)

Shimura, Hirohisa; Masuda, Sachiko; Kimura, Hiromichi

2014-02-01

Scholarly attention to pharmaceutical companies' ability to sustain research and development (R&D) productivity has increased as they increasingly handle business challenges. Furthermore, the deterioration of R&D productivity has long been considered a major cause of mergers and acquisitions (M&As). This study attempts to investigate quantitatively the possible causes of the deterioration and the relationship between the deterioration and M&As by examining the Japanese pharmaceutical industry. Japan from 1980 to 1997 is an ideal case because of the availability of official data, but more importantly the significant changes in its business environment at the time. Using the Malmquist Index and data envelopment analysis, we measured the deterioration of R&D productivity from 1980 to 1997 based on a sample of 15 Japanese companies. Two lessons can be learned from Japan's case. First, to sustain R&D productivity over the long term, companies should use licensing activities and focus on the dominant therapeutic franchises. Second, if a company fails significantly to catch up with the benchmark, it is likely to pursue an M&A or seek an alternative way to improve R&D productivity. These findings appear similar to the current situation of the global pharmaceutical industry, although Japan pursued more licensing activities than M&A to improve R&D productivity.

Public funding and private investment for R&D: a survey in China's pharmaceutical industry.

Science.gov (United States)

Qiu, Lan; Chen, Zi-Ya; Lu, Deng-Yu; Hu, Hao; Wang, Yi-Tao

2014-06-13

In recent years, China has experienced tremendous growth in its pharmaceutical industry. Both the Chinese government and private investors are motivated to invest into pharmaceutical research and development (R&D). However, studies regarding the different behaviors of public and private investment in pharmaceutical R&D are scarce. Therefore, this paper aims to investigate the current situation of public funding and private investment into Chinese pharmaceutical R&D. The primary data used in the research were obtained from the China High-tech Industry Statistics Yearbook (2002-2012) and China Statistical Yearbook of Science and Technology (2002-2012). We analyzed public funding and private investment in five aspects: total investment in the industry, funding sources of the whole industry, differences between provinces, difference in subsectors, and private equity/venture capital investment. The vast majority of R&D investment was from private sources. There is a significantly positive correlation between public funding and private investment in different provinces of China. However, public funding was likely to be invested into less developed provinces with abundant natural herbal resources. Compared with the chemical medicine subsector, traditional Chinese medicine and biopharmaceutical subsectors obtained more public funding. Further, the effect of the government was focused on private equity and venture capital investment although private fund is the mainstream of this type of investment. Public funding and private investment play different but complementary roles in pharmaceutical R&D in China. While being less than private investment, public funding shows its significance in R&D investment. With rapid growth of the industry, the pharmaceutical R&D investment in China is expected to increase steadily from both public and private sources.

The reality behind the pharmaceutical industry, postmodernity with no mercy

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Allan Rodríguez Artavia

2014-04-01

Full Text Available The following article analyzes the current need in the light of the principles of the (post modernity about the pharmaceutical industry. For its formulation, we conducted a literature review in the databases of the VirtualHealth Library (BIREME, and the Scientific Electronic Library Online (SciELO, where after applying predetermined inclusion criteria, it was possible to obtain a total of 23 items that served as the analysis base. Between the main results obtained in thirteen of the documents analyzed it criticizing the marketing process that has set as standard to follow in pharmaceutical production. In seven of the articles it is argued that by in pharmacological industry, there is limited access to medicines in countries or regions with less purchasing power, as there is reluctance to fund research related to diseases that are not profitable. It conclude that given currently own processes of neoliberal policies and capitalism that surround pharmaceutical production, lost focus on the health of the community, transforming such right in a process of marketing and commercialism.

Understanding firm, physician and consumer choice behavior in the pharmaceutical industry

NARCIS (Netherlands)

Manchanda, P; Wittink, DR; Ching, A; Cleanthous, P; Ding, M; Dong, XJJ; Leeflang, PSH; Misra, S; Mizik, N; Narayanan, S; Steenburgh, T; Wieringa, JE; Wosinska, M; Xie, Y

2005-01-01

This paper argues that the pharmaceutical industry represents an exciting opportunity to carry out academic research. The nature of the industry allows researchers to answer new questions, develop new methodologies for answering these questions as well as to apply existing methodology to new data.

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy.

Science.gov (United States)

Löfgren, Hans

2007-06-01

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products.

[Innovation guidelines and strategies for pharmaceutical engineering of Chinese medicine and their industrial translation].

Science.gov (United States)

Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li

2013-01-01

This paper briefly analyzes the bottlenecks and major technical requirements for pharmaceutical industry of Chinese medicine, providing current status of pharmaceutical engineering of Chinese medicine. The innovation directions and strategies of the pharmaceutical engineering for manufacturing Chinese medicine are proposed along with the framework of their core technology. As a consequence, the development of the third-generation pharmaceutical technology for Chinese medicine, featured as "precision, digital and intelligent", is recommended. The prospects of the pharmaceutical technology are also forecasted.

INNOVATIVE AND INDUSTRIAL-PERFORMANCE IN PHARMACEUTICAL RESEARCH-AND-DEVELOPMENT, A MANAGEMENT CONTROL PERSPECTIVE

NARCIS (Netherlands)

OMTA, SWF; BOUTER, LM; VANENGELEN, JML

In this paper management control is related to innovative and industrial performance in 14 non-biotech pharmaceutical companies. The study consisted of questionnaires, sent to the heads of the different research departments of European research laboratories of leading pharmaceutical companies,

Managing the pharmaceutical industry-health system interface.

Science.gov (United States)

Zarowitz, B J; Muma, B; Coggan, P; Davis, G; Barkley, G L

2001-12-01

Direct-to-consumer advertising, media, and Internet marketing to physicians and patients, as well as enticing marketing strategies, are used by the pharmaceutical industry to ensure market share growth of new drugs. Our health system adopted a strict vendor policy governing detailing and sampling activities of pharmaceutical representatives, but realized that further analysis of vendor influence in our system was needed. An assessment of tangible benefits, ethical concerns, and financial liabilities and gains was conducted to reassess the need for further vendor restriction. Based on our findings, several recommendations have been made. Medical practices and health systems are encouraged to establish and enforce explicit vendor policies, measure their effectiveness, partner proactively with representatives to deliver a drug-detailing message consistent with system initiatives, monitor and regulate continuing medical education funding, and implement strategies to ensure appropriate drug use.

Customer relationship management in the contract pharmaceutical industry: an exploratory study for measuring success.

Science.gov (United States)

Kros, John F; Nadler, Scott; Molis, Justin

2007-01-01

Managing customer relationships is a very important issue in business-to-business markets. This research investigates the growing number of available resources defining Customer Relationship Management (CRM) efforts, and how they are being applied within the Contract Pharmaceutical Manufacturing industry. Exploratory study results using face-to-face and telephone questionnaires based on four criteria for rating a company's CRM efforts are presented. Data was collected from large Contract Pharmaceutical Manufacturing companies in the US market. The results and conclusions are discussed relating how the Contract Pharmaceutical Manufacturing industry is implementing CRM including some potential steps to take when considering a CRM initiative.

How pharmaceutical industry employees manage competing commitments in the face of public criticism.

Science.gov (United States)

Lipworth, Wendy; Montgomery, Kathleen; Little, Miles

2013-10-01

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the "medical affairs" departments of pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance.

[AIDS and social justice: pharmaceutical industry and economics].

Science.gov (United States)

López Guzmán, José

2008-01-01

This article takes a broad look at the complicated framework of relationships between the third world and pharmaceutical companies. In the first part of the work reference is made to the poverty of these countries, their lack of education in terms of health, the scarcity of basic hygiene, and their greatly limited access to medicines, especially those for treating AIDS. The article then proceeds to the issue of the pharmaceutical companies' degree of responsibility for the reduced availability of medicines in certain areas of the world. One of the factors that most limits access to medicines is their price, and many sectors of society propose taking action on the patents of drugs (rescinding or limiting them) in order to lower their price. However, the problem of patent exemption is more complicated than it seems at first glance, and comes with its own risks. If, for lack of funds or the uncertainty concerning a return on the capital invested, pharmaceutical companies discontinue research and development of new drugs, AIDS therapy would worsen. It is imperative and urgent to develop new drugs against the AIDS because of its resistance to the drugs currently available. The article concludes with the pharmaceutical industry's effort to look for possible forms of collaboration with developing countries.

Total quality through computer integrated manufacturing in the pharmaceutical industry.

Science.gov (United States)

Ufret, C M

1995-01-01

The role of Computer Integrated Manufacturing (CIM) in the pursue of total quality in pharmaceutical manufacturing is assessed. CIM key objectives, design criteria, and performance measurements, in addition to its scope and implementation in a hierarchical structure, are explored in detail. Key elements for the success of each phase in a CIM project and a brief status of current CIM implementations in the pharmaceutical industry are presented. The role of World Class Manufacturing performance standards and other key issues to achieve full CIM benefits are also addressed.

Towards the design of a zero effluent facility in the pharmaceutical industry

CSIR Research Space (South Africa)

Gouws, JF

2007-05-01

Full Text Available . The pharmaceutical production industry has some unique characteristics that make it possible to reach the goal of zero effluent. In such industries wastewater is generally produced from washing out of mixing vessels. The wastewater thus contains valuable product...

The future of risk communication and the role of the pharmaceutical industry.

Science.gov (United States)

Chakraborty, Sweta; Bouder, Frederic

2013-02-01

Risk communication is an interactive two-way process that various stakeholders (e.g., patients, regulators, industry) utilize to address prescription drug safety. This paper will specifically examine the pharmaceutical industry's engagement with risk communication as a tool for information exchange with patients and other stakeholders about the associated risks related to its medicines. Risk communications are not solely meant to inform; and rather effective two-way risk communications have the potential to change behavioral outcomes for the purpose of individual and societal benefit. Despite this indispensable role of risk communication for the pharmaceutical industry, more research is needed for the appropriate development and dissemination of risk communications. A crucial missing component for the crafting of pharmaceutical risk communications is the understanding of risk perceptions from the patient/consumer's perspective. This is necessary to see where any divergences in views may lie between the industry and its final consumer, which is crucial in tailoring communications to target a specific erroneous belief or to address what might be deemed as a needed behavioral shift. It is also necessary to develop communications in consideration of the levels of public trust in the industry as well as other perceived actors in the healthcare system. Even the most meticulously crafted and tested risk communications will fail to fulfill their purpose if the role of trust is not taken into consideration. These considerations can lead to the establishment of a "social contract" that effectively addresses what is required from both parties for continued and mutually beneficial interactions. Conducting risk perception research, addressing the role of trust, establishing a social contract, and having a realistic outlook on the impact of risk communications are necessary considerations as pharmaceutical risk communication evolves for the future.

Public funding and private investment for R&D: a survey in China’s pharmaceutical industry

Science.gov (United States)

2014-01-01

Background In recent years, China has experienced tremendous growth in its pharmaceutical industry. Both the Chinese government and private investors are motivated to invest into pharmaceutical research and development (R&D). However, studies regarding the different behaviors of public and private investment in pharmaceutical R&D are scarce. Therefore, this paper aims to investigate the current situation of public funding and private investment into Chinese pharmaceutical R&D. Methods The primary data used in the research were obtained from the China High-tech Industry Statistics Yearbook (2002–2012) and China Statistical Yearbook of Science and Technology (2002–2012). We analyzed public funding and private investment in five aspects: total investment in the industry, funding sources of the whole industry, differences between provinces, difference in subsectors, and private equity/venture capital investment. Results The vast majority of R&D investment was from private sources. There is a significantly positive correlation between public funding and private investment in different provinces of China. However, public funding was likely to be invested into less developed provinces with abundant natural herbal resources. Compared with the chemical medicine subsector, traditional Chinese medicine and biopharmaceutical subsectors obtained more public funding. Further, the effect of the government was focused on private equity and venture capital investment although private fund is the mainstream of this type of investment. Conclusions Public funding and private investment play different but complementary roles in pharmaceutical R&D in China. While being less than private investment, public funding shows its significance in R&D investment. With rapid growth of the industry, the pharmaceutical R&D investment in China is expected to increase steadily from both public and private sources. PMID:24925505

Attitudes and relationship between physicians and the pharmaceutical industry in a public general hospital in Lima, Peru.

Directory of Open Access Journals (Sweden)

Aldo De Ferrari

Full Text Available BACKGROUND: The interaction between physicians and the pharmaceutical industry influences physicians' attitudes and prescribing behavior. Although largely studied in the US, this topic has not been well studied in resource-poor settings, where a close relationship between physicians and industry still exists. OBJECTIVE: To describe physician interactions with and attitudes towards the pharmaceutical industry in a public general hospital in Lima, Peru. DESIGN: Descriptive, cross-sectional study through an anonymous, self-filled questionnaire distributed among faculty and trainee physicians of five different clinical departments working in a Peruvian public general hospital. A transcultural validation of an existing Spanish questionnaire was performed. Exposure to marketing activities, motivations to contact pharmaceutical representatives and attitudes towards industry were studied. Collected data was analyzed by degree of training, clinical department, gender and teaching status. Attitudes were measured on a four-point LIKERT scale. RESULTS: 155 physicians completed the survey, of which 148 were included in the study sample. 94.5% of attending physicians reported ongoing encounters with pharmaceutical representatives. The most common industry-related activities were receiving medical samples (91.2%, promotional material (87.8% and attending meetings in restaurants (81.8%. Respondents considered medical samples and continuing medical education the most ethically acceptable benefits. We found significant differences between attendings and residents, and teaching and non-teaching attendings. An association between the amount of encounters with pharmaceutical representatives, and attitudes towards industry and acceptance of medical samples was found. CONCLUSIONS: A close physician-industry relationship exists in the population under study. The contact is established mainly through pharmaceutical representatives. Medical samples are the most received

The uncertainty budget in pharmaceutical industry

DEFF Research Database (Denmark)

Heydorn, Kaj

of their uncertainty, exactly as described in GUM [2]. Pharmaceutical industry has therefore over the last 5 years shown increasing interest in accreditation according to ISO 17025 [3], and today uncertainty budgets are being developed for all so-called critical measurements. The uncertainty of results obtained...... that the uncertainty of a particular result is independent of the method used for its estimation. Several examples of uncertainty budgets for critical parameters based on the bottom-up procedure will be discussed, and it will be shown how the top-down method is used as a means of verifying uncertainty budgets, based...

Building legitimacy by criticising the pharmaceutical industry: a qualitative study among prescribers and local opinion leaders.

Science.gov (United States)

Pittet, Anne-Laure; Saraga, Michael; Stiefel, Friedrich

2015-01-01

The literature has described opinion leaders not only as marketing tools of the pharmaceutical industry, but also as educators promoting good clinical practice. This qualitative study addresses the distinction between the opinion-leader-as-marketing-tool and the opinion-leader-as-educator, as it is revealed in the discourses of physicians and experts, focusing on the prescription of antidepressants. We explore the relational dynamic between physicians, opinion leaders and the pharmaceutical industry in an area of French-speaking Switzerland. Qualitative content analysis of 24 semistructured interviews with physicians and local experts in psychopharmacology, complemented by direct observation of educational events led by the experts, which were all sponsored by various pharmaceutical companies. Both physicians and experts were critical of the pharmaceutical industry and its use of opinion leaders. Local experts, in contrast, were perceived by the physicians as critical of the industry and, therefore, as a legitimate source of information. Local experts did not consider themselves opinion leaders and argued that they remained intellectually independent from the industry. Field observations confirmed that local experts criticised the industry at continuing medical education events. Local experts were vocal critics of the industry, which nevertheless sponsor their continuing education. This critical attitude enhanced their credibility in the eyes of the prescribing physicians. We discuss how the experts, despite their critical attitude, might still be beneficial to the industry's interests.

Factors That Attract Foreign Pharmaceutical Companies Setting Up R&D Center In Malaysia

OpenAIRE

Hee, Kenneth Kang Koon

2003-01-01

The development of the biotechnology and pharmaceutical industry is far reaching and their broad applications and great impacts have attracted global interest to enter these industries. Pharmaceutical R&D is a costly and risky business, but in recent years the financial rewards from R&D have more than offset its cost and risk. In order to ensure the continuous growth of Malaysia’s economy, the Malaysia government is actively developing these industries to be their star industry in 21st centur...

Polish physicians' cooperation with the pharmaceutical industry and its potential impact on public health.

Directory of Open Access Journals (Sweden)

Marta Makowska

Full Text Available This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health.It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians' website (Medycyna Praktyczna between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland.The majority of respondents (96.8% said that they had talked with pharmaceutical sales representatives (PSRs in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3% said they trusted the information provided by PSRs. Over one third of respondents (36.4% claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law.The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency and strengthen the ethical

Polish physicians' cooperation with the pharmaceutical industry and its potential impact on public health.

Science.gov (United States)

Makowska, Marta

2017-01-01

This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health. It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians' website (Medycyna Praktyczna) between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland. The majority of respondents (96.8%) said that they had talked with pharmaceutical sales representatives (PSRs) in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3%) said they trusted the information provided by PSRs. Over one third of respondents (36.4%) claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law. The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency and strengthen the ethical guidelines

Polish physicians’ cooperation with the pharmaceutical industry and its potential impact on public health

Science.gov (United States)

2017-01-01

Objective This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health. Methods It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians’ website (Medycyna Praktyczna) between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland. Results The majority of respondents (96.8%) said that they had talked with pharmaceutical sales representatives (PSRs) in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3%) said they trusted the information provided by PSRs. Over one third of respondents (36.4%) claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law. Conclusions The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency

Negative environmental impacts of antibiotic-contaminated effluents from pharmaceutical industries.

Science.gov (United States)

Bielen, Ana; Šimatović, Ana; Kosić-Vukšić, Josipa; Senta, Ivan; Ahel, Marijan; Babić, Sanja; Jurina, Tamara; González Plaza, Juan José; Milaković, Milena; Udiković-Kolić, Nikolina

2017-12-01

Effluents from pharmaceutical industries are recognized as significant contributors to aquatic pollution with antibiotics. Although such pollution has been mostly reported in Asia, knowledge on industrial discharges in other regions of the world, including Europe, and on the effects associated with such exposures is still limited. Thus, we performed chemical, microbiological and ecotoxicological analyses of effluents from two Croatian pharmaceutical industries during four seasons. In treated effluents of the company synthesizing macrolide antibiotic azithromycin (AZI), the total concentration of AZI and two macrolide by-products from its synthesis was 1-3 orders of magnitude higher in winter and springtime (up to 10.5 mg/L) than during the other two seasons (up to 638 μg/L). Accordingly, the highest total concentrations (up to 30 μg/L) in the recipient river were measured in winter and spring. Effluents from second company formulating veterinary antibiotics contained fluoroquinolones, trimethoprim, sulfonamides and tetracyclines ranging from low μg/L to approx. 200 μg/L. Low concentrations of these antibiotics, from below the limit of quantification to approx. few μg/L, have also been measured in the recipient stream. High frequency of culturable bacteria resistant to AZI (up to 83%) or sulfamethazine (up to 90%) and oxytetracycline (up to 50%) were also found in studied effluents. Finally, we demonstrated that toxicity to algae and water fleas often exceeded the permitted values. Most highly contaminated effluents induced multiple abnormalities in zebrafish embryos. In conclusion, using a wide array of analyses we have demonstrated that discharges from pharmaceutical industries can pose a significant ecological and public health concern due to their toxicity to aquatic organisms and risks for promoting development and spread of antibiotic resistance. Copyright © 2017 Elsevier Ltd. All rights reserved.

Pharmaceutical strategy and innovation: an academics perspective.

Science.gov (United States)

Baxendale, Ian R; Hayward, John J; Ley, Steven V; Tranmer, Geoffrey K

2007-06-01

The pharmaceutical industry is under increasing pressure on many fronts, from investors requiring larger returns to consumer groups and health authorities demanding cheaper and safer drugs. It is also feeling additional pressure from the infringement upon its profit margins by generic drug producers. Many companies are aggressively pursuing outsourcing contracts in an attempt to counter many of the financial pressures and streamline their operations. At the same time, the productivity of the pharmaceutical industry at its science base is being questioned in terms of the number of products and the timeframes required for each company to deliver them to market. This has generated uncertainties regarding the current corporate strategies that have been adopted and the levels of innovation being demonstrated. In this essay we discuss these topics in the context of the global pharmaceutical market, investigating the basis for many of these issues and highlighting the hurdles the industry needs to overcome, especially as they relate to the chemical sciences.

Discovery of innovative therapeutics: today's realities and tomorrow's vision. 1. Criticisms faced by the pharmaceutical industry.

Science.gov (United States)

Abou-Gharbia, Magid; Childers, Wayne E

2013-07-25

The pharmaceutical industry is facing enormous challenges, including reduced efficiency, declining innovation, key patent expirations, fierce price competition from generics, high regulatory hurdles, and a tarnished image. There is a clear need for change in the paradigms designed to address these challenges. Pharma has responded by embarking on a range of initiatives. However, along the way the industry has accrued critics whose accusations have tainted its reputation. The first part of this two-part series will discuss the criticisms that have been leveled at the pharmaceutical industry and summarize the supporting data for and against these criticisms. The second installment will focus on the current challenges facing the pharmaceutical industry and Pharma's responses to address these challenges. It will describe the industry's changing perspective and new business models for coping with the recent loss of talent and declining clinical pipelines as well as present some examples of recent drug discovery successes.

Biotechnological applications of functional metagenomics in the food and pharmaceutical industries.

Science.gov (United States)

Coughlan, Laura M; Cotter, Paul D; Hill, Colin; Alvarez-Ordóñez, Avelino

2015-01-01

Microorganisms are found throughout nature, thriving in a vast range of environmental conditions. The majority of them are unculturable or difficult to culture by traditional methods. Metagenomics enables the study of all microorganisms, regardless of whether they can be cultured or not, through the analysis of genomic data obtained directly from an environmental sample, providing knowledge of the species present, and allowing the extraction of information regarding the functionality of microbial communities in their natural habitat. Function-based screenings, following the cloning and expression of metagenomic DNA in a heterologous host, can be applied to the discovery of novel proteins of industrial interest encoded by the genes of previously inaccessible microorganisms. Functional metagenomics has considerable potential in the food and pharmaceutical industries, where it can, for instance, aid (i) the identification of enzymes with desirable technological properties, capable of catalyzing novel reactions or replacing existing chemically synthesized catalysts which may be difficult or expensive to produce, and able to work under a wide range of environmental conditions encountered in food and pharmaceutical processing cycles including extreme conditions of temperature, pH, osmolarity, etc; (ii) the discovery of novel bioactives including antimicrobials active against microorganisms of concern both in food and medical settings; (iii) the investigation of industrial and societal issues such as antibiotic resistance development. This review article summarizes the state-of-the-art functional metagenomic methods available and discusses the potential of functional metagenomic approaches to mine as yet unexplored environments to discover novel genes with biotechnological application in the food and pharmaceutical industries.

Biotechnological applications of functional metagenomics in the food and pharmaceutical industries

Directory of Open Access Journals (Sweden)

Laura M Coughlan

2015-06-01

Full Text Available Microorganisms are found throughout nature, thriving in a vast range of environmental conditions. The majority of them are unculturable or difficult to culture by traditional methods. Metagenomics enables the study of all microorganisms, regardless of whether they can be cultured or not, through the analysis of genomic data obtained directly from an environmental sample, providing knowledge of the species present and allowing the extraction of information regarding the functionality of microbial communities in their natural habitat. Function-based screenings, following the cloning and expression of metagenomic DNA in a heterologous host, can be applied to the discovery of novel proteins of industrial interest encoded by the genes of previously inaccessible microorganisms. Functional metagenomics has considerable potential in the food and pharmaceutical industries, where it can, for instance, aid (i the identification of enzymes with desirable technological properties, capable of catalysing novel reactions or replacing existing chemically synthesized catalysts which may be difficult or expensive to produce, and able to work under a wide range of environmental conditions encountered in food and pharmaceutical processing cycles including extreme conditions of temperature, pH, osmolarity, etc; (ii the discovery of novel bioactives including antimicrobials active against microorganisms of concern both in food and medical settings; (iii the investigation of industrial and societal issues such as antibiotic resistance development. This review article summarizes the state-of-the-art functional metagenomic methods available and discusses the potential of functional metagenomic approaches to mine as yet unexplored environments to discover novel genes with biotechnological application in the food and pharmaceutical industries.

Pharmaceutical technology management--profitable business avenue.

Science.gov (United States)

Puthli, Shivanand P

2010-01-01

Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.

Pharmaceutical policies in European countries.

Science.gov (United States)

Barros, Pedro Pita

2010-01-01

Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

Importance of marketing management in the world pfarmaceutical industry

OpenAIRE

Dragan Kesič; Andrej Bertoncelj

2008-01-01

The world pharmaceutical industry has changed tremendously in the last decade. Globalization processes reinforce a consolidation of the world pharmaceutical industry. Mergers and acquisitions prevail more and more as a strategic orientation of numerous world pharmaceutical companies. In our research we found out that marketing management has been playing an increasingly important or even a crucial role in day-today activities and strategic business operations of the world pharmaceutical compa...

Structural-functional and parametric analysis of the social function of pharmaceutical industry

Directory of Open Access Journals (Sweden)

N. O. Tkachenko

2016-12-01

Full Text Available Pharmacy has always had a special (social value and was sensitive to the new social changes in the society and the state. These changes allow better understand the issues associated with increasing the efficiency of pharmaceutical care to the population. The aim of the work: identify, justify and to summarize the main elements of the social function of pharmacy, as a component of health care system, to further evaluate the properties of the pharmaceutical industry as a system. Materials and methods. To achieve this goal the principle of a systematic approach and the complex of research methods such as structural, functional and parametric analysis, logical knowledge and comparison, ad also generalization have been used. As materials of research, we used the results of fundamental and applied research of national and foreign experts on the issue. Results and discussion. The basic principles of the welfare state and pharmacy as socially oriented sectors of the economy have been determined. We have found that the pharmaceutical industry is an agent, which implements a number of elements of the social function, such as pharmaceutical assistance to the population, the production of social goods (drugs, medical products, medical cosmetics, etc., creating and providing of working places, paying taxes (replenishment of the state budget, the formation and development of human capital, research and innovation activities, charity and sponsorship, environmental protection. Ukraine formally acceded to United Nations document, «Agenda for the XXI Century». This agreement commits our government to implement development and implementation of sustainable development strategies. Its main components are the social responsibility, social integration, an efficient worker and effective owner. Social responsibility acts as a reverse reaction on realization of social policy through the main sectors of the economy. Conclusions. We have summarized the information and

Monopolistic structures and industrial analysis in Spain: the case of the pharmaceutical industry.

Science.gov (United States)

Lobo, F

1979-01-01

This article seeks to illustrate the monopolistic structure of the Spanish pharmaceutical industry, focusing on its many dimensions. The basic conditions of technology and demand, product differentiation, effect of advertising, and barriers to entry are considered, as is financial and economic concentration. Although economic conditions are emphasized, the ways they affect public and private health, the quality of health services, and health education are also highlighted.

The Direct and Indirect Impact of Pharmaceutical Industry in Economic Expansion and Job Creation: Evidence from Bootstrapping and Normal Theory Methods

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Rizwan Raheem Ahmed

2018-05-01

Full Text Available The objective of this research article is to examine the role of Pakistan’s pharmaceutical industry in job creation opportunities, with the sacred intention to eradicate poverty, and expansion in economic activities. This research is quantitative in nature, and the data is directly gathered through closed-ended questionnaires from 300 respondents. Besides predictors’, four mediating variables have also been taken into consideration that contribute indirectly in job creation opportunities. Bootstrapping and Normal theory methods have been employed in order to examine the impact of predictors’ and mediating variables. The result of this research confirmed that pharmaceutical industry plays a vital role in job creation in Pakistan. It is further concluded that the pharmaceutical industry has a direct and significant impact in job creation by providing indigenous and direct job opportunities in sales, marketing, and other supporting departments for both skilled and unskilled workers. Pharmaceutical industry also provides indirect job opportunities through other industries, which are very much linked with this industry, such as: pharmaceutical distributors, dealers, retailers, wholesalers, hotel industry, and event management industry. It is also determined that pharmaceutical industry is acting like knowledge and skills imparting institutions. Therefore, skilled-based training and organizational learning are major mediating variables that transform unskilled people into human assets, which further trigger the future job prospects. Since pharmaceutical industry is one of the biggest industries in Pakistan, providing plenteous opportunities of new jobs with consistent growth. Thus, mediating variables such as motivation and interpersonal influence also preceded an active role in new job creation

Corporate social responsibility in global health: an exploratory study of multinational pharmaceutical firms.

Science.gov (United States)

Droppert, Hayley; Bennett, Sara

2015-04-09

As pharmaceutical firms experience increasing civil society pressure to act responsibly in a changing globalized world, many are expanding and/or reforming their corporate social responsibility (CSR) strategies. We sought to understand how multinational pharmaceutical companies currently engage in CSR activities in the developing world aimed at global health impact, their motivations for doing so and how their CSR strategies are evolving. We conducted a small-scale, exploratory study combining (i) an in-depth review of publicly available data on pharmaceutical firms' CSR with (ii) interviews of representatives from 6 firms, purposively selected, from the highest earning pharmaceutical firms worldwide. Corporate social responsibility differed for each firm particularly with respect to how CSR is defined, organizational structures for managing CSR, current CSR activities, and motivations for CSR. Across the firms studied, the common CSR activities were: differential pharmaceutical pricing, strengthening developing country drug distribution infrastructure, mHealth initiatives, and targeted research and development. Primary factors that motivated CSR engagement were: reputational benefits, recruitment and employee satisfaction, better rankings in sustainability indices, entrance into new markets, long-term economic returns, and improved population health. In terms of CSR strategy, firms were at different points on a spectrum ranging from philanthropic donations to integrated systemic shared value business models. CSR is of increasing importance for multinational pharmaceutical firms yet understanding of the array of CSR strategies employed and their effects is nascent. Our study points to the need to (i) develop clearer and more standardized definitions of CSR in global health (2) strengthen indices to track CSR strategies and their public health effects in developing countries and (iii) undertake more country level studies that investigate how CSR engages with

Why the MDGs need good governance in pharmaceutical systems to promote global health.

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Kohler, Jillian Clare; Mackey, Tim Ken; Ovtcharenko, Natalia

2014-01-21

Corruption in the health sector can hurt health outcomes. Improving good governance can in turn help prevent health-related corruption. We understand good governance as having the following characteristics: it is consensus-oriented, accountable, transparent, responsive, equitable and inclusive, effective and efficient, follows the rule of law, is participatory and should in theory be less vulnerable to corruption. By focusing on the pharmaceutical system, we explore some of the key lessons learned from existing initiatives in good governance. As the development community begins to identify post-2015 Millennium Development Goals targets, it is essential to evaluate programs in good governance in order to build on these results and establish sustainable strategies. This discussion on the pharmaceutical system illuminates why. Considering pharmaceutical governance initiatives such as those launched by the World Bank, World Health Organization, and the Global Fund, we argue that country ownership of good governance initiatives is essential but also any initiative must include the participation of impartial stakeholders. Understanding the political context of any initiative is also vital so that potential obstacles are identified and the design of any initiative is flexible enough to make adjustments in programming as needed. Finally, the inherent challenge which all initiatives face is adequately measuring outcomes from any effort. However in fairness, determining the precise relationship between good governance and health outcomes is rarely straightforward. Challenges identified in pharmaceutical governance initiatives manifest in different forms depending on the nature and structure of the initiative, but their regular occurrence and impact on population-based health demonstrates growing importance of addressing pharmaceutical governance as a key component of the post-2015 Millennium Development Goals. Specifically, these challenges need to be acknowledged and

Pharmaceutical industry's corporate social responsibility towards HIV/AIDS.

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Khanna, Arun Kumar

2006-01-01

The pharmaceutical industry has a corporate social responsibility (CSR) towards HIV/AIDS. Measures taken to increase awareness of HIV/AIDS, availability and accessibility of potent and patient-friendly FDCs / Kits for adults and children will go a long way in increasing awareness and acceptance of this disease and its therapy. This will improve adherence, lower resistance and facilitate better disease management. This article discusses some of the CSR initiatives and their scope.

Financial Aspects and the Future of the Pharmaceutical Industry in the United States of America

OpenAIRE

Karamehic, Jasenko; Ridic, Ognjen; Ridic, Goran; Jukic, Tomislav; Coric, Jozo; Subasic, Djemo; Panjeta, Mirsad; Saban, Aida; Zunic, Lejla; Masic, Izet

2013-01-01

Introduction: The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as “companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use”. Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers’ lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one ...

Pharmaceutical industry and trade liberalization using computable general equilibrium model.

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Barouni, M; Ghaderi, H; Banouei, Aa

2012-01-01

Computable general equilibrium models are known as a powerful instrument in economic analyses and widely have been used in order to evaluate trade liberalization effects. The purpose of this study was to provide the impacts of trade openness on pharmaceutical industry using CGE model. Using a computable general equilibrium model in this study, the effects of decrease in tariffs as a symbol of trade liberalization on key variables of Iranian pharmaceutical products were studied. Simulation was performed via two scenarios in this study. The first scenario was the effect of decrease in tariffs of pharmaceutical products as 10, 30, 50, and 100 on key drug variables, and the second was the effect of decrease in other sectors except pharmaceutical products on vital and economic variables of pharmaceutical products. The required data were obtained and the model parameters were calibrated according to the social accounting matrix of Iran in 2006. The results associated with simulation demonstrated that the first scenario has increased import, export, drug supply to markets and household consumption, while import, export, supply of product to market, and household consumption of pharmaceutical products would averagely decrease in the second scenario. Ultimately, society welfare would improve in all scenarios. We presents and synthesizes the CGE model which could be used to analyze trade liberalization policy issue in developing countries (like Iran), and thus provides information that policymakers can use to improve the pharmacy economics.

Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good

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Faunce Thomas

2006-03-01

Full Text Available Abstract • Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.

Homochiral drugs: a demanding tendency of the pharmaceutical industry.

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Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M

2009-01-01

The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision.

Respecting the right to access to medicines: Implications of the UN Guiding Principles on Business and Human Rights for the pharmaceutical industry.

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Moon, Suerie

2013-06-14

What are the human rights responsibilities of pharmaceutical companies with regard to access to medicines? The state-based international human rights framework has long struggled with the issue of the human rights obligations of non-state actors, a question sharpened by economic globalization and the concomitant growing power of private for-profit actors ("business"). In 2011, after a six-year development process, the UN Human Rights Council unanimously endorsed the Guiding Principles advanced by the UN Secretary General's Special Representative on Business and Human Rights, John Ruggie. The Ruggie Principles sought to clarify and differentiate the responsibilities of states and non-state actors-in this case, "business" -with respect to human rights. The framework centered on "three core principles: the state duty to protect against human rights abuses by third parties, including business; the corporate responsibility to respect human rights; and the need for more effective access to remedies." The "Protect, Respect, and Remedy" Framework emerged from a review of many industrial sectors operating from local to global scales, in many regions of the world, and involving multiple stakeholder consultations. However, their implications for the pharmaceutical industry regarding access to medicines remain unclear. This article analyzes the 2008 Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines advanced by then-UN Special Rapporteur on the Right to Health, Paul Hunt, in light of the Ruggie Principles. It concludes that some guidelines relate directly to the industry's responsibility to respect the right to access to medicines, and form a normative baseline to which firms should be held accountable. It also finds that responsibility for other guidelines may better be ascribed to states than to private actors, based on conceptual and practical considerations. While not discouraging the pharmaceutical industry from making additional

Pharmaceutical expenditure changes in Serbia and Greece during the global economic recession

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Mihajlo Jakovljevic

2016-04-01

Full Text Available Aim: Clarity on health expenditures is essential for the timely identification of risks that jeopardize the democratic provision of health services and the credibility of health insurance systems. Furthermore, observing health outcomes with geographical scope is essential for making multilateral associations. This study aimed at conveying information on the variability of important economic parameters of the health sector of Serbia and Greece from 2007 to 2012, when the most serious financial crisis in the post-war economic history hit the global economy. Methods: Exchange rates, purchase-power-parities (PPP and price indices were used for the bilateral review of health and pharmaceutical expenditure dynamics during 2007-2012. Prescription and dispensing changes were also studied taking into account the anatomical therapeutic chemical (ATC structure of drugs consumed. Results: Greece was forced to cut down its total health care and pharmaceutical expenditure and mainly its out-of-pocket payments were more seriously affected by the recession. Surprisingly, emerging market of Serbia, although severely damaged by global recession, succeeded to maintain 19% growth of its per capita health expenditure and even 25% increase of its per capita spending on pharmaceuticals. Innovative pharmaceuticals showed an upward trend in both countries. Conclusions: These two countries might serve as an example of two distinct pathways of mature and emerging health care markets during financial constraints caused by global recession. Our findings show that producing disease-based feedback, in the long run, may empower the assessment of the return on investment on medical technology and healthcare systems’ cost-effectiveness.

Medical students' exposure to pharmaceutical industry marketing: a survey at one U.S. medical school.

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Bellin, Melena; McCarthy, Susan; Drevlow, Laurel; Pierach, Claus

2004-11-01

While much is known about the interactions between the pharmaceutical industry and physicians, very little is known about pharmaceutical marketing directed toward medical students. This study sought to characterize the extent and forms of medical students' exposure to pharmaceutical industry marketing. In 2001-02, an anonymous, 17-item questionnaire was distributed to 165 preclinical and 116 clinical students at the University of Minnesota Medical School-Twin Cities. The main outcome measures were the number and forms of exposures to pharmaceutical industry marketing reported by medical students and whether students had discussed these exposures with teachers or advisors. Preclinical and clinical students were compared using chi(2) analysis (p marketing. Seventy-six (71.7%) clinical students compared to 38 (33.3%) preclinical students recalled over 20 exposures (p textbook (p marketing with an instructor or advisor; 59 (55.7%) clinical students as compared to 87 (80.6%) preclinical students recalled no such discussion (p marketing during their early years of training. Given existing evidence that such exposure influences physicians' practice and prescribing patterns, the authors propose that medical school curricula include formal instruction to prepare students to critically assess these contacts.

Microbial Tyrosinases: Promising Enzymes for Pharmaceutical, Food Bioprocessing, and Environmental Industry

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Kamal Uddin Zaidi

2014-01-01

Full Text Available Tyrosinase is a natural enzyme and is often purified to only a low degree and it is involved in a variety of functions which mainly catalyse the o-hydroxylation of monophenols into their corresponding o-diphenols and the oxidation of o-diphenols to o-quinones using molecular oxygen, which then polymerizes to form brown or black pigments. The synthesis of o-diphenols is a potentially valuable catalytic ability and thus tyrosinase has attracted a lot of attention with respect to industrial applications. In environmental technology it is used for the detoxification of phenol-containing wastewaters and contaminated soils, as biosensors for phenol monitoring, and for the production of L-DOPA in pharmaceutical industries, and is also used in cosmetic and food industries as important catalytic enzyme. Melanin pigment synthesized by tyrosinase has found applications for protection against radiation cation exchangers, drug carriers, antioxidants, antiviral agents, or immunogen. The recombinant V. spinosum tryosinase protein can be used to produce tailor-made melanin and other polyphenolic materials using various phenols and catechols as starting materials. This review compiles the recent data on biochemical and molecular properties of microbial tyrosinases, underlining their importance in the industrial use of these enzymes. After that, their most promising applications in pharmaceutical, food processing, and environmental fields are presented.

Spin-off and Innovation in the Pharmaceutical Industry

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Enzo Peruffo

2014-11-01

Full Text Available Parent companies usually undertake corporate spin-offs to cope with higher competitive environments or when, in high technology industries, the differences between R&D investments and intangible assets are larger. Consistent with the recent “positive view”, spinoffs can be considered as a “proactive strategic choice” to foster innovation, develop new activities, being different from past strategic initiatives and, more generally, not being strictly connected to the corporate strategy of the firm. In order to investigate the relation between divestiture decisions and innovation, we conduct an explorative case study in the pharmaceutical industry to show how spin-offs can help firms to explore new opportunities for innovation, search for new funding and push to create the basis for future development.

"Does organizational culture influence the ethical behavior in the pharmaceutical industry?".

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Nagashekhara, Molugulu; Agil, Syed Omar Syed

2011-12-01

Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured questionnaire. The research design is hypothesis testing. It is a cross-sectional and correlational study, conducted under non-contrived settings. Chi-square tests were shows that there is an association between the organizational culture and ethical behavior of medical representatives. In addition, the strength of the association is measured which report to Cramer's V of 63.1% and Phi Value of 2.749. Results indicate that multinational company medical reps are more ethical compared to domestic company medical representatives vast difference in both variance and in t test results. Through better organizational culture, pharmaceutical companies can create the most desirable behavior among their employees. Authors conclude that apart from organizational culture, the study of additional organizational, individual and external factors are imperative for better understanding of ethical behavior of medical representatives in the pharmaceutical industry in India.

[Research in the pharmaceutical industry cannot be objective].

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Becker-Brüser, Wolfgang

2010-01-01

In the face of tight public budgets more and more studies are being funded by the pharmaceutical industry. At the same time responsibility for conducting company-funded trials is increasingly being shifted to contract research organisations. Pharmaceutical manufacturers sponsor trials that primarily pursue company interests. The dominance of company-funded research does not only have a bearing on the choice of study priorities, though. Company sponsorship also has an influence on the results of trials. Company-funded trials are four times more likely to find evidence in favour of the trial drug than studies funded by other sponsors. There are several contributory factors, from study design (design bias) to data manipulation. And non-publication (publication bias) can distort knowledge. As a result, it is largely impossible to reliably assess the benefit and harm of medical drugs on the basis of published trials. This will have repercussions for the reliability of meta-analyses, guidelines and patient information leaflets. One consequence may be treatment errors.

Pattern of Duplicate Presentations at National Hematology-Oncology Meetings: Influence of the Pharmaceutical Industry.

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Ramchandren, Radhakrishnan; Schiffer, Charles A

2016-03-01

The major large US hematology-oncology meetings sponsored by the American Society of Hematology (ASH) and American Society of Clinical Oncology (ASCO) have specific guidelines in place discouraging submission of scientific information presented previously at other meetings. Nonetheless, duplicate submissions are frequent. The incidence and motivations for duplicate hematologic presentations and the influence of the pharmaceutical industry on this process have not been thoroughly analyzed. Therefore, were viewed four consecutive ASH and ASCO meetings to assess the frequency of duplicate abstract presentations. All abstracts presented at ASCO2010 in the area of malignant hematology were compared with abstracts from ASCO and ASH 2009 and ASH 2010, and funding sources were reviewed. More than half (54%) of all abstracts submitted to ASCO 2010 acknowledged pharmaceutical company support. Almost one third (31%) of ASCO 2010 abstracts were resubmitted in the 2-year time period, and it was notable that a high fraction (75%) of these duplicate abstracts had pharmaceutical industry sponsorship, compared with 42% of the abstracts that were submitted only once. Despite current guidelines prohibiting duplicate abstract presentation, a substantial proportion (31%) of abstracts at large international hematology-oncology meetings are duplicative, with potential negative consequences. In addition, a disproportionate percentage of the duplicate abstracts rely on pharmaceutical industry support (75%), suggesting that marketing strategies may be a motivation for some of these repetitive submissions.

Qualitative Phenomenological Examination of IT Project Management in Pharmaceutical Industry

Science.gov (United States)

Ly, Phil

2013-01-01

The purpose of this study was to examine what caused IT projects to fail at a high rate in the pharmaceutical industry. IT projects failures delayed development of new drugs that can help save lives. It was imperative to evaluate what caused project failures because the collateral damage was delay in drug development. This qualitative…

Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices

Science.gov (United States)

Raveis, Victoria H.; Friedman, Anne; Rothman, David J.

2011-01-01

Health advocacy organizations (HAOs) are influential stakeholders in health policy. Although their advocacy tends to closely correspond with the pharmaceutical industry's marketing aims, the financial relationships between HAOs and the pharmaceutical industry have rarely been analyzed. We used Eli Lilly and Company's grant registry to examine its grant-giving policies. We also examined HAO Web sites to determine their grant-disclosure patterns. Only 25% of HAOs that received Lilly grants acknowledged Lilly's contributions on their Web sites, and only 10% acknowledged Lilly as a grant event sponsor. No HAO disclosed the exact amount of a Lilly grant. As highly trusted organizations, HAOs should disclose all corporate grants, including the purpose and the amount. Absent this disclosure, legislators, regulators, and the public cannot evaluate possible conflicts of interest or biases in HAO advocacy. PMID:21233424

[Early achievements of the Danish pharmaceutical industry-7].

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Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

2014-01-01

A/S GEA Farmaceutisk Fabrik was established as a family business in 1927 by the pharmacist Knud L. Gad Andresen who until then had been employed in the pharmaceutical industry. Gad Andresen wanted to run a company focusing on the development of generics, and he wanted this development to take place in a close cooperation with Danish physicians. This has indeed been achieved with success. In 1995 GEA was purchase'd by the American pharmaceutical company Bristol-Myers Squibb who in a press release characterized GEA as Denmark's second largest manufacturer of generics. Immediately after this takeover GEA's R&D department ceased the research in innovative products and from now on exclusively focused on the development of generics. Three years later GEA was sold to the German generic company Hexal who later on resold GEA to the Swiss generic company Sandoz. GEA changed ownership another couple of times until the last owner went bankrupt in 2011. GEA is yet again a model example of an early Danish pharmaceutical company which was established as an individual company, and which had a long commercial success with the production and marketing of generics. GEA's earliest products, the organotherapeutics, were not innovations. The innovative products were developed already in the 1890s in Denmark by Alfred Benzon, and later on copies followed a.o. from Medicinalco and from foreign companies before GEA marketed their generics. Therefore GEA had to promote their preparations as especially qualified medicinal products and to intimate that the products of the competitors were less "active'". At the end of the 1920s the Ministry of Health became aware of the fact that there might be health problems related to the none-existing control of both the or- ganotherapeutic preparations and actually also the other medicinal products of the pharmaceutical industry. Therefore the Ministry had requested the National Board of Health for a statement regarding this problem. The National Board

Evaluation of cleaner production audit in pharmaceutical production industry: case study of the pharmaceutical plant in Dalian, P. R. China

Energy Technology Data Exchange (ETDEWEB)

Li, Zhi-dong [Dalian University of Technology, Key Laboratory of Industrial Ecology and Environmental Engineering (MOE), School of Environmental Science and Technology, Dalian (China); Dalian Cleaner Production Centre, Dalian, Liaoning (China); Dalian Municipal Design and Research Institute of Environmental Science, Dalian, Liaoning (China); Zhang, Shu-shen; Zhang, Yun [Dalian University of Technology, Key Laboratory of Industrial Ecology and Environmental Engineering (MOE), School of Environmental Science and Technology, Dalian (China); Zhang, Yong; Wei, Li [Dalian Cleaner Production Centre, Dalian, Liaoning (China); Dalian Municipal Design and Research Institute of Environmental Science, Dalian, Liaoning (China)

2011-02-15

The pharmaceutical industry in China makes an important contribution to the national economy. However, the associated pollution problems cause gradual deterioration of the environment and impact adversely on the local community. Cleaner production (CP) technology, an effective way to reduce waste emission and save resources, has been widely employed in the pharmaceutical industry in the developed countries. Such technologies have been applied in a number of factories in China, although there is no integrated assessment and implementation procedure for implementing CP technologies in pharmaceutical plants. To solve such problems, a series of CP options are proposed and assessed here. CP is a powerful tool for decreasing waste production, limiting environmental pollution and natural resource depletion. Moreover, the return on investment in CP is quick, so it would seem that CP activities should be very much in demand by enterprises. Reality is less optimistic: frequently only limited interest is expressed, even after an explanation; business people hesitate to become actively involved. The processes in the pharmaceutical production industry produce a vast amount of waste, including wastewater with high concentrations of organic substances (the principal component), solid waste, and organic off-gas. To solve such problems, a series of CP options are proposed and assessed in this study. Having consideration to environmental impacts and economic efficiency, four groups of medium/high cost CP options were screened in an integrated assessment. To verify the proposed options, a case study was conducted in Degussa Luyuan, Northeast China. The characteristics of resource consumption and waste emission during the production process were identified. The proposed options were evaluated according to different aspects. An integrated CP system based on the proposed options was designed and then implemented in the factory. In three years of practical use, the productivity and

Membrane-Based Technologies in the Pharmaceutical Industry and Continuous Production of Polymer-Coated Crystals/Particles.

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Chen, Dengyue; Sirkar, Kamalesh K; Jin, Chi; Singh, Dhananjay; Pfeffer, Robert

2017-01-01

Membrane technologies are of increasing importance in a variety of separation and purification applications involving liquid phases and gaseous mixtures. Although the most widely used applications at this time are in water treatment including desalination, there are many applications in chemical, food, healthcare, paper and petrochemical industries. This brief review is concerned with existing and emerging applications of various membrane technologies in the pharmaceutical and biopharmaceutical industry. The goal of this review article is to identify important membrane processes and techniques which are being used or proposed to be used in the pharmaceutical and biopharmaceutical operations. How novel membrane processes can be useful for delivery of crystalline/particulate drugs is also of interest. Membrane separation technologies are extensively used in downstream processes for bio-pharmaceutical separation and purification operations via microfiltration, ultrafiltration and diafiltration. Also the new technique of membrane chromatography allows efficient purification of monoclonal antibodies. Membrane filtration techniques of reverse osmosis and nanofiltration are being combined with bioreactors and advanced oxidation processes to treat wastewaters from pharmaceutical plants. Nanofiltration with organic solvent-stable membranes can implement solvent exchange and catalyst recovery during organic solvent-based drug synthesis of pharmaceutical compounds/intermediates. Membranes in the form of hollow fibers can be conveniently used to implement crystallization of pharmaceutical compounds. The novel crystallization methods of solid hollow fiber cooling crystallizer (SHFCC) and porous hollow fiber anti-solvent crystallization (PHFAC) are being developed to provide efficient methods for continuous production of polymer-coated drug crystals in the area of drug delivery. This brief review provides a general introduction to various applications of membrane technologies in

Restructuring the Production of Medicines: An Investigation on the Pharmaceutical Sector in China and the Role of Mergers and Acquisitions

Science.gov (United States)

Barbieri, Elisa; Huang, Manli; Pi, Shenglei; Tassinari, Mattia

2017-01-01

In places like China, an ageing population coupled with changes in living standards and increases in disposable income, imply a shift of the demand for health-related goods and services which is likely to affect the whole organization of the industries that supply such goods and services at the global level. One of the industries most likely to be affected is the pharmaceutical sector. In the early 2000s China was already the second largest global producer of pharmaceutical ingredients. The pharmaceutical sector has become one of the most important industries promoted by the Chinese government and Five-Year Plan of China’s Strategic Emerging Sectors, mergers and acquisition (M&A) activity has been the key strategy to restructure the sector and increase its competitiveness. This paper firstly provides an updated picture of the evolution of M&As in the pharmaceutical sector, compared to other sectors, in China in the period 2005–2013. Secondly, we develop a composite indicator to measure the industrial performance of all Chinese industrial sectors over time, which allows us to assess the performance of the pharmaceutical industry compared to that of other sectors of the Chinese economy. Finally, we develop and estimate an empirical model that tests the relationship between the number of M&A in a sector and its performance, with a particular focus on the pharmaceutical case. The results offer some initial evidence of positive effects from the process of restructuring of the pharmaceutical sector in China. PMID:28981463

Restructuring the Production of Medicines: An Investigation on the Pharmaceutical Sector in China and the Role of Mergers and Acquisitions.

Science.gov (United States)

Barbieri, Elisa; Huang, Manli; Pi, Shenglei; Tassinari, Mattia

2017-10-05

In places like China, an ageing population coupled with changes in living standards and increases in disposable income, imply a shift of the demand for health-related goods and services which is likely to affect the whole organization of the industries that supply such goods and services at the global level. One of the industries most likely to be affected is the pharmaceutical sector. In the early 2000s China was already the second largest global producer of pharmaceutical ingredients. The pharmaceutical sector has become one of the most important industries promoted by the Chinese government and Five-Year Plan of China's Strategic Emerging Sectors, mergers and acquisition (M&A) activity has been the key strategy to restructure the sector and increase its competitiveness. This paper firstly provides an updated picture of the evolution of M&As in the pharmaceutical sector, compared to other sectors, in China in the period 2005-2013. Secondly, we develop a composite indicator to measure the industrial performance of all Chinese industrial sectors over time, which allows us to assess the performance of the pharmaceutical industry compared to that of other sectors of the Chinese economy. Finally, we develop and estimate an empirical model that tests the relationship between the number of M&A in a sector and its performance, with a particular focus on the pharmaceutical case. The results offer some initial evidence of positive effects from the process of restructuring of the pharmaceutical sector in China.

[The pharmaceutical industry and the sustainability of healthcare systems in developed countries and in Latin America].

Science.gov (United States)

Iñesta, Antonio; Oteo, Luis Angel

2011-06-01

The global economic crisis and its impact on public finances in most developed countries are giving rise to cost-containment policies in healthcare systems. Prevailing legislation on medication requires the safety, quality, and efficacy of these products. A few countries include efficiency criteria, primarily for new medication that they wish to include in public financing. The appropriate use of generic and "biosimilar medication" is very important for maintaining the financial equilibrium of the Health Services. The problem in Latin America is that not all multisource products are bioequivalent and not all countries have the resources to conduct bioequivalence studies in vivo. The European Medicines Agency in 2005 adopted guidelines on "biosimilar medicines" and thirteen of them were subsequently approved for general release. Benchmarking of this model by other countries would be important. The influence of the pharmaceutical industry on political and administrative areas is enormous and control is necessary. The pharmaceutical companies claim that they act with corporate social responsibility, therefore, they must ensure this responsibility toward society.

Characteristics of physicians targeted by the pharmaceutical industry to participate in e-detailing.

Science.gov (United States)

Alkhateeb, Fadi M; Khanfar, Nile M; Doucette, William R; Loudon, David

2009-01-01

Electronic detailing (e-detailing) has been introduced in the last few years by the pharmaceutical industry as a new communication channel through which to promote pharmaceutical products to physicians. E-detailing involves using digital technology, such as Internet, video conferencing, and interactive voice response, by which drug companies target their marketing efforts toward specific physicians with pinpoint accuracy. A mail survey of 671 Iowa physicians was used to gather information about the physician characteristics and practice setting characteristics of those who are usually targeted by pharmaceutical companies to participate in e-detailing. A model is developed and tested to explain firms' targeting strategy for targeting physicians for e-detailing.

Nonclinical statistics for pharmaceutical and biotechnology industries

CERN Document Server

2016-01-01

This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The cha...

Assessment of Nelumbo nucifera and Hydrilla verticillata in the treatment of pharmaceutical industry effluent from 24 Parganas, West Bengal

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Shamba Chatterjee

2014-10-01

Full Text Available Modern day technologies employed in industrialization and unhygienic lifestyle of mankind has led to a severe environmental menace resulting in pollution of freshwater bodies. Pharmaceutical industry effluents cause eutrophication and provide adequate nutrients for growth of pathogenic bacteria. This study has been conducted with aquatic plants water lotus (Nelumbo nucifera and hydrilla (Hydrilla verticillata with an novel aim to treat pharmaceutical industry effluents showing the outcome of the experiments carried out with the effluents collected from rural areas of 24 Parganas, West Bengal, India. Determination of pH, solid suspend, BOD5, NH3-N, MPN and coliform test were used for this notioned purpose. Pharmaceutical waste effluent water treated with water lotus showed less pH, solid suspend, DO, BOD, NH3-N, MPN and coliform bacteria than hydrilla treatment when compared to the control. In conclusion, water lotus is found to be more efficient in treatment of pharmaceutical industry effluent waste water than hydrilla.

Collaborating to Compete: A Search into Capabilities and Strategic Alliances in the Pharmaceutical Industry

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Marisa Ohba

2007-06-01

Full Text Available Athough there is a profusion of studies related to strategic alliances and technological capacities which evaluate the issues individually, there is a scarcity of studies with empirical evidence relative to the implications of strategic alliances at the technological capacity configuration. Drawing on a scrutiny of specialised databases (Galé, Dialog, and Business & Industry covering the 1993-2003 period, this article examines the entry and exit composition of innovative capabilities of 25 pharmaceutical companies’ capabilities involved in such alliances. They are organised in three groups: (i large pharmaceutical companies (‘big-pharma’; (ii large bio-pharmaceutical companies (‘bio-pharma’; and (iii small and research-intensive companies. In terms of strategic alliance implications, a change was observed on the technological capacities’ configuration. The evidence suggests that the criteria for partner choice and technological capacity depend on the objectives and needs of each different group of company. Such type of evidence is important to provide researchers, corporate managers, and policy-makers with a concrete notion of the extent to which such division of innovative labour occurs and the actual changes going on the structure and organisation of innovative activities in the pharmaceutical industry.

Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.

Science.gov (United States)

Edwards, Brian

2004-01-01

The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose.

How can a policy foster local pharmaceutical production and still protect public health? Lessons from the health-industry complex in Brazil.

Science.gov (United States)

da Fonseca, Elize Massard

2018-04-01

The global health community is increasingly advocating for the local production of pharmaceuticals in developing countries as a way to promote technology transfer, capacity building and improve access to medicines. However, efforts to advance drug manufacturing in these countries revive an old dilemma of fostering technological development versus granting access to social services, such as healthcare. This paper explores the case of Brazil, a country that has developed large-scale health-inspired industrial policies, but is, yet, little understood. Brazil's experience suggests that progressive healthcare bureaucrats can create innovative practices for technology and knowledge transfers. It also demonstrates that highly competitive pharmaceutical firms can collaborate with each other, if a government provides them the right incentives. Reforming regulatory policies is crucial for guaranteeing high-quality products in developing countries, but governments must play a crucial role in supporting local firms to adapt to these regulations. These findings send a strong message to global health policymakers and practitioners on the conditions to create a suitable environment for local production of medical products.

Silo effect a prominence factor to decrease efficiency of pharmaceutical industry.

Science.gov (United States)

Vatanpour, Hossein; Khorramnia, Atoosa; Forutan, Naghmeh

2013-01-01

To be sure, all the industries try to be involved in globalization with a constant trend to find out ways to increase productivity across different functions within an organization to maintain competitive advantage world. Pharmaceutical industries are not exceptional and further are based on fragmentation. So these kind of companies need to cope with several barriers such as silo mentality that may affect efficiency of their business activity. Due to eliminate a part of resources such as raw materials, new molecule developed, financial and human resources and so on, companies can gradually loss their competitive potentials in the market and increase their expenses. Furthermore, to avoid any business disturbances in financially connected companies due to silo effect, they should arrange their management to integrated organization form. Otherwise, actions taken by one business member of the chain can influence the profitability of all the other members in the chain. That is why recently supply chain has generated much interest in many business units. In this paper, it has been tried to investigate the different aspects of silo effect which can affect integrate supply chain. Finally, a fluent communication, high level of information exchange, fragmentation management, cross-functional control in a supply chain management format are needed to reduce or control silo effect within entire chain of the holding company by Supply chain management.

Medications development for substance-use disorders: contextual influences (dis)incentivizing pharmaceutical-industry positioning.

Science.gov (United States)

Janero, David R

2014-11-01

The significant contribution of substance-use disorders (SUDs) to the global-disease burden and associated unmet medical needs has not engendered a commensurate level of pharma-industry research and development (R&D) for novel SUD therapeutics invention. Analysis of contextual factors shaping this position suggests potential routes toward incentivizing R&D commitment for that purpose. This article considers multiple primary factors that have consorted to disincentivize pharma industry's operating in the SUD space: ill-understood pathology; variegated treatments and patient profiles; involved clinical trials; and - with particular reference to SUDs-negative cultural/business stigmas and shallow commercial precedent. Industry incentivization for SUD drug innovation requires progress on several fronts, including: translational experimental data and systems; personalized, holistic SUD treatment approaches; interactions among pharma, nonindustry constituencies, and the medical profession with vested interests in countering negative stereotypes and expanding SUD treatment options; and public-private alliances focused on improving SUD pharmacotherapy. Given the well-entrenched business stance whereby the prospect of future profits in major markets largely determines drug-company R&D investment trajectory, strategic initiatives offering substantial reductions in the risks and opportunity (i.e., time and money) costs associated with SUD drug discovery are likely to be the most potent drivers for encouraging mainstream industry positioning in this therapeutic area. Such initiatives could originate from front-loaded R&D operational and back-loaded patent, regulatory, marketing and health-care policy reforms. These may be too involved and protracted for the turbulent pharmaceutical industry to entertain amid its recent retrenchment from psychiatric/CNS diseases and intense pressures to increase productivity and shareholder value.

77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

Science.gov (United States)

2012-10-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1010] Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical... certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs...

Measuring brand loyalty in the pharmaceutical industry of South Africa / Hilde du Plooy

OpenAIRE

Du Plooy, Hilde

2012-01-01

Brands are recognised as one of the most valuable assets that a company can possess and therefore brands are key role-players in the business strategies of organisations. The rivalry amongst competitors in the pharmaceutical industry is fierce and companies should design their strategies in such a way in order to achieve competitive advantage. Brand loyalty is regarded as a powerful tool in the development of pharmaceutical brands. The main aim of this study was to measure b...

What do pharmaceutical industry professionals in Europe believe about involving patients and the public in research and development of medicines? A qualitative interview study.

Science.gov (United States)

Parsons, Suzanne; Starling, Bella; Mullan-Jensen, Christine; Tham, Su-Gwan; Warner, Kay; Wever, Kim

2016-01-07

To explore European-based pharmaceutical industry professionals' beliefs about patient and public involvement (PPI) in medicines research and development (R&D). Pharmaceutical companies in the UK, Poland and Spain. 21 pharmaceutical industry professionals, four based in the UK, five with pan-European roles, four based in Spain and eight based in Poland. Qualitative interview study (telephone and face-to-face, semistructured interviews). All interviews were audio taped, translated (where appropriate) and transcribed for analysis using the Framework approach. 21 pharmaceutical industry professionals participated. Key themes were: beliefs about (1) whether patients and the public should be involved in medicines R&D; (2) the barriers and facilitators to PPI in medicines R&D and (3) how the current relationships between the pharmaceutical industry, patient organisations and patients influence PPI in medicines R&D. Although interviewees appeared positive about PPI, many were uncertain about when, how and which patients to involve. Patients and the public's lack of knowledge and interest in medicines R&D, and the pharmaceutical industry's lack of knowledge, interest and receptivity to PPI were believed to be key challenges to increasing PPI. Interviewees also believed that relationships between the pharmaceutical industry, patient organisations, patients and the public needed to change to facilitate PPI in medicines R&D. Existing pharmaceutical industry codes of practice and negative media reporting of the pharmaceutical industry were also seen as negative influences on these relationships. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The Pharmaceutical Industry and the Canadian Government: Folie à Deux.

Science.gov (United States)

Lexchin, Joel

2017-08-01

The interest of the pharmaceutical industry is in achieving a profit for its shareholders while the interest of the Canadian government should be in protecting public health. However, over the course of the past few decades the actions of the Canadian government have been tilted in favour of industry in two areas. The first is in the relationship between industry and Health Canada and is manifested in the regulation of clinical trials, the drug approval system, drug safety and promotion. The second is in economic policy as it applies to policies about patent protection, the price of medications and measures taken to incentivize research and development. The problems in the relationship are structural and will only be solved through systemic changes. Copyright © 2017 Longwoods Publishing.

Implications of nuclear industry globalization for chinese nuclear industry: opportunities and challenges

International Nuclear Information System (INIS)

Guo Zhifeng; Ding Qihua; Wang Zheng

2014-01-01

In recent years, globalization of the world nuclear industry has developed into a new phase. Chinese nuclear industry will be inevitably integrated into this trend. Globalization will bring both positive and adverse effects on Chinese nuclear industry. Facing the fierce competition, Chinese companies must rise to many challenges to enter the global nuclear market. And China need to make scientific decisions and take effective measures in various fields of nuclear industry to realized the goal of global development. (authors)

Restructuring the Production of Medicines: An Investigation on the Pharmaceutical Sector in China and the Role of Mergers and Acquisitions

Directory of Open Access Journals (Sweden)

Elisa Barbieri

2017-10-01

Full Text Available In places like China, an ageing population coupled with changes in living standards and increases in disposable income, imply a shift of the demand for health-related goods and services which is likely to affect the whole organization of the industries that supply such goods and services at the global level. One of the industries most likely to be affected is the pharmaceutical sector. In the early 2000s China was already the second largest global producer of pharmaceutical ingredients. The pharmaceutical sector has become one of the most important industries promoted by the Chinese government and Five-Year Plan of China’s Strategic Emerging Sectors, mergers and acquisition (M&A activity has been the key strategy to restructure the sector and increase its competitiveness. This paper firstly provides an updated picture of the evolution of M&As in the pharmaceutical sector, compared to other sectors, in China in the period 2005–2013. Secondly, we develop a composite indicator to measure the industrial performance of all Chinese industrial sectors over time, which allows us to assess the performance of the pharmaceutical industry compared to that of other sectors of the Chinese economy. Finally, we develop and estimate an empirical model that tests the relationship between the number of M&A in a sector and its performance, with a particular focus on the pharmaceutical case. The results offer some initial evidence of positive effects from the process of restructuring of the pharmaceutical sector in China.

Measuring the efficiency of large pharmaceutical companies: an industry analysis.

Science.gov (United States)

Gascón, Fernando; Lozano, Jesús; Ponte, Borja; de la Fuente, David

2017-06-01

This paper evaluates the relative efficiency of a sample of 37 large pharmaceutical laboratories in the period 2008-2013 using a data envelopment analysis (DEA) approach. We describe in detail the procedure followed to select and construct relevant inputs and outputs that characterize the production and innovation activity of these pharmaceutical firms. Models are estimated with financial information from Datastream, including R&D investment, and the number of new drugs authorized by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) considering the time effect. The relative performances of these firms-taking into consideration the strategic importance of R&D-suggest that the pharmaceutical industry is a highly competitive sector given that there are many laboratories at the efficient frontier and many inefficient laboratories close to this border. Additionally, we use data from S&P Capital IQ to analyze 2071 financial transactions announced by our sample of laboratories as an alternative way to gain access to new drugs, and we link these transactions with R&D investment and DEA efficiency. We find that efficient laboratories make on average more financial transactions, and the relative size of each transaction is larger. However, pharmaceutical companies that simultaneously are more efficient and invest more internally in R&D announce smaller transactions relative to total assets.

Financial aspects and the future of the pharmaceutical industry in the United States of america.

Science.gov (United States)

Karamehic, Jasenko; Ridic, Ognjen; Ridic, Goran; Jukic, Tomislav; Coric, Jozo; Subasic, Djemo; Panjeta, Mirsad; Saban, Aida; Zunic, Lejla; Masic, Izet

2013-12-01

The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as "companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use". Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers' lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays. The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. THIS PAPER REPRESENTS A THOROUGH LITERATURE REVIEW OF THE MULTIFACETED SOURCES INCLUDING: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.). In the thirty years pharmaceutical companies have consistently developed and launched new medicines, bringing hope to sick or - at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceutical companies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceutical companies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end. Numerous blockbuster drugs will be coming off patent in the next few years, opening the way to generics and

A quality by design study applied to an industrial pharmaceutical fluid bed granulation.

Science.gov (United States)

Lourenço, Vera; Lochmann, Dirk; Reich, Gabriele; Menezes, José C; Herdling, Thorsten; Schewitz, Jens

2012-06-01

The pharmaceutical industry is encouraged within Quality by Design (QbD) to apply science-based manufacturing principles to assure quality not only of new but also of existing processes. This paper presents how QbD principles can be applied to an existing industrial pharmaceutical fluid bed granulation (FBG) process. A three-step approach is presented as follows: (1) implementation of Process Analytical Technology (PAT) monitoring tools at the industrial scale process, combined with multivariate data analysis (MVDA) of process and PAT data to increase the process knowledge; (2) execution of scaled-down designed experiments at a pilot scale, with adequate PAT monitoring tools, to investigate the process response to intended changes in Critical Process Parameters (CPPs); and finally (3) the definition of a process Design Space (DS) linking CPPs to Critical to Quality Attributes (CQAs), within which product quality is ensured by design, and after scale-up enabling its use at the industrial process scale. The proposed approach was developed for an existing industrial process. Through enhanced process knowledge established a significant reduction in product CQAs, variability already within quality specifications ranges was achieved by a better choice of CPPs values. The results of such step-wise development and implementation are described. Copyright © 2012 Elsevier B.V. All rights reserved.

Global gene mining and the pharmaceutical industry

DEFF Research Database (Denmark)

Knudsen, Lisbeth Ehlert

2005-01-01

for the Evaluation of Medicinal Products (EMEA) having issued a position paper, the Council for International Organizations of Medical Sciences (CIOMS) having a working group on this issue, and the European Society of Human Genetics preparing background paper on 'Polymorphic sequence variants in medicine: Technical...... may stigmatize patients leading to poor quality of life. This has raised the issue of 'genetic exceptionalism' justifying specific regulation of use of genetic information. Discussions on how to handle sampling and data are ongoing within the industry and the regulatory sphere, the European Agency......, social, legal and ethical issues. Pharmacogenetics as an example'. Within the European project Privacy in Research Ethics and Law (PRIVIREAL), recommendations for common European guidelines for membership in research ethical committees have been discussed, balancing the interests and assuring...

Method æ, the agile software development method tailored for the pharmaceutical industry.

NARCIS (Netherlands)

Hajou, A.; Batenburg, R.S.; Jansen, S.

2015-01-01

Agile software development methods have a high adoption rate due to their proven business benefits. Its success has not yet been identified in the pharmaceutical industry, due to the industry’s incompatibility with generic agile methods. Comprehensive research has been done to engineer a tailored

Understanding evolutionary processes in non-manufacturing industries: Empirical insights from the shakeout in pharmaceutical wholesaling

OpenAIRE

Adam J. Fein

1998-01-01

Although the empirical pattern of industry shakeout has been documented for many manufacturing industries, we know little about the processes by which market structure evolves in non-manufacturing service industries. This paper establishes detailed empirical observations about the consolidation of a single non-manufacturing industry, the wholesale distribution of pharmaceuticals. These observations are used to explore differences between manufacturing and wholesaling in both the patterns and ...

Bioremediation Kinetics of Pharmaceutical Industrial Effluent

OpenAIRE

M. Šabić; M. Vuković Domanovac; Z. Findrik Blažević; E. Meštrović

2015-01-01

In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmente...

Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure.

Science.gov (United States)

Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo

2004-06-01

This paper investigates patterns of industrial dynamics and competition in the pharmaceutical industry, with particular reference to the consequences of patent expiry in different countries. We focus on the competition at the level of single chemical entities, distinguishing between original brands and generic products. Quarterly data, spanning from July 1987 to December 1998, on sales of pharmaceutical products in four countries (USA, UK, Germany, and France) constitute the basis of our analysis. All the products containing major molecules whose patent expiration date lies between 1986 and 1996 are included in our sample. We show how diffusion of generics is linked to the characteristics of the market and investigate how price dynamics of original products are affected by generic competition. Our empirical investigation shows that the dynamics of drug prices and the competition by generic drugs vary significantly across countries. This heterogeneity notwithstanding, a clear distinction seems to emerge. On the one hand, systems that rely on market-based competition in pharmaceuticals promote a clear distinction between firms that act as innovators and firms that act as imitators after patent expiry. Here, original products enjoy premium prices and exclusivity profits under patent protection, and face fierce price competition after patent expiry. On the other hand, in systems that rely on administered prices, penetration by generic drugs tends to be rather limited. Its descriptive and preliminary nature notwithstanding, our analysis seems to have relevant implications at different levels of generality, especially for Europe.

Understanding Pharmaceutical Sustainable Supply chains - A Case Study Application

Directory of Open Access Journals (Sweden)

Ana Margarida Santos Bravo

2013-06-01

Full Text Available A major paradigmchange is occurring in the pharmaceutical industry and an increase of returnsand recalls has been seen; although this industry in known for the continuoussearch for quality and regulatory compliance.Hence, in this paperwe combine the findings of previous literature reviews conducted by theauthors. Essentially, explore the links between pharmaceutical drugs quality,reverse logistics, and sustainability. A case study on a global corporationmanufacturing in the area of generic drug products has been selected andcorrelations are done with regards to returns and recalls from hospitalpharmacies, in particular. With this approach it is expected to link bothparties in the application of a quality by design risk management approach aswell as reduce variability and risk of noncompliance.

Markets and Molecules: A Pharmaceutical Primer from the South.

Science.gov (United States)

Banerjee, Dwaipayan

2017-01-01

The Indian pharmaceutical industry has historically manufactured low-cost drugs for the global poor. Activist mobilizations at the height of the HIV/AIDS epidemic revealed a vast cost gap between global brands and Indian generics, much to the embarrassment of Euro-American corporations that were in the habit of pricing drugs for only the wealthy or well insured. As new drug access controversies focus on anticancer therapies, they reveal new flows of international capital, emergent genetic technologies, and increasingly coercive trade regimes. Together these favor multinational corporate oligopolies, which imperil the legacy of HIV/AIDS activism and the future availability of essential life-saving drugs for the work of global public health. In this essay, I describe how the future of the right to drug access rests uneasily, and potentially calamitously, on a shifting balance of power between global south interests and Euro-American pharmaceutical capital.

An insight into the emerging role of regional medical advisor in the pharmaceutical industry

Directory of Open Access Journals (Sweden)

Sandeep Kumar Gupta

2013-01-01

Full Text Available The position of regional medical advisor (RMA is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry′s increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP guidelines.

The devil is in the details: the pharmaceutical industry's use of gifts to physicians as marketing strategy.

Science.gov (United States)

McFadden, David W; Calvario, Elizabeth; Graves, Cynthia

2007-06-01

Marketing costs exceed 30% of revenues for the pharmaceutical industry, with over 90% of the effort aimed at physicians. Although there are currently unprecedented numbers of regulatory activities focusing on relationships between the pharmaceutical industry and the medical profession, such legislation is often unrecognized or flouted. The potential influence, although minimized by both parties, must not be ignored. Physicians and drug companies will need to re-evaluate their responsibilities to their patients and their shareholders, and both groups should assume proactive and guidance roles in the transformation.

Clustering as a determinant of development the competitive pharmaceutical industry - example of Nutribiomed cluster

Directory of Open Access Journals (Sweden)

Anna Skowrońska

2015-04-01

Full Text Available Continuous improvement and follow the technology seems to be particularly important in terms of health. Given the epidemiological trends is necessary to develop advanced technologies in the medical and pharmaceutical industries. Only innovative solutions offer a chance for a battle with disease, for example, with tumors which are one of the leading causes of death in Europe. This approach perfectly illustrates the strategy known as open innovation, according to which companies should learn from external sources by combining complementary ideas for its ongoing operations. The pharmaceutical industry has a significant impact on the functioning of not only the economy, but it is also closely linked to the health sector, and thus affects the level and quality of life of societies. In this context it becomes particularly important to seek solutions that will ensure the free flow of knowledge and access to highly specialized techniques, which in turn have a positive impact on the health of citizens. Analysis of the functioning of the pharmaceutical clusters is based on case study cluster Nutribiomed. The results achieved in many areas of activity confirm the legitimate use of the structure of the group of highly specialized industry, which is the drug market and indicates a number of benefits associated with the operation as part of its structure.

Generic versus innovator: Analysis of the pharmaceutical qualities of ...

African Journals Online (AJOL)

owner

1Department of Pharmaceutics and Industrial Pharmacy, Faculty of ... ibuprofen tablets sourced from retail Pharmacy outlets in the Nigerian market to their ... However, five brands of paracetamol failed the friability test, one brand of ... Asian countries to combat the global threat ... of proving the safety and efficacy of the drugs.

Basic pharmaceutical technology

OpenAIRE

Angelovska, Bistra; Drakalska, Elena

2017-01-01

The lecture deals with basics of pharmaceutical technology as applied discipline of pharmaceutical science, whose main subject of study is formulation and manufacture of drugs. In a broad sense, pharmaceutical technology is science of formulation, preparation, stabilization and determination of the quality of medicines prepared in the pharmacy or in pharmaceutical industry

Emerging trends in contract research industry in India.

Science.gov (United States)

Drabu, Sushma; Gupta, Alka; Bhadauria, Anupama

2010-09-01

A Contract Research Organization (CRO) is a service organization that provides support to the pharmaceutical industry and offers a wide range of "outsourced" pharmaceutical research services to aid in R&D process and is thus an essential tool for undertaking clinical trials in the present scenario when high stakes are involved in the drug discovery process. This industry also offers a safe option of investment as the industry is largely recession-proof, with a significant upscale growth. Presently India occupies a very small pie of the global market share in the Clinical Trials Industry but it is estimated to conduct nearly 5% of global clinical trials by 2012. The global CRO industry valued $18 bn in 2008 and the market is expected to grow at an annual rate of 14% between 2009 and 13. Top multinational pharmaceuticals companies are venturing into the Indian business, in collaboration with the Indian Drug Companies. According to a recent study by Mckinsey & Company, the Indian Clinical Research Industry can attract $1.5 bn of revenue from US and EU by 2010. Such an increase in outsourcing from the western countries has led the global pharma companies and Indian entrepreneurs to set up Contract Research Organizations (CROs) in India. To bring this into realization and fulfil the market demand, while simultaneously aiding in improving the country's economical standards and market position, joint and well-coordinated efforts on part of the government, industry, and working professionals are needed in terms of regulatory affairs, audits, transparency in work affairs, garnering patient confidence, and pharmacovigilance. Copyright 2010 Elsevier Inc. All rights reserved.

[Early achievements of the Danish pharmaceutical industry-6 Pharmacia].

Science.gov (United States)

Grevsen, Jørgen V; Kruse, Edith; Kruse, Poul R

2014-01-01

The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 6 deals with products from A/S Pharmacia. A/S Pharmacia was established in Copenhagen in 1922 as a Danish limited company by the enterprising pharmacist Edward Jacobsen. Pharmacia was not Jacobsen's first pharmaceutical company as previously he had established a pharmaceutical agency already in 1913 which in 1919 was reorganized to a limited company by the name of A/S Edward Jacobsen. This agency was later extended to include a production of generics. Jacobsen remained the co-owner and manager of Pharmacia until 1934 where he resigned and established another company, A/S Ejco, for the manufacture of generics. It is worth mentioning that already in 1911 a Swedish pharmaceutical company was established named AB Pharmacia. Today we do not know whether Edward Jacobsen knew about this Swedish company. Later on in 1936 AB Pharmacia and A/S Pharmacia made a contract concerning mutual market sharing, and a research cooperation was brought about between the two companies which resulted in an increase of turnover for A/S Pharmacia. In 1955 the cooperation between the two companies was increased as the Swedish company joined as principal shareholder with the purpose of continuing and developing the Danish company as an independent pharmaceutical company with its own research and development as well as manufacture, control and marketing. Therefore Pharmacia in Denmark was able to establish a synthesis factory in Koge and move the domicile to new premises in Hillered. In 1993 Pharmacia was presented in a printed matter as "The largest Nordic pharmaceutical company" as a result of the merger between the Swedish Kabi Pharmacia, formerly established by a merger between Kabi Vitrum and AB Pharmacia, and the Italian Farmitalia Carlo Erba. Only two years later in 1995 Pharmacia merged with the American pharmaceutical company The

The development of a self-sufficient pharmaceutical industry in autarchic Spain: between need, utopia and fracoist propaganda

Directory of Open Access Journals (Sweden)

Raúl Rodríguez Nozal

2017-06-01

Full Text Available The history of the Spanish pharmaceutical industry is conditioned by its ascription to a Mediterranean model, with small economic impact and a high presence of artisan and professional elements. The industry of organic and fermentative raw materials did not appear until the Franco dictatorship. During the autarchy period, an interest to stimulate the sector seems to have arose: first, by continuing the long going investment on industries of natural products to obtain medical active principles, hence preventing their import; secondly, aimed at long term, by establishing an integral organic chemistry industry to obtain drugs from coal; and finally, by promoting the development of an industry of penicillin synthesis. However, there were a number of elements that hindered the development of the chemical-pharmaceutical industry, including the inherent limitations of the autarchic policies, the excessive number of laboratories and commercialized products, the poor capitalization and lack of research programs of these companies and the insufficient technical and scientific abilities required for these activities.

Expectations and satisfaction of academic investigators in nonclinical collaboration with the pharmaceutical industry.

Science.gov (United States)

Amiri, Marjan; Michel, Martin C

2015-06-01

In light of a growing role of research collaborations between academia and the pharmaceutical industry, we have explored expectations and experience of academic investigators with preclinical collaborations. Researchers from Western Europe, North America, and Japan with preclinical publications in the obstructed airways or diabetes fields were invited to anonymously participate in a web-based survey. A total of 134 investigators (28 % of invitees) participated in the two sequentially performed surveys with similar responses in both therapeutic areas. A secondary but prespecified subgroup analysis was based on region of residence, gender, and career level of the investigator. Across all groups, responders considered freedom to publish, obtaining funding and obtaining compounds to be the most important objectives of nonclinical collaborations with the pharmaceutical industry, whereas cultivating professional relationships, getting external scientific input, direct relationship to disease treatment, and involvement with drug development were less important. Among eight attributes of the primary contact person in the company, trustworthiness ranked highest, followed by a collaborative spirit and transparent information sharing; supportiveness, scientific qualification, accessibility, and timeliness of responses ranked lower, and friendliness, lowest. Related to their most recent collaboration, investigators also expressed the highest level of satisfaction with the trustworthiness attribute. On the other hand, the process of reaching a contract was often considered too long and difficult, for which both university and company legal departments were reported as culprits. We conclude that academic researchers are generally satisfied with their preclinical collaboration with the pharmaceutical industry but look for improved contracting procedures.

Business Ethics and CSR in Pharmaceutical Industry in the Czech Republic and Hungary?

Directory of Open Access Journals (Sweden)

Markéta Lőrinczy

2015-01-01

Full Text Available How do business ethics and CSR form part of pharmaceutical business in the Czech Republic and Hungary? The question was analyzed through empirical studies where surveys were the main tool. The research investigated business ethics, CSR, ethical code, ethical involvement of employees as factors that might be important to achieve ethical behaviour in the pharmaceutical industry. Results showed that, with 69.4% response rate, that Czech and Hungarian original companies are more towards ethical behaviour and the employees know more about the organization they work for. The data were compared with parametric statistical analysis based on Mann-Whitney U calculator.

Creating knowledge structures in the pharmaceutical industry: the increasing significance of virtual organisation.

Science.gov (United States)

Salazar, A; Howells, J

2000-01-01

This paper explores the specific trend and challenges facing the pharmaceutical industry regarding the exploitation of Internet e-commerce technology and virtual organisation to develop and maintain competitive advantage. There are two important facets of the current trend. One is the rapid development of a complex network of alliances between the established pharmaceutical companies and the specialised biotechnology company start-ups. The other is the rapid growth of internet e-commerce companies dedicated to developing specialised technological platforms for acquiring and selling genetic and biochemical knowledge. The underlying challenge is how big pharmaceutical companies can emulate some of the innovation processes of smaller biotechnology company start-ups, and how they can appropriate and applied new technological knowledge on the development of new drugs. Pharmaceutical companies in order to retain competitive advantage need to continuously monitor all aspects of knowledge management with regard to the R&D and manufacturing process (as well as customer management and marketing). Technological change and organisational restructuring should be aimed at boosting the capacity of large firms to innovate rapidly.

Organic Colouring Agents in the Pharmaceutical Industry

Directory of Open Access Journals (Sweden)

Šuleková M.

2017-09-01

Full Text Available Food dyes are largely used in the process of manufacturing pharmaceutical products. The aim of such a procedure is not only to increase the attractiveness of products, but also to help patients distinguish between pharmaceuticals. Various dyes, especially organic colouring agents, may in some cases have a negative impact on the human body. They are incorporated into pharmaceutical products including tablets, hard gelatine capsules or soft gelatine capsules, lozenges, syrups, etc. This article provides an overview of the most widely used colouring agents in pharmaceuticals, their characteristics and the EU legislation which regulates their use.

The global alcohol industry: an overview.

Science.gov (United States)

Jernigan, David H

2009-02-01

To describe the globalized sector of the alcoholic beverage industry, including its size, principal actors and activities. Market research firms and business journalism are the primary sources for information about the global alcohol industry, and are used to profile the size and membership of the three main industry sectors of beer, distilled spirits and wine. Branded alcoholic beverages are approximately 38% of recorded alcohol consumption world-wide. Producers of these beverages tend to be large multi-national corporations reliant on marketing for their survival. Marketing activities include traditional advertising as well as numerous other activities, such as new product development, product placement and the creation and promotion of social responsibility programs, messages and organizations. The global alcohol industry is highly concentrated and innovative. There is relatively little public health research evaluating the impact of its many marketing activities.

Network on veterinary medicines initiated by the European Federation For Pharmaceutical Sciences.

Science.gov (United States)

Mochel, J P; Tyden, E; Hellmann, K; Vendrig, J C; Şenel, S; Dencker, L; Cristina, R T; Linden, H; Schmerold, I

2018-06-01

The European Federation for Pharmaceutical Sciences (EUFEPS) was founded 25 years ago by more than 20 national pharmaceutical societies and faculty members. As a pan-European organization, it brings together pharmaceutical societies as well as academic, industrial and regulatory scientists engaged in drug research and development, drug regulation and education of professionals working in these fields. EUFEPS represents pharmaceutical sciences in Europe and is recognized as such by both the European Commission and the European Medicines Agency. EUFEPS cooperates with the European Federation of Pharmaceutical Industries and other European organizations and maintains global connections with agencies such as the US Food and Drug Administration and the American Association of Pharmaceutical Scientists. EUFEPS has established specified networks forming the basis of its activities. The creation of a Network on Veterinary Medicines is prompted by the manifold problems resulting from the use of veterinary drugs and its inherent interconnections with human medicine, environmental and public health. A long-term goal of this initiative was to expand the spectrum of available therapeutics for use in animals, including the development of innovative delivery systems. © 2017 John Wiley & Sons Ltd.

Nurse practitioners' perceptions and participation in pharmaceutical marketing.

Science.gov (United States)

Crigger, Nancy; Barnes, Kristen; Junko, Autumn; Rahal, Sarah; Sheek, Casey

2009-03-01

This paper reports on a study conducted to describe family nurse practitioners' perceptions towards and participation in pharmaceutical marketing and to explore the relationships among related variables. The pharmaceutical industry's intense global marketing strategies have resulted in widespread concern in healthcare professionals and professional groups, sectors of the public in many countries, and in the World Health Organization. Research on healthcare providers' participation in pharmaceutical marketing indicates that these relationships are conflicts of interests and compromise healthcare providers' prescribing practices and trust. Nursing, as a discipline, appears to be slow to address the impact of pharmaceutical marketing on nursing practice. Questionnaires about perceptions and participation in pharmaceutical marketing were completed by a random sample of 84 licensed family nurse practitioners in the United States of America in 2007. Family nurse practitioners viewed pharmaceutical company marketing uncritically as educational and beneficial. They also perceived other providers but not themselves as influenced by pharmaceutical marketing. The findings supported those found in previous research with nurses and physicians. Lack of education, participation in marketing and psychological and social responses may impede family nurse practitioners' ability to respond critically and appropriately to marketing strategies and the conflict of interest it creates.

Does brand differentiate pharmaceuticals?

Science.gov (United States)

Bednarik, Josef

2005-12-01

Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.

Heterogeneous batch distillation processes for waste solvent recovery in pharmaceutical industry

OpenAIRE

Rodriguez-Donis, Ivonne; Gerbaud, Vincent; Arias-Barreto, Alien; Joulia, Xavier

2009-01-01

A summary about our experiences in the introduction of heterogeneous entrainers in azeotropic and extractive batch distillation is presented in this work. Essential advantages of the application of heterogeneous entrainers are showed by rigorous simulation and experimental verification in a bench batch distillation column for separating several azeotropic mixtures such as acetonitrile – water, n hexane – ethyl acetate and chloroform – methanol, commonly found in pharmaceutical industry.

Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

Science.gov (United States)

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time. We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials. 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%). Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are

Gamma radiodecontamination of natural products uses in Cuban pharmaceutical industry

International Nuclear Information System (INIS)

Rodriguez, M.; Lopez, M.; Guerra, M.; Lastra, H.; Prieto, E.; Padron, E.

1997-01-01

The aim of the present paper was to carry out the gamma radiodecontamination of industrial productions from there medicinal plant species (C. officinalis, P. incarta and M. recuttia) and two pharmaceuticals forms (S. platensis and bee pollen tabs) which presented high levels of microbiological count. Adequate irradiation doses calculated for each product were used in decontamination. The results obtained showed the effectiveness of the process in the elimination of microbial contamination from theses natural products. No changes in nutritional constituents or physico-chemical properties were observed

Tobacco industry globalization and global health governance: towards an interdisciplinary research agenda

Science.gov (United States)

Lee, Kelley; Eckhardt, Jappe; Holden, Chris

2016-01-01

Shifting patterns of tobacco production and consumption, and the resultant disease burden worldwide since the late twentieth century, prompted efforts to strengthen global health governance through adoption of the Framework Convention on Tobacco Control. While the treaty is rightfully considered an important achievement, to address a neglected public health issue through collective action, evidence suggests that tobacco industry globalization continues apace. In this article, we provide a systematic review of the public health literature and reveal definitional and measurement imprecision, ahistorical timeframes, transnational tobacco companies and the state as the primary units and levels of analysis, and a strong emphasis on agency as opposed to structural power. Drawing on the study of globalization in international political economy and business studies, we identify opportunities to expand analysis along each of these dimensions. We conclude that this expanded and interdisciplinary research agenda provides the potential for fuller understanding of the dual and dynamic relationship between the tobacco industry and globalization. Deeper analysis of how the industry has adapted to globalization over time, as well as how the industry has influenced the nature and trajectory of globalization, is essential for building effective global governance responses. This article is published as part of a thematic collection dedicated to global governance. PMID:28458910

Tobacco industry globalization and global health governance: towards an interdisciplinary research agenda.

Science.gov (United States)

Lee, Kelley; Eckhardt, Jappe; Holden, Chris

2016-01-01

Shifting patterns of tobacco production and consumption, and the resultant disease burden worldwide since the late twentieth century, prompted efforts to strengthen global health governance through adoption of the Framework Convention on Tobacco Control. While the treaty is rightfully considered an important achievement, to address a neglected public health issue through collective action, evidence suggests that tobacco industry globalization continues apace. In this article, we provide a systematic review of the public health literature and reveal definitional and measurement imprecision, ahistorical timeframes, transnational tobacco companies and the state as the primary units and levels of analysis, and a strong emphasis on agency as opposed to structural power. Drawing on the study of globalization in international political economy and business studies, we identify opportunities to expand analysis along each of these dimensions. We conclude that this expanded and interdisciplinary research agenda provides the potential for fuller understanding of the dual and dynamic relationship between the tobacco industry and globalization. Deeper analysis of how the industry has adapted to globalization over time, as well as how the industry has influenced the nature and trajectory of globalization, is essential for building effective global governance responses. This article is published as part of a thematic collection dedicated to global governance.

Determinants of FDI Localization in China: A County-Level Analysis for the Pharmaceutical Industry.

Science.gov (United States)

Li, Su; Angelino, Antonio; Yin, Haitao; Spigarelli, Francesca

2017-08-30

Foreign direct investments (FDIs) have been widely recognized as a crucial feature of the Chinese industrial development process. Over the past decades, China has been attracting huge amounts of inward FDIs as a consequence of both spontaneous market dynamics and place-based preferential policies at the sub-national level. However, the Chinese market exhibits large dissimilarities in terms of FDI localization across territories that are worth investigating at a more disaggregated level. In this regards, our study explores the determinants of attraction of inward FDIs in China, at the county level. It focuses on the pharmaceutical industry and attempts to assess whether factors related to location advantages, agglomeration dynamics, information cost effects and environmental regulation costs affect foreign firms' localization choices as well as invested amounts in that location. By means of discrete choice models, our paper confirms the findings of the prevalent literature about the positive effects of location advantages on pharmaceutical FDI attraction. Different from our expectations, a higher proportion of foreign enterprises do not stimulate significant effects on FDI localization, while preferential policies and sectoral agglomeration are positively correlated with the localization of pharmaceutical foreign firms. Finally, our results suggest that investing firms tend to avoid areas with strict environment regulation.

Assessment of global industrial-age anthropogenic arsenic contamination.

Science.gov (United States)

Han, Fengxiang X; Su, Yi; Monts, David L; Plodinec, M John; Banin, Amos; Triplett, Glover E

2003-09-01

Arsenic, a carcinogenic trace element, threatens not only the health of millions of humans and other living organisms, but also global sustainability. We present here, for the first time, the global industrial-age cumulative anthropogenic arsenic production and its potential accumulation and risks in the environment. In 2000, the world cumulative industrial-age anthropogenic arsenic production was 4.53 million tonnes. The world-wide coal and petroleum industries accounted for 46% of global annual gross arsenic production, and their overall contribution to industrial-age gross arsenic production was 27% in 2000. Global industrial-age anthropogenic As sources (as As cumulative production) follow the order: As mining production>As generated from coal>As generated from petroleum. The potential industrial-age anthropogenic arsenic input in world arable surface in 2000 was 2.18 mg arsenic kg(-1), which is 1.2 times that in the lithosphere. The development of substitute materials for arsenic applications in the agricultural and forestry industries and controls of arsenic emissions from the coal industry may be possible strategies to significantly decrease arsenic pollution sources and dissipation rates into the environment.

The epiphany of data warehousing technologies in the pharmaceutical industry.

Science.gov (United States)

Barrett, J S; Koprowski, S P

2002-03-01

The highly competitive pharmaceutical industry has seen many external changes to its landscape as companies consume each other increasing their pipelines while removing redundant functions and processes. Internally, companies have sought to streamline the discovery and development phases in an attempt to improve candidate selection and reduce the time to regulatory filing. In conjunction with efforts to screen and develop more compounds faster and more efficiently, database management systems (DBMS) have been developed for numerous groups supporting various R&D efforts. An outgrowth of DBMS evolution has been the birth of data warehousing. Often confused with DBMS, data warehousing provides a conduit for data residing across platforms, networks, and in different data structures. Through the use of metadata, the warehouse establishes connectivity of varied data stores (operational detail data, ODD) and permits identification of data ownership, location and transaction history. This evolution has closely mirrored and in some ways been driven by the electronic submission (formerly CANDA). The integration of the electronic submissions and document management with R&D data warehousing initiatives should provide a platform by which companies can address compliance with 21 CFR Part 11. Now more than ever "corporate memory" is being extended to the data itself. The when, why and how of successes and failures are constantly being probed by R&D management teams. The volume of information being generated by today's pharmaceutical companies requires mining of historical data on a routine basis. Data warehousing represents a core technology to assist in this endeavor. New initiatives in this field address the necessity of data portals through which warehouse data can be web-enabled and exploited by diverse data customers both internal and external to the company. The epiphany of data warehousing technologies within the pharmaceutical industry has begun and promises to change

Pharmaceutical product cross-contamination: industrial and clinical ...

African Journals Online (AJOL)

problems. Pharmaceutical product cross-contamination is a serious problem which has been detected as an obstacle ... In the pharmaceutical care of patients in developed countries, cross-contamination ..... neonatal intensive care units.

Individual capacity-building approaches in a global pharmaceutical systems strengthening program: a selected review.

Science.gov (United States)

Konduri, Niranjan; Rauscher, Megan; Wang, Shiou-Chu Judy; Malpica-Llanos, Tanya

2017-01-01

Medicines use related challenges such as inadequate adherence, high levels of antimicrobial resistance and preventable adverse drug reactions have underscored the need to incorporate pharmaceutical services to help achieve desired treatment outcomes, and protect patients from inappropriate use of medicines. This situation is further constrained by insufficient numbers of pharmaceutical personnel and inappropriate skill mix. Studies have addressed individual capacity building approaches of logistics, supply chain or disease specific interventions but few have documented those involving such pharmacy assistants/professionals, or health workers/professionals charged with improving access and provision of pharmaceutical services. We examined how different training modalities have been employed and adapted to meet country-specific context and needs by a global pharmaceutical systems strengthening program in collaboration with a country's Ministry of Health and local stakeholders. Structured, content analysis of training approaches from twelve selected countries and a survey among conveniently selected trainees in Bangladesh and Ethiopia. Case-based learning, practice and feedback, and repetitive interventions such as post-training action plan, supportive supervision and mentoring approaches are effective, evidence-based training techniques. In Ethiopia and Bangladesh, over 94% of respondents indicated that they have improved or developed skills or competencies as a result of the program's training activities. Supportive supervision structures and mentorship have been institutionalized with appropriate management structures. National authorities have been sensitized to secure funding from domestic resources or from the global fund grants for post-training follow-up initiatives. The Pharmaceutical Leadership Development Program is an effective, case-based training modality that motivates staff to develop quality-improvement interventions and solve specific challenges

Accounting- versus economic-based rates of return: implications for profitability measures in the pharmaceutical industry.

Science.gov (United States)

Skrepnek, Grant H

2004-01-01

Accounting-based profits have indicated that pharmaceutical firms have achieved greater returns relative to other sectors. However, partially due to the theoretically inappropriate reporting of research and development (R&D) expenditures according to generally accepted accounting principles, evidence suggests that a substantial and upward bias is present in accounting-based rates of return for corporations with high levels of intangible assets. Given the intensity of R&D in pharmaceutical firms, accounting-based profit metrics in the drug sector may be affected to a greater extent than other industries. The aim of this work was to address measurement issues associated with corporate performance and factors that contribute to the bias within accounting-based rates of return. Seminal and broadly cited works on the subject of accounting- versus economic-based rates of return were reviewed from the economic and finance literature, with an emphasis placed on issues and scientific evidence directly related to the drug development process and pharmaceutical industry. With international convergence and harmonization of accounting standards being imminent, stricter adherence to theoretically sound economic principles is advocated, particularly those based on discounted cash-flow methods. Researchers, financial analysts, and policy makers must be cognizant of the biases and limitations present within numerous corporate performance measures. Furthermore, the development of more robust and valid economic models of the pharmaceutical industry is required to capture the unique dimensions of risk and return of the drug development process. Empiric work has illustrated that estimates of economic-based rates of return range from approximately 2 to approximately 11 percentage points below various accounting-based rates of return for drug companies. Because differences in the nature of risk and uncertainty borne by drug manufacturers versus other sectors make comparative assessments

Nanotechnology tools in pharmaceutical R&D

OpenAIRE

Challa S.S.R. Kumar

2010-01-01

Nanotechnology is a new approach to problem solving and can be considered as a collection of tools and ideas which can be applied in pharmaceutical industry. Application of nanotechnology tools in pharmaceutical R&D is likely to result in moving the industry from ‘blockbuster drug’ model to ‘personalized medicine’. There are compelling applications in pharmaceutical industry where inexpensive nanotechnology tools can be utilized. The review explores the possibility of categorizing various nan...

Aspects of Global Health Issues: Diseases, Natural Disasters, and Pharmaceutical Corporations and Medical Research.

Science.gov (United States)

Brown, Geraldine

2016-01-01

Global health issues are concerns of all public health officials throughout the world. This entails reviewing aspects such as the impact of poverty and the lack of access to quality health care, ignored global killers such as Diseases (Infectious diseases-Malaria, HIV/AIDS), Natural Disasters (Earthquakes, Tsunamis, Floods, and Armed Conflict), Health in the Media, and the Involvement of Pharmaceutical Corporations and Medical Research. These issues are challenges to many needless deaths. Global initiatives are not advancing as they should, such as access to drugs and medications, which some are political.

EVOLUTIONS IN GLOBAL AUTOMOBILES INDUSTRY

Directory of Open Access Journals (Sweden)

Viorel Pop

2013-09-01

Full Text Available This paper is a brief overview of the evolution of the global automotive industry during the 20th century, with reference to the main manufacturers, oil crises of 1970-1980, and also the global financial and economic crisis that began in 2008. The analyzed period covers the rise of the Asian Continent, beginning with Japan, then South Korea and more recently the emerging countries: China and India. What was predicted 20-25 years ago, became reality: Asia becomes the economic centre of the world, surpassing unexpectedly fast even the Euro-Atlantic area. Regarding Romania, the revival delay of the automobiles industry, led to the loss of the trucks and bus industry, and after a much awaited rehabilitation of car production, this has stuck now at an unsatisfactory level.

Global Operations at Aalborg Industries

DEFF Research Database (Denmark)

Wæhrens, Brian Vejrum; Slepniov, Dmitrij

2011-01-01

to successfully reconfigure its operations set-up to meet new contextual conditions. This case was prepared in 2009, through a number of interviews and managers from all business functions as well as top management. The authors do not intend to illustrate either effective or ineffective handling of a managerial......The aim of this case is to describe the development of Aalborg Industries into a global company. Aalborg Industries has been an example to many companies, as it has managed to maintain a leading market position in a highly competitive and increasingly globalized marked and has managed...

Impact analysis of the implemented quality management system on business performances in pharmaceutical-chemical industry in Serbia

Directory of Open Access Journals (Sweden)

Marinković Valentina D.

2013-01-01

Full Text Available International quality management standard (QMS ISO 9001 became widely accepted as a framework for product and/or services quality improvement. There are recent research conducted in order to define relationships and effects between the applied QMS and financial and/or non-financial business parameters. The effects of the applied pharmaceutical quality system (PQS on the business performances in Serbian pharmaceutical-chemical industry are analyzed in this paper using multivariate linear regression analysis. The empirical data were collected using a survey that was performed among experts from Serbian pharmaceutical-chemical industrial sector during 2010. An extensive questionnaire was used in the survey, grouping the questions in eight groups: Implementation of pharmaceutical quality system (AQ, Quality/strategy planning (QP, Human resource management (HR, Supply management (SM, Customer focus (CF, Process management (PM, Continuous improvement (CI, and Business results (BR. The primary goal of the research was to analyze the effects of the elements of first seven groups (AQ, QP, HR, SM, CF, PM, and CI that present various aspects of the implementation of PQS, on the elements of business results (BR. Based on empirical data, regression relations were formed to present the effects of all considered elements of PQS implementation on the business performance parameters (BR. The positive effects of PQS implementation on the business performances such as the assessment of performance indicators, continual products and/or services quality improvement, and efficient problem solving, are confirmed in the presented research for the Serbian pharmaceutical-chemical industrial sector. The results of the presented research will create a room for the improvement of the existing models in application, and for attracting interested parties that aim to commence this business standardization process. Hence, implementation of PQS is not only the regulatory

Pharmaceutical Company Corruption and the Moral Crisis in Medicine.

Science.gov (United States)

Batt, Sharon

2016-07-01

A much-debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics "pharmascolds." Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high-income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. © 2016 The Hastings Center.

Presentation of a Novel Model for Evaluation of Commercialization of Research and Development: Case Study of the Pharmaceutical Biotechnology Industry.

Science.gov (United States)

Emami, Hassan; Radfar, Reza

2017-01-01

The current situation in Iran suggests an appropriate basis for developing biotechnology industries, because the patents for the majority of hi-tech medicines registered in developed countries are ending. Biosimilar and technology-oriented companies which do not have patents will have the opportunity to enter the biosimilar market and move toward innovative initiatives. The present research proposed a model by which one can evaluate commercialization of achievements obtained from research with a focus on the pharmaceutical biotechnology industry. This is a descriptive-analytic study where mixed methodology is followed by a heuristic approach. The statistical population was pharmaceutical biotechnology experts at universities and research centers in Iran. Structural equations were employed in this research. The results indicate that there are three effective layers within commercialization in the proposed model. These are a general layer (factors associated with management, human capital, legal infrastructure, communication infrastructure, a technical and executive infrastructures, and financial factors), industrial layer (internal industrial factors and pharmaceutical industry factors), and a third layer that included national and international aspects. These layers comprise 6 domains, 21 indices, 41 dimensions, and 126 components. Compilation of these layers (general layer, industrial layer, and national and international aspects) can serve commercialization of research and development as an effective evaluation package.

An Estimation of the Potential Utilization in Iranian Pharmaceutical Industry Involved in the Stock Exchange, 2008-2012

Science.gov (United States)

Annabi, Majid; Kebriaeezadeh, Abbas; Mohammadi, Timor; Marashi Shoshtari, Seyed Nasrolah; Abedin Dorkoosh, Farid; Pourreza, Abolghasem; Heydari, Hassan

2017-01-01

The aim of this study was to measure the potential of production and the capacity used in the pharmaceutical industry. Capacity use is the actual production rate to the potential output, which reflects the gap between actual production and production capacity. Through econometric methods, translog cost function in the short run along with functions of share cost of production factors is estimated through seemingly unrelated repeated regression (SURE) as a multivariate regression analysis provided by zeller. During the study the capacity used is decreasing. The capacity used, which calculated by weighted average, also decreased and the amount during the study period is much less than the simple average of the industry. Average capacity utilization in the industry over five years of study is equal to 57% while the average capacity used calculated by the weighted of industry average is 37%. To enhance the economic potential requires a proper use of resources, creation of favorable economic structure and productivity of the industry. Due to the large amount of unused capacity in the pharmaceutical industry there is no need to invest anymore unless in new grounds and it is obvious that more investment will change using capacity. PMID:29552074

An Estimation of the Potential Utilization in Iranian Pharmaceutical Industry Involved in the Stock Exchange, 2008-2012.

Science.gov (United States)

Annabi, Majid; Kebriaeezadeh, Abbas; Mohammadi, Timor; Marashi Shoshtari, Seyed Nasrolah; Abedin Dorkoosh, Farid; Pourreza, Abolghasem; Heydari, Hassan

2017-01-01

The aim of this study was to measure the potential of production and the capacity used in the pharmaceutical industry. Capacity use is the actual production rate to the potential output, which reflects the gap between actual production and production capacity . Through econometric methods, translog cost function in the short run along with functions of share cost of production factors is estimated through seemingly unrelated repeated regression (SURE) as a multivariate regression analysis provided by zeller. During the study the capacity used is decreasing. The capacity used, which calculated by weighted average, also decreased and the amount during the study period is much less than the simple average of the industry. Average capacity utilization in the industry over five years of study is equal to 57% while the average capacity used calculated by the weighted of industry average is 37%. To enhance the economic potential requires a proper use of resources, creation of favorable economic structure and productivity of the industry. Due to the large amount of unused capacity in the pharmaceutical industry there is no need to invest anymore unless in new grounds and it is obvious that more investment will change using capacity.

Energy Efficiency Improvement and Cost Saving Opportunities for the Pharmaceutical Industry. An ENERGY STAR Guide for Energy and Plant Managers

Energy Technology Data Exchange (ETDEWEB)

Galitsky, Christina; Galitsky, Christina; Chang, Sheng-chieh; Worrell, Ernst; Masanet, Eric

2008-03-01

The U.S. pharmaceutical industry consumes almost $1 billion in energy annually. Energy efficiency improvement is an important way to reduce these costs and to increase predictable earnings, especially in times of high energy price volatility. There are a variety of opportunities available at individual plants in the U.S. pharmaceutical industry to reduce energy consumption in a cost-effective manner. This Energy Guide discusses energy efficiency practices and energy efficient technologies that can be implemented at the component, process, system, and organizational levels. A discussion of the trends, structure, and energy consumption characteristics of the U.S. pharmaceutical industry is provided along with a description of the major process steps in the pharmaceutical manufacturing process. Expected savings in energy and energy-related costs are given for many energy efficiency measures, based on case study data from real-world applications in pharmaceutical and related facilities worldwide. Typical measure payback periods and references to further information in the technical literature are also provided, when available. The information in this Energy Guide is intended to help energy and plant managers reduce energy consumption in a cost-effective manner while meeting regulatory requirements and maintaining the quality of products manufactured. At individual plants, further research on the economics of the measures?as well as their applicability to different production practices?is needed to assess potential implementation of selected technologies.

Publication Trend of Clinical Trials with Negative Results Funded by Pharmaceutical Industries for the 2007-2012 Period

Directory of Open Access Journals (Sweden)

Evert A. Jiménez-Cotes

2015-01-01

Full Text Available Abstract: Objective: To evaluate the results of clinical trials financed by the pharmaceutical industries during the period 2007-2012 in a general medical journal. Materials and methods: We performed an observational cross sectional study where originals clinical trials financed by the pharmaceutical industry published between 2007 and 2012 in the journal The New England Journal of Medicine (http://www.nejm.org were reviewed. Trend Chi2 test was used to evaluate the results of studies over the years. A database was created with different variables, identifying the number of publications and the period of greater publishing negatives studies, as well as the medical specialty and pharmaceutical industry funding. Results: 321 clinical trials were analyzed. The Odds Ratio was calculated for each year evaluated, finding a Chi2 of linear trend in negatives studies of 2.91 with value p 0.08 and positive studies of 1.16 with value p 0.28. It was found that in the period 2007-2009 123 studies were published, 40 % of which presented negative results; unlike the 2010-2012 period in which 198 clinical trials where published, 142 of them, showed positive results, OR 1.68, 95 % CI (1.02-2.78 value p 0.03. The highest figures of negative results were published in 2007: 44.7 %. Conclusions: A progressive decrease in the number of publications with annual general negative results has been observed. A statistically significant difference in the publication of negative studies per year was not found between the periods 2007-2012. The medical specialty that showed the largest number of total and negative publications in both periods was cardiology. The pharmaceutical industry that sponsored most total clinical trials with negative results in both periods did so through Merck, Glaxo SmithKline, and Sanofi-Aventis. 50% of neurology publications showed negative results.

A novel approach for inventory problem in the pharmaceutical supply chain.

Science.gov (United States)

Candan, Gökçe; Yazgan, Harun Reşit

2016-02-24

In pharmaceutical enterprises, keeping up with global market conditions is possible with properly selected supply chain management policies. Generally; demand-driven classical supply chain model is used in the pharmaceutical industry. In this study, a new mathematical model is developed to solve an inventory problem in the pharmaceutical supply chain. Unlike the studies in literature, the "shelf life and product transition times" constraints are considered, simultaneously, first time in the pharmaceutical production inventory problem. The problem is formulated as a mixed-integer linear programming (MILP) model with a hybrid time representation. The objective is to maximize total net profit. Effectiveness of the proposed model is illustrated considering a classical and a vendor managed inventory (VMI) supply chain on an experimental study. To show the effectiveness of the model, an experimental study is performed; which contains 2 different supply chain policy (Classical and VMI), 24 and 30 months planning horizon, 10 and 15 different cephalosporin products. Finally the mathematical model is compared to another model in literature and the results show that proposed model is superior. This study suggest a novel approach for solving pharmaceutical inventory problem. The developed model is maximizing total net profit while determining optimal production plan under shelf life and product transition constraints in the pharmaceutical industry. And we believe that the proposed model is much more closed to real life unlike the other studies in literature.

Globalisation of tobacco industry influence and new global responses

Science.gov (United States)

Yach, D.; Bettcher, D.

2000-01-01

The globalisation of tobacco marketing, trade, research, and industry influence represents a major threat to public health worldwide. Drawing upon tobacco industry strategy documents prepared over several decades, this paper will demonstrate how the tobacco industry operates as a global force, regarding the world as its operating market by planning, developing, and marketing its products on a global scale. The industry has used a wide range of methods to buy influence and power, and penetrate markets across the world. It has an annual turnover of almost US$400 billion. In contrast, until recently tobacco control lacked global leadership and strategic direction and had been severely underfunded. As part of moving towards a more sustainable form of globalisation, a global enabling environment linked to local actions should focus on the following strategies: global information management; development of nationally and locally grounded action; global regulation, legal instruments, and foreign policy; and establishment of strong partnerships with purpose. As the vector of the tobacco epidemic, the tobacco industry's actions fall far outside of the boundaries of global corporate responsibility. Therefore, global and local actions should not provide the tobacco industry with the two things that it needs to ensure its long term profitability: respectability and predictability.


Keywords: globalisation of tobacco marketing PMID:10841858

Characterization of the medical department of pharmaceutical companies operating in Portugal

Directory of Open Access Journals (Sweden)

Acílio Gala

2017-04-01

Full Text Available In a context of strong regulatory demands and high economic pressures and constraints, medical departments within pharmaceutical companies, have demonstrated its strategic relevance even though the functions to embrace are not globally consensual. In this context, a study that intended to analyse the management of medical activities, in pharmaceutical companies operating in Portugal, including allocated human resources and investment trends, was implemented. Quantitative information was collected through an electronic survey, in pharmaceutical companies with activity in Portugal. The analysis of the results supported the conclusion that the majority of the companies are affiliates of international companies and that 79% of them have formalized medical departments. The human resources of the medical departments of the participant companies include several professional classes, with predominance of pharmacists. Globally, the number of employees of the medical area has registered a systematic growth in the last years. It was also possible to conclude that the majority of the companies are increasing the investment in medical affairs activities. This study enables the understanding of these activities in pharmaceutical companies operating in Portugal, within the international panorama of pharmaceutical industry. It contributes to improve the knowledge about the relevance of medical departments while enabling the definition of novel pathways to increase the competiveness and sustainability of the companies.

Macro-economic factors influencing the architectural business model shift in the pharmaceutical industry.

Science.gov (United States)

Dierks, Raphaela Marie Louisa; Bruyère, Olivier; Reginster, Jean-Yves; Richy, Florent-Frederic

2016-10-01

Technological innovations, new regulations, increasing costs of drug productions and new demands are only few key drivers of a projected alternation in the pharmaceutical industry. The purpose of this review is to understand the macro economic factors responsible for the business model revolution to possess a competitive advantage over market players. Areas covered: Existing literature on macro-economic factors changing the pharmaceutical landscape has been reviewed to present a clear image of the current market environment. Expert commentary: Literature shows that pharmaceutical companies are facing an architectural alteration, however the evidence on the rationale driving the transformation is outstanding. Merger & Acquisitions (M&A) deals and collaborations are headlining the papers. Q1 2016 did show a major slowdown in M&A deals by volume since 2013 (with deal cancellations of Pfizer and Allergan, or the downfall of Valeant), but pharmaceutical analysts remain confident that this shortfall was a consequence of the equity market volatility. It seems likely that the shift to an M&A model will become apparent during the remainder of 2016, with deal announcements of Abbott Laboratories, AbbVie and Sanofi worth USD 45billion showing the appetite of big pharma companies to shift from the fully vertical integrated business model to more horizontal business models.

The role of the pharmaceutical animal health industry in post-marketing surveillance of resistance.

Science.gov (United States)

Lens, S

1993-06-01

The pharmaceutical animal health industry must be committed to the total life cycle of products, i.e. during both the pre- and post-marketing period. Support of antibacterial agents during the postmarketing period is not restricted to maintaining a well-established distribution and promotion system. Care has to be taken continuously to maintain and/or improve the quality, safety (for user, target animal and environment) and clinical efficacy. The pharmaceutical industry contributes to this by: 1. Introducing antibacterials in different animal species for the most effective disease condition only and by ensuring the veterinary profession is informed about relevant findings on: a. the mechanism of action; b. pharmacodynamic properties; c. pharmacokinetic properties (plasma, target tissue); d. clinical efficacy data and in vitro sensitivity data; e. valid species-specific MIC breakpoints; f. precise dose and treatment regime. 2. Updating on a regular basis on: a. new findings on the mechanism of action (in vitro and in vivo); b. the optimal use program in the light of changes in animal husbandry, farm management and epidemiology on national and international level; c. adjustment of species-specific MIC breakpoints when necessary. 3. Providing continuous information in collaboration with animal health laboratories about: a. clinical field surveillance for efficacy (national, international); b. in vitro sensitivity/resistance surveillance (national, international); c. use of in vitro data to support prediction of in vivo efficacy. Surveillance of resistance, in vitro, is therefore part of a package of information needed on a routine basis by the pharmaceutical industry to allow the best possible use of antibacterials and to minimize induction of resistance.(ABSTRACT TRUNCATED AT 250 WORDS)

Assessing global resource utilization efficiency in the industrial sector

International Nuclear Information System (INIS)

Rosen, Marc A.

2013-01-01

Designing efficient energy systems, which also meet economic, environmental and other objectives and constraints, is a significant challenge. In a world with finite natural resources and large energy demands, it is important to understand not just actual efficiencies, but also limits to efficiency, as the latter identify margins for efficiency improvement. Energy analysis alone is inadequate, e.g., it yields energy efficiencies that do not provide limits to efficiency. To obtain meaningful and useful efficiencies for energy systems, and to clarify losses, exergy analysis is a beneficial and useful tool. Here, the global industrial sector and industries within it are assessed by using energy and exergy methods. The objective is to improve the understanding of the efficiency of global resource use in the industrial sector and, with this information, to facilitate the development, prioritization and ultimate implementation of rational improvement options. Global energy and exergy flow diagrams for the industrial sector are developed and overall efficiencies for the global industrial sector evaluated as 51% based on energy and 30% based on exergy. Consequently, exergy analysis indicates a less efficient picture of energy use in the global industrial sector than does energy analysis. A larger margin for improvement exists from an exergy perspective, compared to the overly optimistic margin indicated by energy. - Highlights: ► The global industrial sector and its industries are assessed by using energy and exergy methods. ► Global industrial sector efficiencies are evaluated as 51% based on energy and 30% based on exergy. ► Exergy analysis shows global industrial energy to be less efficient than does energy analysis. ► A misleadingly low margin for efficiency improvement is indicated by energy analysis. ► A significant and rational margin for efficiency improvement exists from an exergy perspective

The importance of social networks on the origins of argentinian pharmaceutical industry. The case of Catalans

OpenAIRE

Campins, Mónica; Pfeiffer, Ana

2017-01-01

This article aims to give a broader interpretation of the development of science-based industries in latecomer countries like Argentina. The approach used in the research work is supported by contributions from Nuria Puig on the role of social networks in the pharmaceutical industry development in late industrializing countries and reinforces the idea of Franco Ramella about the importance of a strong use of network concept. Historical research shows that social networks of the Catalan commun...

Factors associated with the burnout syndrome among professionals in pharmaceutical manufacturing industry and marketing 1234

Directory of Open Access Journals (Sweden)

Jovanović Vesna R.

2017-01-01

Full Text Available Certain authors describe some professions in the healthcare industry as the more susceptible ones to developing a burnout syndrome, while others suggest psychosocial aspects of the workplace as the primary cause in its creation, but not the aspects of the job itself. The main objective of the research was to investigate which specific factors were associated with the burnout syndrome among professionals working in pharmaceutical manufacturing industry and marketing. The study was conducted in June of 2016 as a cross-sectional study and it included 75 university educated professionals from the area of pharmaceutical industry and marketing employed in several local as well as internationally renowned pharmaceutical companies located in Belgrade. The participants were surveyed anonymously. The instruments used in the study were: a general socio-demographic questionnaire, an assertiveness self-evaluation questionnaire and the Maslach Burnout Inventory. An analysis of the responses in the burnout syndrome self-evaluation questionnaires showed that the highest level of burnout was expressed through reduced personal accomplishment (53%. The average assertiveness scores were the lowest in the individuals who demonstrated the highest level of emotional exhaustion (p=0.003, depersonalization (p=0.004, and the highest inefficiency on professional accomplishment scale (p=0.001. A statistically significant difference was observed in frequency and extent of emotional exhaustion with respect to respondents' gender (x2=10.779; p<0.05, as well as the line of business (x2=6.493; p<0.05. Levels of depersonalization are influenced by: line of work (x2=5.393; p<0.05, age (p=0.004, total years of service (p=0.009 and years of service in the profession (p=0.006. A sense of reduced personal accomplishment is influenced by a respondents' profession (x2=10.922; p<0.05 and line of business (x2=7.283; p<0.05. The results obtained in this study might help in identifying

Situation analysis of R & d activities: an empirical study in Iranian pharmaceutical companies.

Science.gov (United States)

Rasekh, Hamid Reza; Mehralian, Gholamhossein; Vatankhah-Mohammadabadi, Abbas Ali

2012-01-01

As global competition intensifies, research and development (R & D) organizations need to enhance their strategic management in order to become goal-directed communities for innovation and allocate their resources consistent with their overall R & D strategy. The world pharmaceutical market has undergone fast, unprecedented, tremendous and complex changes in the last several years. The pharmaceutical industry is today still one of the most inventive, innovative and lucrative of the so-called "high-tech" industries. This industry serves a dual role in modern society. On one hand, it is a growing industry, and its output makes a direct contribution to gross domestic product (GDP). On the other side, drugs, this industry's major output, are an input in the production of good health. The purpose of this study is to evaluate R & D activities of pharmaceutical companies, and also to highlight critical factors which have influential effect on results of these activities. To run this study a valid questionnaire based on literature review and experts' opinion was designed and delivered to 11 pharmaceutical companies. Empirical data show there is not acceptable situations considering of the factors that should be taken in to account by managers including; management commitment, human resource management, information technology and financial management. Furthermore, we concluded some interesting results related to different aspects of R & D management. In conclusion, managers must be aware about their performance in R & D activities, accordingly they will able to take a comprehensive policy in both national and within the company.

R&D INTENSITY AND IPO UNDERPRICING: CASE STUDY ON PHARMACEUTICAL AND BIOTECH INDUSTRIES IN THE US

Directory of Open Access Journals (Sweden)

Tommy C. Efrata

2016-02-01

Full Text Available Asymmetric information between the issuer to potential investors believed by some academics in finance as one of the main causes of the phenomenon of underpricing at the time of the initial public offering (IPO. On science and technology-based company main problem lies in how to conduct assessments on the future value of a product that is still in the development stage. The issue became more prominent on pharmaceutical companies and biotechnology, due to the characteristics of this industry is the high expense, complex process, and the lengthy process of research and development (R & D of a product. This study describes the characteristics above is associated with the phenomenon of underpricing when companies conduct IPO. The samples are 82 pharmaceutical companies and biotechnology conduct IPO in the United States stock market in 1998-2005. The results of this study revealed a negative correlation between the intensity of R & D and IPO underpricing phenomenon in this industry. These studies have identified R & D as the main source of information asymmetry that led to the phenomenon of underpricing for pharmaceutical companies and biotechnology.

Strategic of Applying Free Chemical Usage In Purified Water System For Pharmaceutical Industry Toward CPOB (Cara Pembuatan Obat yang Baik Indonesia To Reducing Environmental Pollution

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Kartono R.

2014-03-01

Full Text Available The purpose of this paper is to examine the sets of model and literature review to prove that strategy of applying free chemical usage in purified water system for pharmaceutical industry would be help the existing and new pharmaceutical companies to comply with part of Natioanal Agency of Drug and Food Control / Badan Pengawas Obat dan Makanan (NADFC/BPOM regulation in order to achieve “Cara Pembuatan Obat yang Baik” (CPOB of Indonesia pharmaceutical industry. One of the main reasons is when we figured out the number of Indonesian pharmaceutical industries in 2012 are kept reducing compare to the increasing numbers of Indonesian population growth. This strategy concept also might help the industries to reducing environmental pollution, and operational cost in pharmaceutical industries, by reducing of the chemical usage for water treatment process in floculation and cougulation and chlorination for sterillization. This new model is free usage of chemicals for purified water generation system process and sterilization. The concept offering of using membrane technology- Reverse Osmosis (RO membrane base treatment to replace traditional chemical base treatment, following enhance Electrodeionization (EDI as final polisher for controlling conductivity, and finally Ultra Violet (UV disinfectant technology as final guard for bacteria controls instead of chemical base system in purified water generation system.

Strategic of Applying Free Chemical Usage In Purified Water System For Pharmaceutical Industry Toward CPOB (Cara Pembuatan Obat yang Baik) Indonesia To Reducing Environmental Pollution

Science.gov (United States)

Kartono, R.; Basuki, Y. T.

2014-03-01

The purpose of this paper is to examine the sets of model and literature review to prove that strategy of applying free chemical usage in purified water system for pharmaceutical industry would be help the existing and new pharmaceutical companies to comply with part of Natioanal Agency of Drug and Food Control / Badan Pengawas Obat dan Makanan (NADFC/BPOM) regulation in order to achieve "Cara Pembuatan Obat yang Baik" (CPOB) of Indonesia pharmaceutical industry. One of the main reasons is when we figured out the number of Indonesian pharmaceutical industries in 2012 are kept reducing compare to the increasing numbers of Indonesian population growth. This strategy concept also might help the industries to reducing environmental pollution, and operational cost in pharmaceutical industries, by reducing of the chemical usage for water treatment process in floculation and cougulation and chlorination for sterillization. This new model is free usage of chemicals for purified water generation system process and sterilization. The concept offering of using membrane technology- Reverse Osmosis (RO) membrane base treatment to replace traditional chemical base treatment, following enhance Electrodeionization (EDI) as final polisher for controlling conductivity, and finally Ultra Violet (UV) disinfectant technology as final guard for bacteria controls instead of chemical base system in purified water generation system.

A Method to Identify Best Available Technologies (BAT) for Hydrogenation Reactors in the Pharmaceutical Industry

Czech Academy of Sciences Publication Activity Database

Le Doan, T.V.; Stavárek, Petr; de Bellefon, C.

2012-01-01

Roč. 2, č. 3 (2012), s. 77-82 ISSN 2062-249X Grant - others:IMPULSE(XE) FP6-NMP2-CT-2005-011816 Institutional support: RVO:67985858 Keywords : hydrogenation * pharmaceuticals * methodology Subject RIV: CI - Industrial Chemistry, Chemical Engineering Impact factor: 4.091, year: 2012

Does growing up with a physician influence the ethics of medical students' relationships with the pharmaceutical industry? The cases of the US and Poland.

Science.gov (United States)

Makowska, Marta

2017-08-10

Medical schools have a major impact on future doctors' ethics and their attitudes towards cooperation with the pharmaceutical industry. From childhood, medical students who are related to a physician are exposed to the characteristics of a medical career and learn its professional ethics not only in school but also in the family setting. The present paper sought to answer the research question: 'How does growing up with a physician influence medical students' perceptions of conflicts of interest in their relationships with industry?' An anonymous questionnaire was completed by 451 medical students from four Philadelphia medical schools and 554 medical students from Warsaw Medical University during 2013. Medical schools in these two cities were chosen because they are both university cities with similar population sizes. Students who had and who did not have a family member working as a physician were compared using chi-square analysis. Data were analysed for each country separately. For both the US and Poland, there were statistically significant differences (p < .05) between medical students with a physician as a family member and other students with respect to views regarding relationship with the pharmaceutical industry. In both groups, this difference occurred for three important dimensions: students' relationship with the pharmaceutical industry; students' views on physicians' rights to cooperate with the pharmaceutical industry; trust in the pharmaceutical industry. In the US, students related to a doctor were characterized by more restrictive opinions on all three dimensions than other students (e.g., 27.8% of the former students vs. 31.4% of the latter students thought doctors had unrestricted rights to cooperate with the industry). However, the contrary was observed in Poland: students with a physician in the family had less strict views than their colleagues (e.g., 56.8% of the former vs. 39.7% of the latter thought that doctors should have unrestricted

Tropical Journal of Pharmaceutical Research

African Journals Online (AJOL)

Journal Homepage Image. We seek to encourage pharmaceutical and allied research of tropical and international relevance and to foster multidisciplinary research and collaboration among scientists, the pharmaceutical industry and the healthcare professionals. We publish articles in pharmaceutical sciences and related ...

The Rhetorical Helix of the Biotechnology and Pharmaceutical Industries: Strategies of Transformation through Definition, Description and Ingratiation

Science.gov (United States)

Gretton, Linda Burak

2009-01-01

The current pharmaceutical industry, whose origins date from the early 20th century, and the biotechnology industry, which emerged in the 1980s both have foundations built on the modern scientific method and share a mission to develop new drugs for humans and animals. At the same time, they are also made distinct by size (small biotechs versus…

The exploitation of "sicko-chatting" by the pharmaceutical industry : a strategy for the normalization of drug use

OpenAIRE

Niquette , Manon

2012-01-01

International audience; The Exploitation of 'sicko-chatting' by the Pharmaceutical industry: a strategy for the Normalization of drug use Pharmaceutical drugs are consumer goods. As such, they inscribe the transition from normality to pathology within the ambit of health marketing (Duclos, 2008, p. 109). It is now widely acknowledged that this pathology is not just a mere quantitative modification of the normal state, but that it also implies the patient's qualitative assessment of his or her...

Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry

CERN Document Server

Burdick, Richard K; Pfahler, Lori B; Quiroz, Jorge; Sidor, Leslie; Vukovinsky, Kimberly; Zhang, Lanju

2017-01-01

This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recomm...

Late Globalization and Evolution and Metamorphoses of Industries

DEFF Research Database (Denmark)

Boujarzadeh, Behnam; Turcan, Romeo V.; Dholakia, Nikhilesh

2016-01-01

In this paper we explore the effect of late globalization on evolution of industries. Specifically we investigate the impact of late globalization on the evolution and metamorphoses of Danish Textile and Fashion Industry (DTFI). Using historical data, we survey the development of DTFI between 1945...

Utilization of Lavandula angustifolia Miller extracts as naturalrepellents, pharmaceutical and industrial auxiliaries

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AYOE YUSUFOGLU

2004-01-01

Full Text Available Essential oils, absolutes and concretes were prepared from the flowers and leaves of the plant Lavandula angustifolia Miller cultivated in the Bosphorus region of Istanbul, Turkey. The difference in the chemical composition of the mentioned extracts was investigated and compared by using a combination of capillary GC-MS with the aim of offering them as repellent, pharmaceutical and industrial auxiliaries. The IR-spectra, the yields and the physico-chemical data of the extracts were also analysed.

Restoring a reputation: invoking the UNESCO Universal Declaration on Bioethics and Human Rights to bear on pharmaceutical pricing.

Science.gov (United States)

Hurst, Daniel J

2017-03-01

In public health, the issue of pharmaceutical pricing is a perennial problem. Recent high-profile examples, such as the September 2015 debacle involving Martin Shkreli and Turing Pharmaceuticals, are indicative of larger, systemic difficulties that plague the pharmaceutical industry in regards to drug pricing and the impact it yields on their reputation in the eyes of the public. For public health ethics, the issue of pharmaceutical pricing is rather crucial. Simply, individuals within a population require pharmaceuticals for disease prevention and management. In order to be effective, these pharmaceuticals must be accessibly priced. This analysis will explore the notion of corporate social responsibility in regards to pharmaceutical pricing with an aim of restoring a positive reputation upon the pharmaceutical industry in the public eye. The analysis will utilize the 2005 United Nations Educational, Scientific, and Cultural Organization's Universal Declaration on Bioethics and Human Rights (UDBHR) to establish implications regarding the societal responsibilities of pharmaceutical companies in a global context. To accomplish this, Article 14 of the UDBHR-social responsibility and health-will be articulated in order to advocate a viewpoint of socially responsible capitalism in which pharmaceutical companies continue as profit-making ventures, yet establish moral concern for the welfare of all their stakeholders, including the healthcare consumer.

Non clinical research at CENTIS supporting biotechnological and pharmaceutical industry

International Nuclear Information System (INIS)

Hernandez Gonzalez, Ignacio

2012-01-01

Drugs production is a highly demanding industry because the rigor of legislations and guidelines. Standards are applied to manufacturing facilities and also to research and development stage. Our national biotechnological industry is developing and producing important medications for diseases like cancer, some of them in the national and international market. Isotopes Centre is an institution supporting such development by means of a work platform to carry out researches in the field of pharmacokinetic and biodistribution in experimental models. Accumulated experience allows us to contribute to research and development of different kind of molecules as pharmaceuticals, specially the biotechnological ones. We are evolving in direction to new technologies and methodologies more suitable to current standards. Radiolabeling is still a convenient choice considering present and new imaging technologies to investigate distribution and kinetic in living subjects. With the techniques we have and the ones to incorporate in a near future, new and more demanding investigations will be affordable. (author)

How to revive breakthrough innovation in the pharmaceutical industry.

Science.gov (United States)

Munos, Bernard H; Chin, William W

2011-06-29

Over the past 20 years, pharmaceutical companies have implemented conservative management practices to improve the predictability of therapeutics discovery and success rates of drug candidates. This approach has often yielded compounds that are only marginally better than existing therapies, yet require larger, longer, and more complex trials. To fund them, companies have shifted resources away from drug discovery to late clinical development; this has hurt innovation and amplified the crisis brought by the expiration of patents on many best-selling drugs. Here, we argue that more breakthrough therapeutics will reach patients only if the industry ceases to pursue "safe" incremental innovation, re-engages in high-risk discovery research, and adopts collaborative innovation models that allow sharing of knowledge and costs among collaborators.

Creative Industries: Development Processes Under Contemporary Conditions of Globalization

Directory of Open Access Journals (Sweden)

Valerija Kontrimienė

2017-06-01

Full Text Available The article deals with the processes of developing creative industries under conditions of a growth in the worldwide economy and globalization, discloses the role of the sector of creative industries and shows its place in the system of the modern global economy. The paper presents a comparative analysis of theories and theoretical approaches intended for the sector of creative industries and its development as well as defines regularities and specificities characteristic of the development of creative industries. Particular attention is shifted on the growth and development of creative industries considering the current challenges of globalization and on the most important specificities of the developing sector in the context of the challenges of economic globalization. The paper examines the trends reflecting the place of the sector of creative industries in the economy of the modern world, including the tendencies indicating changes in the export of the products created in this sector. The article considers the issues of developing creative industries and reveals priorities of future research.

Pharmaceutical virtue.

Science.gov (United States)

Martin, Emily

2006-06-01

In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.

Pharmaceuticals occurrence in a WWTP with significant industrial contribution and its input into the river system

International Nuclear Information System (INIS)

Collado, N.; Rodriguez-Mozaz, S.; Gros, M.; Rubirola, A.; Barceló, D.; Comas, J.; Rodriguez-Roda, I.; Buttiglieri, G.

2014-01-01

Occurrence and removal of 81 representative Pharmaceutical Active Compounds (PhACs) were assessed in a municipal WWTP located in a highly industrialized area, with partial water reuse after UV tertiary treatment and discharge to a Mediterranean river. Water monitoring was performed in an integrated way at different points in the WWTP and river along three seasons. Consistent differences between therapeutic classes were observed in terms of influent concentration, removal efficiencies and seasonal variation. Conventional (primary and secondary) treatment was unable to completely remove numerous compounds and UV-based tertiary treatment played a complementary role for some of them. Industrial activity influence was highlighted in terms of PhACs presence and seasonal distribution. Even if global WWTP effluent impact on the studied river appeared to be minor, PhACs resulted widespread pollutants in river waters. Contamination can be particularly critical in summer in water scarcity areas, when water flow decreases considerably. -- Highlights: • Seasonal variation revealed a higher spring-summer removal compared to winter time. • Biological process was unable to provide a complete removal for most compounds. • UV-based tertiary treatment did play a complementary removal role for specific PhACs. • Diffuse river contamination and local WWTP contribution to it were observed. • River attenuation capacity is an important factor for removing most of the compounds. -- PhACs integrated WWTP-river data evaluation of coupled biological process and UV tertiary treatment in a WWTP with significant industrial contribution and in the receiving river waters

From maturity to value-added innovation: lessons from the pharmaceutical and agro-biotechnology industries.

Science.gov (United States)

Mittra, James; Tait, Joyce; Wield, David

2011-03-01

The pharmaceutical and agro-biotechnology industries have been confronted by dwindling product pipelines and rapid developments in life sciences, thus demanding a strategic rethink of conventional research and development. Despite offering both industries a solution to the pipeline problem, the life sciences have also brought complex regulatory challenges for firms. In this paper, we comment on the response of these industries to the life science trajectory, in the context of maturing conventional small-molecule product pipelines and routes to market. The challenges of managing transition from maturity to new high-value-added innovation models are addressed. Furthermore, we argue that regulation plays a crucial role in shaping the innovation systems of both industries, and as such, we suggest potentially useful changes to the current regulatory system. Copyright © 2010 Elsevier Ltd. All rights reserved.

“Does Organizational Culture Influence the Ethical Behavior in the Pharmaceutical Industry?”

OpenAIRE

Nagashekhara, Molugulu; Agil, Syed Omar Syed

2012-01-01

Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured question...

Entrepreneurial patent management in pharmaceutical startups.

Science.gov (United States)

Holgersson, Marcus; Phan, Tai; Hedner, Thomas

2016-07-01

Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. Copyright © 2016 Elsevier Ltd. All rights reserved.

Achieving Carbon Neutrality in the Global Aluminum Industry

Science.gov (United States)

Das, Subodh

2012-02-01

In the 21st century, sustainability is widely regarded as the new corporate culture, and leading manufacturing companies (Toyota, GE, and Alcoa) and service companies (Google and Federal Express) are striving towards carbon neutrality. The current carbon footprint of the global aluminum industry is estimated at 500 million metric tonnes carbon dioxide equivalent (CO2eq), representing about 1.7% of global emissions from all sources. For the global aluminum industry, carbon neutrality is defined as a state where the total "in-use" CO2eq saved from all products in current use, including incremental process efficiency improvements, recycling, and urban mining activities, equals the CO2eq expended to produce the global output of aluminum. This paper outlines an integrated and quantifiable plan for achieving "carbon neutrality" in the global aluminum industry by advocating five actionable steps: (1) increase use of "green" electrical energy grid by 8%, (2) reduce process energy needs by 16%, (3) deploy 35% of products in "in-use" energy saving applications, (4) divert 6.1 million metric tonnes/year from landfills, and (5) mine 4.5 million metric tonnes/year from aluminum-rich "urban mines." Since it takes 20 times more energy to make aluminum from bauxite ore than to recycle it from scrap, the global aluminum industry could set a reasonable, self-imposed energy/carbon neutrality goal to incrementally increase the supply of recycled aluminum by at least 1.05 metric tonnes for every tonne of incremental production via primary aluminum smelter capacity. Furthermore, the aluminum industry can and should take a global leadership position by actively developing internationally accepted and approved carbon footprint credit protocols.

Recent Regulatory Trends in Pharmaceutical Manufacturing and their Impact on the Industry.

Science.gov (United States)

Tabersky, Daniel; Woelfle, Michael; Ruess, Juan-Antonio; Brem, Simon; Brombacher, Stephan

2018-03-30

The pharmaceutical industry is one of the most regulated industries in Switzerland. Though the concept of good manufacturing practises (GMP) was implemented for chemical production in the early 1990s, the rules and regulations for our industry are in constant evolution. In this article we will highlight the impact of these changes to the industry using three recent guideline up-dates as examples: the implementation of ICH Q3D 'Guideline for elemental impurities', the EU-GMP Guideline Part III Chapter 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities' from 01. June 2015, and the new guidelines to data integrity such as 'PIC/S 041-1 Good Practices for Data Management and Integrity in regulated GMP/GDP environments'. These examples show how scientific approaches help to modernize the control strategies for our products and increase product quality for a better patient safety. The requirements of data integrity regulations are also of interest to industries and universities not working under GxP requirements as they also support the business to improve data quality (traceability) for patent applications, and reduce risk of data falsification.

Proposed changes to the reimbursement of pharmaceuticals and medical devices in Poland and their impact on market access and the pharmaceutical industry

Science.gov (United States)

Badora, Karolina; Caban, Aleksandra; Rémuzat, Cécile; Dussart, Claude; Toumi, Mondher

2017-01-01

ABSTRACT In Poland, two proposed amendments to the reimbursement act are currently in preparation; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Proposed changes include: alignment of medical device reimbursement with that of pharmaceuticals; relaxing the strict reimbursement criteria for ultra-orphan drugs; establishment of an additional funding category for vaccines; introduction of compassionate use, and a simplified reimbursement pathway for well-established off-label indications; appreciation of manufacturers’ innovation and research and development efforts by creating a dedicated innovation budget; introduction of a mechanism preventing excessive parallel import; prolonged duration of reimbursement decisions and reimbursement lists; and increased flexibility in defining drug programmes. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry in Poland. PMID:29081924

Supply Chain Management in Zhendong Pharmaceutical Company

OpenAIRE

Li, Yan

2011-01-01

Medicines are special commodity related to people’s lives and health, therefore, pharmaceutical distribution is an industry affecting the national economy and the people's livelihood. With health care reform, changeable pharmaceutical policy and fiercely increasing competition in the medical industry, pharmaceutical distribution companies should improve their level of logistics operations and reduce overall logistics management costs in order to gain a leading position in the competition. In ...

Investigating the turnover of middle and senior managers in the pharmaceutical industry in South Africa

Directory of Open Access Journals (Sweden)

Abofele Khoele

2014-08-01

Full Text Available Orientation: Today, knowledge is a commodity and thus skilled knowledge workers, particularly in management positions, are vital for organisations’ success; their increased turnover has an adverse effect on productivity and profitability. High staff turnover is a cause for alarm, not only because of the costs associated with recruitment, selection and training, but also due to the increasing scarcity of experienced talent. Research purpose: This research investigates the reasons for the turnover of middle and senior managers in the pharmaceutical industry in South Africa in order to identify the possible reasons and formulate solutions to address the issue. Motivation for the study: In South Africa, employment, retention and turnover occur against the backdrop of a history of discrimination and inequality and attempts by government and organisations at redress. The significance of this background cannot be underestimated. Research approach, design and method: This study was qualitative and inductive to allow dominant themes to emerge from the raw data. Data was collected through in-depth, semi-structured one-on-one interviews as well as a review of company turnover reports and employment equity reports. Main findings: The study found that in the sampled organisations, employee turnover averaged almost 22% per annum between 2007 and 2010. Reasons for the turnover include a range of industry, company and personal factors. Practical/managerial implications: The overall turnover rate remains high, particularly amongst black knowledge workers, the attraction, recruitment and retention of whom is as important for addressing historical inequities in the local industry as it is for ensuring the diversity that companies need to reach a bigger market and gain a competitive edge. Further, as government is a significant purchaser of pharmaceutical goods and services, companies must ensure that the required Black Economic Empowerment (BEE rating level is

Assessment of Food Processing and Pharmaceutical Industrial Wastes as Potential Biosorbents: A Review

OpenAIRE

El-Sayed, Hanan E. M.; El-Sayed, Mayyada M. H.

2014-01-01

There is a growing need for the use of low-cost and ecofriendly adsorbents in water/wastewater treatment applications. Conventional adsorbents as well as biosorbents from different natural and agricultural sources have been extensively studied and reviewed. However, there is a lack of reviews on biosorption utilizing industrial wastes, particularly those of food processing and pharmaceuticals. The current review evaluates the potential of these wastes as biosorbents for the removal of some ha...

Present Global Situation of Amino Acids in Industry.

Science.gov (United States)

Tonouchi, Naoto; Ito, Hisao

At present, amino acids are widely produced and utilized industrially. Initially, monosodium glutamate (MSG) was produced by extraction from a gluten hydrolysate. The amino acid industry started using the residual of the lysate. The discovery of the functions of amino acids has led to the expansion of their field of use. In addition to seasoning and other food use, amino acids are used in many fields such as animal nutrients, pharmaceuticals, and cosmetics. On the other hand, the invention of the glutamate fermentation process, followed by the development of fermentation methods for many other amino acids, is no less important. The supply of these amino acids at a low price is very essential for their industrial use. Most amino acids are now produced by fermentation. The consumption of many amino acids such as MSG or feed-use amino acids is still rapidly increasing.

PHARMACEUTICAL COMPANIES BETWEEN CRISIS AND COMPETITIVENESS - SECTORAL DIAGNOSIS

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Mihaela\tBÎRSAN

2015-06-01

Full Text Available The evolution of the pharmaceutical industry was a positive constant with the indicators of industrial production even in years of crisis. Although the economic crisis in Romania decreased average growth rate of pharmaceutical companies, market value is expected to increase. The explanation comes from the fact that in order to boost productivity, pharmaceutical companies are turning to emerging countries with aging populations such as open new markets for future development. Add to this the recent health policies implemented by newly industrialized countries that are aimed at ensuring increased access to care. Analysts see the field phenomenon called "Farma-merger" a good chance for European pharmaceutical companies oriented to developing countries where drug sales should record a double-digit annual growth until 2017. In Erste Group reports stated that the impact of the crisis on the pharmaceutical industry should be limited markets for EU only their economic slowdown. This will be possible because the external indebtedness of pharmaceutical companies in the EU remains at a minimum, they are able to finance their investment plans without tapping financial markets, are not adversely affected by the current limited availability of credit resources. Therefore major pharmaceutical companies in the EU will remain a solid investment on the long term, the negative developments are limited due to high resistance to the crisis their business model segment "generic". The consequence of these developments is reflected in the recognition for the first time, the pharmaceutical sector as a strategic sector for the Romanian economy. In the context of public debate launching the National Strategy for Competitiveness 2014-2020, Generic Medicines Industry Association of Romania (APMGR local pharmaceutical industry reminds the Government proposals on correcting the current fiscal and operational regulatory framework, to allow unlocking investments in facilities

Biocatalytic Synthesis of Chiral Pharmaceutical Intermediates

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Ramesh N. Patel

2004-01-01

Full Text Available The production of single enantiomers of drug intermediates has become increasingly important in the pharmaceutical industry. Chiral intermediates and fine chemicals are in high demand from both the pharmaceutical and agrochemical industries for the preparation of bulk drug substances and agricultural products. The enormous potential of microorganisms and enzymes for the transformation of synthetic chemicals with high chemo-, regio- and enantioselectivities has been demonstrated. In this article, biocatalytic processes are described for the synthesis of chiral pharmaceutical intermediates.

Why regulatory indifference towards pharmaceutical pollution of the environment could be a missed opportunity in public health protection. a holistic view.

Science.gov (United States)

Kamba, Pakoyo Fadhiru; Kaggwa, Bruhan; Munanura, Edson Ireeta; Okurut, Tom; Kitutu, Freddy Eric

2017-01-01

The last generation has witnessed bludgeoning of the world's population, a spike in disease burden, and unprecedented levels of pharmaceutical consumption and production. Unfortunately, pharmaceuticals have left their industrial and household confines and leaked into the environment. Pharmaceuticals are now major environmental pollutants, and are ubiquitous in waters and soils. Unlike other environmental contaminants, pharmaceutical pollutants are not yet regulated globally, simply because acute risk assessments show insignificant human health hazard. But the pitfalls of pharmaceutical pollutants extend beyond acute effects to delayed effects from bioaccumulation, amplified effects from drug-drug interactions, exacerbation of drug resistance, and reduction in aquatic and terrestrial food production. Therefore, ignoring pharmaceutical pollutants deprives society of holistic public health protection.

Assessing global resource utilization efficiency in the industrial sector.

Science.gov (United States)

Rosen, Marc A

2013-09-01

Designing efficient energy systems, which also meet economic, environmental and other objectives and constraints, is a significant challenge. In a world with finite natural resources and large energy demands, it is important to understand not just actual efficiencies, but also limits to efficiency, as the latter identify margins for efficiency improvement. Energy analysis alone is inadequate, e.g., it yields energy efficiencies that do not provide limits to efficiency. To obtain meaningful and useful efficiencies for energy systems, and to clarify losses, exergy analysis is a beneficial and useful tool. Here, the global industrial sector and industries within it are assessed by using energy and exergy methods. The objective is to improve the understanding of the efficiency of global resource use in the industrial sector and, with this information, to facilitate the development, prioritization and ultimate implementation of rational improvement options. Global energy and exergy flow diagrams for the industrial sector are developed and overall efficiencies for the global industrial sector evaluated as 51% based on energy and 30% based on exergy. Consequently, exergy analysis indicates a less efficient picture of energy use in the global industrial sector than does energy analysis. A larger margin for improvement exists from an exergy perspective, compared to the overly optimistic margin indicated by energy. Copyright © 2012 Elsevier B.V. All rights reserved.

Financing pharmaceuticals in transition economies.

Science.gov (United States)

Kanavos, P

1999-06-01

This paper (a) provides a methodological taxonomy of pricing, financing, reimbursement, and cost containment methodologies for pharmaceuticals; (b) analyzes complex agency relationships and the health versus industrial policy tradeoff; (c) pinpoints financing measures to balance safety and effectiveness of medicines and their affordability by publicly funded systems in transition; and (d) highlights viable options for policy-makers for the financing of pharmaceuticals in transition. Three categories of measures and their implications for pharmaceutical policy cost containing are analyzed: supply-side measures, targeting manufacturers, proxy demand-side measures, targeting physicians and pharmacists, and demand-side measures, targeting patients. In pursuing supply side measures, we explore free pricing for pharmaceuticals, direct price controls, cost-plus and cost pricing, average pricing and international price comparisons, profit control, reference pricing, the introduction of a fourth hurdle, positive and negative lists, and other price control measures. The analysis of proxy-demand measures includes budgets for physicians, generic policies, practice guidelines, monitoring the authorizing behavior of physicians, and disease management schemes. Demand-side measures explore the effectiveness of patient co-payments, the impact of allowing products over-the-counter and health promotion programs. Global policies should operate simultaneously on the supply, the proxy demand, and the demand-side. Policy-making needs to have a continuous long-term planning. The importation of policies into transition economy may require extensive and expensive adaptation, and/or lead to sub-optimal policy outcomes.

FORMATION AND FURTHER DEVELOPMENT OF MODERN PROMOTION OF PHARMACEUTICAL PRODUCTS

Directory of Open Access Journals (Sweden)

Юрий Владимирович Тарасов

2014-02-01

Full Text Available The articles addresses key notions and elements of marketing of pharmaceutical companies. Key stages and particularities of formation of pharmaceutical marketing are considered. It is proved that in general pharmaceutical market is developing under general marketing rules, however while developing strategy of promotion of pharmaceutical products specific features of the industry must be taken into consideration. The authors describes specific features of modern pharmaceutical market, which must be considered while developing policy of promotion of pharmaceutical products.The analysis is made of modern state of Russian pharmaceutical industry, its place in world pharmaceutical market. It is found that development of pharmaceutical market is directly influenced by the reform of pharmaceutical industry initiated by the Government of our country in 2008. Characteristic of current stage of market development is more strict conditions in marketing sphere and promotion of drugs. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-2

Pharmaceutical policies in European countries in response to the global financial crisis.

Science.gov (United States)

Vogler, Sabine; Zimmermann, Nina; Leopold, Christine; de Joncheere, Kees

2011-12-01

The objective of this paper is to analyze which pharmaceutical policies European countries applied during the global financial crisis. We undertook a survey with officials from public authorities for pharmaceutical pricing and reimbursement of 33 European countries represented in the PPRI (Pharmaceutical Pricing and Reimbursement Information) network based on a questionnaire. The survey was launched in September 2010 and repeated in February 2011 to obtain updated information. During the survey period from January 2010 to February 2011, 89 measures were identified in 23 of the 33 countries surveyed which were implemented to contain public medicines expenditure. Price reductions, changes in the co-payments, in the VAT rates on medicines and in the distribution margins were among the most common measures. More than a dozen countries reported measures under discussion or planned, for the remaining year 2011 and beyond. The largest number of measures were implemented in Iceland, the Baltic states (Estonia, Latvia, Lithuania), Greece, Spain and Portugal, which were hit by the crisis at different times. Cost-containment has been an issue for high-income countries in Europe - no matter if hit by the crisis or not. In recent months, changes in pharmaceutical policies were reported from 23 European countries. Measures which can be implemented rather swiftly (e.g. price cuts, changes in co-payments and VAT rates on medicines) were among the most frequent measures. While the "crisis countries" (e.g. Baltic states, Greece, Spain) reacted with a bundle of measures, reforms in other countries (e.g. Poland, Germany) were not directly linked to the crisis, but also aimed at containing public spending. Since further reforms are under way, we recommend that the monitoring exercise is continued.

THE EFFECT OF TRAINING IN THE IMPROVEMENT OF EMPLOYEE EFFICIENCY IN PHARMACEUTICAL INDUSTRY AND AN APPLICATION

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Sinem AYDOĞDU

2013-01-01

Full Text Available Businesses faces with important and rapid changes. This rapid change in the business environment forces the organizations to change their operations and structures. Adopting these changes fast and contionus renewal of both employees and organizations help organizations reach the set goals and survive in the competitive market. To be accomplished in competition, companies need well trained and well developed employees from front employees to the top level managers in the executive suite. Moreover, training process must gain continuity. Especially, in Pharmaceutical Industry, due to the fast and rapid changes and improvements concerning the regulations and procedures of Ministery of Health, guidelines such as GMP (Good Manufacturing Practises, GLP (Good Laboratory Practises, GDP (Good Documentation Practises etc. employees who are working should be trained and updated about the current knowledge to increase the efficiency in the organization. Vice versa, organizations can not raise their competition power in order to exist and develop themselves. To sum up, globalization, fast changes in regulations and procedures and also technological shifts lead to changes even in organizations. In order to cope with these changes, companies need to train their employees. The main purpose of this study is to investigate the effect of training on employee efficiency. Research is carried out with 74 employees from a pharmaceutical company in İstanbul, Turkey. The results of the study support the hypotheses. There’s a significant difference between white collar and blue collar employees on the idea of efficiency of training in the area of career development, area of productivity, professional growth and customer satisfaction.

The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school.

Science.gov (United States)

Stanley, A G; Jackson, D; Barnett, D B

2005-04-01

Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK.

Introduction: Institutional corruption and the pharmaceutical policy.

Science.gov (United States)

Rodwin, Marc A

2013-01-01

Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. © 2013 American Society of Law, Medicine & Ethics, Inc.

Lipases industrial applications: focus on food and agroindustries

Directory of Open Access Journals (Sweden)

Guerrand David

2017-07-01

Full Text Available Enzymes developed and produced for industrial applications represent a market estimated at a global value comprised between $5000 million and $5500 million in 2016. The major applications for industrial enzymes include food and beverages (dairy, bakery, fruit juices, beer, wine, detergents, biofuel productions, animal feed, and other applications such as textiles, leather, and paper processing. Altogether, food and feed applications account for 55–60% of the global enzymes market, and market is still growing at an estimated 6–8% annual growth. The lipases category represents less than 10% of the global enzymes market, with a broad range of industrial applications: detergents, oil processing, food processing and pharmaceutical end-users. Existing applications and new development in the food and agroindustries sectors are reviewed.

The emerging global energy industry

Energy Technology Data Exchange (ETDEWEB)

Churchill, A. [Washington International Energy Group, Washington, DC (United States)

1997-12-31

The global focus of the electric power industry was discussed. The shift from small regional monopolies to internationally competitive firms has been the driving force for change in industrial or market structures. The financial forces behind these changes were examined. The changes at the firm level and the implications of these changes for the North American market were explored. Changes in the North American market have influenced and are influenced by changes in international markets. The well established public and private monopolies in North America have been slow to welcome competition. However, with growing pressure from consumers, North America is becoming a major leader of global market trends. The following predictions regarding a deregulated electric power industry can be made with some confidence: (1) prices will fall, (2) customer choice will become a reality, (3) debt ridden public dinosaurs are not likely to survive, and (4) the same big firms in international markets will be the dominant players in the North American market. Canadian companies were warned that unless they can compete on equal terms with their American competitors, they may find themselves at a disadvantage in the new, competitive market.

The emerging global energy industry

Energy Technology Data Exchange (ETDEWEB)

Churchill, A [Washington International Energy Group, Washington, DC (United States)

1998-12-31

The global focus of the electric power industry was discussed. The shift from small regional monopolies to internationally competitive firms has been the driving force for change in industrial or market structures. The financial forces behind these changes were examined. The changes at the firm level and the implications of these changes for the North American market were explored. Changes in the North American market have influenced and are influenced by changes in international markets. The well established public and private monopolies in North America have been slow to welcome competition. However, with growing pressure from consumers, North America is becoming a major leader of global market trends. The following predictions regarding a deregulated electric power industry can be made with some confidence: (1) prices will fall, (2) customer choice will become a reality, (3) debt ridden public dinosaurs are not likely to survive, and (4) the same big firms in international markets will be the dominant players in the North American market. Canadian companies were warned that unless they can compete on equal terms with their American competitors, they may find themselves at a disadvantage in the new, competitive market.

The argument for pharmaceutical policy.

Science.gov (United States)

Traulsen, Janine Morgall; Almarsdóttir, Anna Birna

2005-02-01

Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.

Direct-to-consumer communication on prescription only medicines via the internet in the Netherlands, a pilot study. Opinion of the pharmaceutical industry, patient associations and support groups.

Science.gov (United States)

Fabius, A Mariette; Cheung, Ka-Chun; Rijcken, Cristianne J F; Vinkers, Christiaan H; Talsma, Herre

2004-06-01

Investigation of the current application of direct-to-consumer (DTC) communication on prescription only medicines via the Intemet in the Netherlands. Questionnaires were sent by e-mail to 43 Dutch innovative pharmaceutical industries and 130 Patient Association and Support Groups (PASGs). In this pilot study, the response of the pharmaceutical industry was rather low but the impression is that they were willing to invest in DTC communication. The majority of the websites of PASGs did not link to websites of pharmaceutical companies. The PASGs had no opinion whether patients can make a good distinction between DTC advertising and information on websites of the pharmaceutical industry nor about the quality. PASGs did not think unambiguously about the impact on the patient-doctor relationship. The impact of DTC communication on prescription only medicines via the internet is not yet clear in the Netherlands.

Pharmacoligaclly Active: Clinical Trials and the Pharmaceuticals ...

African Journals Online (AJOL)

Multinational pharmaceutical companies ('pharmas') import and produce pharmaceuticals and also conduct clinical trials which are an important aspect of research and development (R&D). This may raise the question: Is South Africa a guinea pig for the pharmas? The Department of Trade and Industry National Industrial ...

New applications to computerized tomography: analysis of solid dosage forms produced by pharmaceutical industry

International Nuclear Information System (INIS)

Oliveira Junior, Jose Martins de; Martins, Antonio Cesar Germano

2009-01-01

Full text: In recent years, computerized tomography (CT) has been used as a new probe to study solid dosage forms (tablets) produced by pharmaceutical industry. This new approach to study tablet and powder, or granulation, properties used in pharmaceutical industry is very suitable. First because CT can generate information that traditional technologies used in this kind of analysis can not, such as, density distribution of internal structures and tablet dimensions, pore size distribution, particle shape information, and also investigation of official and unofficial (counterfeit) copies of solid dosage forms. Second because CT is a nondestructive technique, allowing the use of tablets or granules in others analysis. In this work we discus how CT can be used to acquire and reconstruct internal microstructure of tablets and granules. CT is a technique that is based on attenuation of X-rays passing through matter. Attenuation depends on the density and atomic number of the material that is scanned. In this work, a micro-CT X-ray scanner (manufactured by the group of Applied Nuclear Physics at University of Sorocaba) was used to obtain three-dimensional images of the tablets and granules for nondestructive analysis. These images showed a non uniform density distribution of material inside some tablets, the morphology of some granules analyzed, the integrity of the liquid-filled soft-gelatin capsule and so on. It could also be observed that the distribution of different constituents presents an osmotic controlled-release dosage form. The present work shows that it is possible to use X-ray microtomography to obtain useful qualitative and quantitative information on the structure of pharmaceutical dosage forms. (author)

American Academy of Neurology policy on pharmaceutical and device industry support.

Science.gov (United States)

Hutchins, J C; Rydell, C M; Griggs, R C; Sagsveen, M; Bernat, J L

2012-03-06

To examine the American Academy of Neurology (AAN)'s prevention and limitation of conflicts of interest (COI) related to relationships with pharmaceutical and medical device manufacturers and other medically related commercial product and service companies (industry). We reviewed the AAN's polices governing its interactions with industry, mechanisms for enforcement, and the recent findings of the board-appointed COI task force, in the context of the 2009 David Rothman and colleagues' article in JAMA, the Council of Medical Specialty Societies (CMSS) Code for Interactions with Companies (Code), efforts of the American Medical Association in this area, and increased public and Congressional scrutiny of physician/physician organizations' relationships with industry. The AAN's Policy on Conflicts of Interest provides 4 mechanisms for addressing COI: avoidance, separation, disclosure, and regulation. The AAN's Principles Governing Academy Relationships with External Sources of Support, including recent amendments proposed by the COI task force, regulate industry interaction with AAN programming, products, and leadership. With the Policy, Principles, and other methods of COI prevention, the AAN meets or exceeds all recommendations of the CMSS Code. With its adherence to the Principles since 2004, the AAN has been a leader among professional medical associations in appropriately managing COI related to interactions with industry. Recent amendments to the Principles maintain the AAN's position as a leader in a time of increased public scrutiny of physicians' and professional medical associations' relationships with industry. The AAN is responsive to the recommendations of the COI task force, and has adopted the CMSS Code.

The ethics of the medical-pharmaceutical relationship.

Science.gov (United States)

Vashi, Neelam A; Latkowski, Jo-Ann M

2012-01-01

Physician interaction with the pharmaceutical industry raises many ethical concerns. This relationship is complex, owing to a pluralism of beliefs held by physicians, patients, and third parties. As a result, determining whether physicians fulfill their responsibilities to both the professional and public communities is an arduous endeavor. In an effort to clarify the situation and provide transparency to this complex relationship, medical and pharmaceutical organizations have enacted their own respective codes and guidelines. Even with adherence to these guidelines, questions remain regarding the codependent relationship that interweaves the pharmaceutical industry with the medical community. Owing to the ever-changing landscape enmeshing product development, scientific advancement, corporate realities and patient care, the proper choice for physicians is rarely obvious; however, to operate to the highest standards, those in the medical community must be candid about relations with the pharmaceutical industry and transparent in their financial interests. Further undertakings should focus not on the eradication of physician-pharmaceutical interaction, but instead on the education of physicians about industry marketing strategies and the delineation of boundaries of these interactions to benefit not the individual physician, but our patients. Copyright © 2012. Published by Elsevier Inc.

Implementing Lean Manufacturing in Malaysian Small and Medium Startup Pharmaceutical Company

Science.gov (United States)

Ibrahim, Wan Mohd Khairi bin Wan; Rahman, Mohamed Abdul; Abu Bakar, Mohd Rushdi bin

2017-03-01

Domestic pharmaceutical industry has been identified by the Malaysian government as an industry to be developed under its 11th economic development plan. Most homegrown pharmaceutical companies fall under the category of small and medium enterprises (SME) and therefore need to be highly efficient in their operations to compete with the multinationals. Though lean manufacturing is a well-known methodology to achieve an efficient operation, only a small percentage of the local SMEs implement it. The study aims to determine the real success factors in lean implementation through systematic review of relevant literature on lean manufacturing implementation in local companies, onsite observation of a selected SME company, Global Factor Sdn. Bhd. (GFSB), that successfully implemented lean manufacturing followed by actual implementation of lean project at IKOP Sdn. Bhd., a small startup pharmaceutical company. Lean tools like Gemba, value stream map (VSM) and spaghetti diagram were used to analyze and improve a process at IKOP Sdn. Bhd. The literature review showed that the implementation of lean manufacturing at Malaysian SMEs involved in pharmaceutical industry is at its infancy. Study at GFSB indicated that successful implementation of lean manufacturing stems from management support, employee’s commitment, government support and knowledge on lean among employees. Application of lean tools in IKOP Sdn. Bhd. to improve the process cycle efficiency of hand sanitizer, i-Hand 4.0, has shown that the GMP guidelines are not jeopardized. The Kaizen improvement project resulted in 46.3% reduction in lead time. It may be concluded that implementing lean manufacturing in any small local startup pharmaceutical company is beneficial in reducing operational costs and increasing the efficiency and effectiveness and does not conflict with the existing GMP guidelines.

Globalization : the challenge of the 1990s for the chemical industry

International Nuclear Information System (INIS)

Wilcock, D.

1992-01-01

The challenges facing the chemical industry in Canada were discussed. In recent years, Canada has scored low in polls measuring public confidence in the chemical industry. The industry is also suffering from continuing recession, global competition, increased environmental demands and strict legislation. The impact of globalization, total quality management, free trade, environmental concerns, and government policies on the chemical industry were reviewed. In the view of this author (President and CEO of Dow Chemicals) globalization is not a matter of choice, it is an industry imperative. Survival in the globalized economy will require not only to be successful competitors, but even more importantly to be successful cooperators with other stakeholders, and successful in forming partnerships with customers

Challenges in Building a Global Supply Chain in the Apparel Industry

Directory of Open Access Journals (Sweden)

Vidyaranya B. Gargeya

2001-09-01

Full Text Available The last decade of the twentieth century has been characterized with the growth of global supply chains in a wide variety of industries. Global supply chain management in the apparel industry presents a wide variety of challenges. This paper presents a framework elaborating the challenges associated with communication, cultural relationships, technology, production processes, supplier arrangements, and transportation infrastructure in building a global supply chain in the apparel industry catering primarily to the U.S. market. The paper, in the concluding section, makes a few suggestions for future research in global supply chain management in the apparel industry.

Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry.

Science.gov (United States)

Song, Chie Hoon; Han, Jeung-Whan

2016-01-01

Extending the period of the market exclusivity and responding properly to the recent agglomeration of patent expiries are pivotal to the success of pharmaceutical companies. Declining R&D productivity, rising costs of commercialization, near-term patent expirations for many top-selling drugs are forcing companies to adopt new systems to introduce innovative products to market and to focus on strategies that increase the returns from the existing product portfolio. This systematic review explores various strategic and tactical management approaches by synthesizing the relevant literature and practical examples on patent expiration strategies. It further discusses how the mix of competition policies and strategic instruments can be used to maintain declining revenue streams from the blockbuster business model of the pharmaceutical industry. The review provides a comprehensive overview of the research on various strategies, offers both theoretical and practical guidelines for strategy transformation that companies can use to prolong the market exclusivity, and identifies knowledge gaps that needed to be addressed in order to improve efficiency in policy design.

EVOLUTIONS IN GLOBAL AUTOMOBILES INDUSTRY

OpenAIRE

Viorel Pop

2013-01-01

This paper is a brief overview of the evolution of the global automotive industry during the 20th century, with reference to the main manufacturers, oil crises of 1970-1980, and also the global financial and economic crisis that began in 2008. The analyzed period covers the rise of the Asian Continent, beginning with Japan, then South Korea and more recently the emerging countries: China and India. What was predicted 20-25 years ago, became reality: Asia becomes the economic centre of the wor...

Windows of opportunities and technological innovation in the Brazilian pharmaceutical industry.

Science.gov (United States)

Tigre, Paulo Bastos; Nascimento, Caio Victor Machado França do; Costa, Laís Silveira

2016-11-03

The Brazilian pharmaceutical industry is heavily dependent on external sources of inputs, capital, and technology. However, the emergence of technological opportunities and the development of biotechnology and the decline of the patent boom and resulting advances by generic drugs have opened windows of opportunities for the local industry. The article examines the Brazilian industry's innovative behavior vis-à-vis these opportunities, showing that although the industry as a whole invests little in innovation, a few large Brazilian companies have expanded their market share and stepped up their investments in research and development, supported by public policies for innovation. Resumo: A indústria farmacêutica brasileira caracteriza-se pela grande dependência de fontes externas de insumos, capital e tecnologia. O surgimento de oportunidades tecnológicas, associadas ao desenvolvimento da biotecnologia e ao fim do boom das patentes com o consequente avanço dos medicamentos genéricos, entretanto, vem abrindo janelas de oportunidades para a indústria local. Este artigo examina o comportamento inovador da indústria brasileira à luz dessas oportunidades, revelando que, embora o conjunto da indústria mantenha baixos níveis de investimentos em inovação, um pequeno grupo de grandes empresas nacionais vem ampliando sua participação no mercado e intensificando seus investimentos em pesquisa e desenvolvimento, apoiados por políticas públicas de inovação.

Industry and development: Global report 1991/92

International Nuclear Information System (INIS)

1991-01-01

In the 1980s, but increasingly so within the past two years, opinion has swung decisively in favour of an open, market-oriented economy, for the greater part privately owned and managed, as a way of achieving sustained industrial growth. It is with this knowledge that the Global Report focuses once again on providing detailed, concrete and up-to-date information on the global prospects for industrial growth. This year, special attention is devoted to the issues of efficiency in the use of energy and to the new financial instruments available for manufacturing industries in the global financial markets. An overview of industrial energy consumption and efficiency in the manufacturing sector is presented. Industry is the most important end-user sector in total final energy consumption in most countries. Given the dominant share of manufacturing energy consumption, it is not difficult to see the enormous potential for energy savings through improved energy efficiency in the manufacturing sector, and the substantial economic and environmental benefits to be derived therefrom in both developing and developed countries. The widespread decoupling of output and energy in OECD countries in the past two decades has already been noted, while the opposite phenomenon of energy consumption increasing in step with output has been observed in developing countries during the same period. Conservation and improvements in energy efficiency are therefore of crucial importance in developing countries. Refs, figs and tabs

On the Globalization of the Film Industry

OpenAIRE

Lorenzen, Mark

2010-01-01

The paper presents stylized facts about the economic organisation of the film industry, arguing that while we know a lot about production, specialization and internationalization, the complex processes of globalization are still under-researched. The paper concludes with a research agenda of how to address globalization.

Política farmacéutica saludable Healthy pharmaceutical policy

Directory of Open Access Journals (Sweden)

Eduardo González Pier

2008-01-01

Full Text Available Hoy en día, la industria farmacéutica se encuentra en una transición profunda. La globalización y el avance tecnológico representan las principales presiones de cambio para un mercado mundial de medicamentos donde a este tipo de industria le resulta cada vez más difícil recuperar de forma eficiente los costos crecientes de la innovación. México debe analizar las implicaciones en el ámbito político de estos factores de cambio y promover, en el mercado de medicamentos, una política que incremente al máximo las ganancias de salud de los recursos invertidos. La política de medicamentos ofrece un raro ejemplo de complementariedad entre una buena política de salud y una política económica eficiente, es decir, una "política farmacéutica saludable".Today, the pharmaceutical industry is experiencing a profound transition. Globalization and technological advancement represent the principal pressures for change in the market, where it is increasingly more difficult for this type of industry to efficiently recoup the growing cost of innovation. Mexico needs to analyze the policy implications of these change factors and promote, in the pharmaceutical market, policies that maximize health gains on invested resources. Pharmaceutical policy offers a rare example for a complementary approach between a sound health policy and an efficient economic policy; that is, a "healthy pharmaceutical policy."

PSE in Pharmaceutical Process Development

DEFF Research Database (Denmark)

Gernaey, Krist; Cervera Padrell, Albert Emili; Woodley, John

2011-01-01

The pharmaceutical industry is under growing pressure to increase efficiency, both in production and in process development. This paper will discuss the use of Process Systems Engineering (PSE) methods in pharmaceutical process development, and searches for answers to questions such as: Which PSE...

Open Data for Research and Strategic Monitoring in the Pharmaceutical and Biotech Industry

Directory of Open Access Journals (Sweden)

Baldissera Giovani

2017-04-01

Full Text Available Open data is considered the new oil. As oil can be used to produce fertilisers, pesticides, lubricants, plastics and many other derivatives, so data is considered the commodity to use and re-use to create value. The number of initiatives supporting free access to data has increased in the last years and open data is becoming the norm in the public sector; the approach empowers stakeholders and nurtures the economy. Even if at early stage, private companies also are adapting to the open data market. A survey was conducted to which thirteen companies of different size (from micro enterprises to world-leading pharmas in the pharmaceutical and biotech sector and representing four business models archetypes of companies exploiting open data (aggregators, developers, enrichers and enablers participated. The information collected provides a snapshot of the use of open data by the pharmaceutical and biotech industry in 2015–2016. The companies interviewed use open data to complement proprietary data for research purposes, to implement licensing-in/licensing-out strategies, to map partnerships and connections among players or to identify key expertise and hire staff. Pharmaceutical and biotech companies have made of the protection of knowledge a dogma at the foundation of their business models, but using and contributing to the open data movement may change their approach to intellectual property and innovation.

Pharmaceutical contamination in residential, industrial, and agricultural waste streams: risk to aqueous environments in Taiwan.

Science.gov (United States)

Lin, Angela Yu-Chen; Yu, Tsung-Hsien; Lin, Cheng-Fang

2008-12-01

This is a comprehensive study of the occurrence of antibiotics, hormones and other pharmaceuticals in water sites that have major potential for downstream environmental contamination. These include residential (hospitals, sewage treatment plants, and regional discharges), industrial (pharmaceutical production facilities), and agricultural (animal husbandries and aquacultures) waste streams. We assayed 23 Taiwanese water sites for 97 targeted compounds, of which a significant number were detected and quantified. The most frequently detected compounds were sulfamethoxazole, caffeine, acetaminophen, and ibuprofen, followed closely by cephalexin, ofloxacin, and diclofenac, which were detected in >91% of samples and found to have median (maximum) concentrations of 0.2 (5.8), 0.39 (24.0), 0.02 (100.4), 0.41 (14.5), 0.15 (31.4), 0.14 (13.6) and 0.083 (29.8) microg/L, respectively. Lincomycin and acetaminophen had high measured concentrations (>100 microg/L), and 35 other pharmaceuticals occurred at the microg/L level. These incidence and concentration results correlate well with published data for other worldwide locations, as well as with Taiwanese medication usage data, suggesting a human contamination source. Many pharmaceuticals also occurred at levels exceeding predicted no-effect concentrations (PNEC), warranting further investigation of their occurrence and fate in receiving waters, as well as the overall risks they pose for local ecosystems and human residents. The information provided here will also be useful for development of strategies for regulation and remediation.

On radiation treatment of pharmaceutical products

International Nuclear Information System (INIS)

Zukov, V.; Mende, V.

1976-01-01

The progress made in the GDR over the past decade in the field of radiosterilization of products of the medical industry, has naturally raised the question of radiosterilization in pharmaceutics. However, because of the diversity and complicated nature of pharmaceutical products and, consequently, longer periods of time required for preliminary studies, their radiosterilization has not yet been applied on an industrial scale, in contrast to the situation in the medical industry. The studies carried out so far have been mainly concerned with ascertaining the permissibility and effectiveness of radiosterilization of individual products under particular conditions rather than with laying down a broad theoretical basis. Accordingly, the present paper does not describe results of special studies but presents a brief rewiev of some studies on radiation treatment of pharmaceutical products undertaken in the GDR. (author)

Impact of the Internet on Globalization : Industrial Internet

OpenAIRE

Jukics, Márk

2016-01-01

The thesis consists of two main parts. The first part is the theoretical framework, the second part is about assisting in a project of Centria University of Applied Sciences. The theoretical part of the thesis expounds the evolution and the benefits of the industrial internet. It explains the roots of globalization, internet, and industries. Lean manufacturing and management is also involved in the theory, as this way of management is successfully spreading by the help of globalization. I...

Global Wood Pellet Industry and Trade Study 2017

NARCIS (Netherlands)

Thrän, D.; Peetz, D.; Schaubach, K.; Mai-Moulin, T.; Junginger, H.M.; Lamers, P.; Visser, L.

2017-01-01

The report Global Wood Pellet Industry Market published in 2011 has always been the most downloaded document of IEA Bioenergy Task 40. We have decided to update the report and bring new insights on market trends and trade of the global wood pellets. The global wood pellet market has increased

Pharmaceutical marketing research and the prescribing physician.

Science.gov (United States)

Greene, Jeremy A

2007-05-15

Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue.

[Anti-counterfeit activities of pharmaceutical companies in Japan: for patient safety].

Science.gov (United States)

Shofuda, Ken-ichi; Aragane, Katsumi; Igari, Yasutaka; Matsumoto, Kinya; Ito, Kazuya

2014-01-01

Global spread of counterfeit medicines is an imminent threat for the patients' safety. Although major targets of counterfeits are still erectile dysfunction (ED) drugs in the industrialized countries, including Japan, anti-cancer agents and some medicines for metabolic syndromes are also being counterfeited and circulated to the market mainly through the Internet. Due to the global expansion of the business, pharmaceutical companies based in Japan are suffering from the damage of counterfeits, illegal sales including diversion, and thefts, which have never been experienced in the conventional domestic market. We, pharmaceutical companies, must be responsible for the prevention of the prevalence because our mission is to deliver effective and safe medicine to patients. For this end, we are taking necessary actions including, 1. Forestalling counterfeit, falsification and illicit trade: Measures to prevent counterfeiting are taken by introducing anti-counterfeit technologies to the packaging and tablets on a risk basis. It is also important to establish supply chain security on a global scale. 2. Finding out counterfeits and cooperating crackdown: We are conducting market and internet surveillances when high risk products are sold in high risk markets. The outcome of the criminal investigation is reported to authorities and police if necessary. 3. Conducting educational campaign to medical staff or patients: For example, four companies which manufacture and sell ED drug in Japan are collaboratively continuing activities to raise the awareness of the danger of Internet purchase. To deliver effective and safe medicines stably and globally, pharmaceutical companies extend comprehensive measures against counterfeit and illicit trading.

Specifications from a biotechnology industry perspective.

Science.gov (United States)

Garnick, R L

1997-01-01

The emergence of new analytical technology and the production of pharmaceuticals for a global market in a cost-effective manner necessitate the establishment of worldwide specifications that are appropriate for the product and the manufacturing process. This requires a thorough knowledge of the protein and control of the systems that produce it as well as an understanding of the accuracy and precision of the assays used for testing. Harmonization of specifications among the worldwide regulatory authorities is critical for the future development of new pharmaceuticals. A continuing dialogue between industry and regulators to achieve this goal needs to be encouraged and supported.

Pharmaceutical cocrystals: an overview.

Science.gov (United States)

Qiao, Ning; Li, Mingzhong; Schlindwein, Walkiria; Malek, Nazneen; Davies, Angela; Trappitt, Gary

2011-10-31

Pharmaceutical cocrystals are emerging as a new class of solid drugs with improved physicochemical properties, which has attracted increased interests from both industrial and academic researchers. In this paper a brief and systematic overview of pharmaceutical cocrystals is provided, with particular focus on cocrystal design strategies, formation methods, physicochemical property studies, characterisation techniques, and recent theoretical developments in cocrystal screening and mechanisms of cocrystal formations. Examples of pharmaceutical cocrystals are also summarised in this paper. Copyright © 2011 Elsevier B.V. All rights reserved.

Value of pharmaceuticals: ensuring the future of research and development.

Science.gov (United States)

Serajuddin, Hamida K; Serajuddin, Abu T M

2006-01-01

To analyze the current situation under which the pharmaceutical industry is criticized for the production of drugs with potential adverse effects, the high prices of medicines, and aggressive marketing practices, and to provide a proposal to rectify the situation. Published books, pharmaceutical journals, Web of Science database using the search terms pharmaceutical, research, development, marketing, cost, and the Food and Drug Administration (FDA) Web site. Most breakthroughs in the treatment of diseases and prolongation of lives have come about through pharmaceuticals discovered and developed by the pharmaceutical industry. While the process of discovering and developing new pharmaceuticals is lengthy, costly, and lacking any assurance of success, investment in research and development by the U.S. pharmaceutical industry has increased progressively, reaching 51.3 billion dollars in 2005. Yet the annual number of FDA approvals of new molecular entities (NMEs) has gradually decreased over the past 10 years. Additionally, a large part of the patent life of a successful NME is consumed during this lengthy development phase. Few businesses, if any, have such long product gestation lives and risks. For these reasons, the pharmaceutical industry is often in a rush to recoup its investment before the product's patent expires, and this is the root cause of many criticisms against the pharmaceutical industry. To rectify the current situation, a new system is proposed under which innovator pharmaceutical companies would be allowed royalties for their products after the expiration of patents, in a manner similar to the way in which other intellectual properties (such as books, music, films) are protected by copyright. Such a system would allow pharmaceutical companies to continue research on new pharmaceutical products unimpeded by the patent clock. Given appropriate legislative or other facilitatory actions, a royalty-based system for the marketing of generic products after

Civic Engagement as Risk Management and Public Relations: What the Pharmaceutical Industry Can Teach Us about Service-Learning

Science.gov (United States)

Scott, J. Blake

2009-01-01

The pharmaceutical industry's corporate responsibility reports illustrate how the liberal rhetoric of civic engagement can be reappropriated to serve the market-driven aims of risk management and public relations. Tracing the ideologic linkage of corporate responsibility and service-learning versions of civic engagement, and contextualizing…

Combined aerobic and physicochemical treatment of pharmaceutical industry sludge

International Nuclear Information System (INIS)

Asia, Q.I.; Ademoroti, A.M.C.

2005-01-01

Composite samples of sludge obtained from a pharmaceutical factory were analysed for their pollution characteristics. The samples were then treated by integrated aerobic biological and physicochemical methods. The analysis revealed that the BOD and COD of the sludge liquor were high, as well as were the levels of solids concentration, nitrogen, phosphorus and bacterial count. These showed that sludge from this industry had a high pollution potential, and therefore needed treatment before disposal or reuse in other applications. Percentage solids reduction achieved were in the range of 26.1 to 29% of total soluble solids, 26.1 to 33% of suspended solids, and 43 to 52% of volatile solids, BOD and COD reductions were in the range of 96.1 to 98.2% and 96.8 to 98.4% respectively. Ammonia nitrogen reductions in this sludge were about 85.2 to 93.3%. Total nitrogen and phosphorus were also found to be appreciably reduced by the combined aerobic and physicochemical treatment methods. (author)

Past, present and future of pharmaceutical patents under Korea-US Trade Agreement.

Science.gov (United States)

Shin, Yoon Suk

2016-07-01

The introduction of substance patents in 1987 was viewed with apprehension as it was believed that the system would only reinforce the domination of the technology of advanced countries based on the trade agreement between Korea and the USA. However, substance patents provided the Korean pharmaceutical industry with the driving force required to develop new substances, and the Korean pharmaceutical industry has been constantly improving its research and development capability. The patent-approval linkage system was implemented according to the Korea-US Free Trade Agreement in 2015. The system comprises the following: registering the drugs in the Green List, notifying the listed patent and marketing approval holders about the application for generic marketing approval, patent holder's request for staying generic sales and first generic exclusivity. Korean generic companies are expected to have opportunities that enable them to challenge the global market by accumulating experience of designing of generic products, making patent challenges and strategically developing of new drugs or incrementally modified drugs through the linkage system.

Could the Pharmaceutical Industry Benefit from Full-Scale Adoption of Radio-Frequency Identification (RFID) Technology with New Regulations?

Science.gov (United States)

Coustasse, Alberto; Kimble, Craig A; Stanton, Robert B; Naylor, Mariah

2016-01-01

Healthcare regulators are directing attention to the pharmaceutical supply chain with the passage of the Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA). Adoption of Radio-Frequency Identification (RFID) technology has the ability to improve compliance, reduce costs, and improve safety in the supply chain but its implementation has been limited; primarily because of hardware and tag costs. The purpose of this research study was to analyze the benefits to the pharmaceutical industry and healthcare system of the adoption of RFID technology as a result of newly implemented supply chain regulations. The methodology was a review following the steps of a systematic review with a total of 96 sources used. With the DSCSA, pharmaceutical companies must track and trace prescription drugs across the supply chain, and RFID can resolve many track-and-trace issues with manufacturer control of data. The practical implication of this study is that pharmaceutical companies must continue to have the potential to increase revenues, decrease associated costs, and increase compliance with new FDA regulations with RFID. Still, challenges related to regulatory statute wording, implementation of two-dimensional barcode technology, and the variety of interfaces within the pharmaceutical supply chain have delayed adoption and its full implementation.

A survey of the effects of brand value on customer satisfaction in pharmaceutical and biological industries

Directory of Open Access Journals (Sweden)

Alipour, A.

2016-07-01

Full Text Available . The purpose of this study was to describe how companies in pharmaceutical and biological sectors can ensure their position in different markets by relying on sustainable, competitive advantages, resulting from the use of a well-defined marketing model with particular emphasis on brand improvement. As competition becomes more intense among companies and phenomena such as global marketing grow in importance, domestic industries in each country become obliged to improve their competitive advantages in order to survive from a marketing perspective. Customer satisfaction is among factors which could lead to the success and profitability of a company. The present research examined the relationship between brand value and customer behavioral intention. Accordingly, 80 questionnaires were distributed among customers, selected through random sampling in Tehran, Iran. The obtained data were analyzed by SPSS. Based on descriptive statistics, two aspects of customer behavioral intention included “product introduction” and “repeat purchase”, while two aspects of brand equity were “brand awareness” and “product introduction”. The research findings showed that factors such as “brand awareness” and “brand loyalty” directly affect customer behavioral intention and satisfaction.

The importance of news media in pharmaceutical risk communication: proceedings of a workshop.

Science.gov (United States)

Mebane, Felicia E

2005-05-01

In response to mass media's role in the national and global system of pharmaceutical risk communication, the Centers for Education and Research on Therapeutics (CERTs) convened a 'think tank' session on the 'Importance of Media in Pharmaceutical Risk Communication'. Prominent journalists and experts from the pharmaceutical industry, academia, medical practice and government were invited to consider the benefits and challenges of improving the way we communicate the benefits and risks of therapeutics via mass media, especially news media. Workshop discussions revealed a paucity of systematic research directed towards understanding how and why news media report on therapeutic risk, the impact of this coverage and how coverage can be improved. Consequently, participants produced a research agenda capturing the key aspects of the flow of information around this topic, including the meaning of risk, how news audiences process and use therapeutic risk information in the news, how and why news organizations report on therapeutic risk, and the role and impact of the pharmaceutical industry, government officials and academic researchers as sources of therapeutic risk information. The workshop ended with a discussion on action items addressing what news professionals, representatives of regulatory agencies and the medical products industry, and academic researchers can and should do to enable news media to effectively report therapeutic risk information. In sum, this proceedings report provides an outline for developing mass media risk communication research, influencing the practices of journalists and expert sources and ultimately, improving the quality of the public's life. Copyright (c) 2004 John Wiley & Sons, Ltd.

Internationalization and technological leapfrogging in the pharmaceutical industry

OpenAIRE

Suma Athreye; Andrew Godley

2009-01-01

The pre-refereed author version of this article was published as a UNI-MERIT Working Paper under the title “Internationalising to create Firm Specific Advantages: Leapfrogging strategies of U.S. Pharmaceutical firms in the 1930s and 1940s & Indian Pharmaceutical firms in the 1990s and 2000s”. The paper can be downloaded from the UNU-MERIT website from the following link: http://arno.unimaas.nl/show.cgi?fid=12607. Internationalization is a useful strategy for gaining firm-specific technolog...

The present effect of global warming on U.S. industry

International Nuclear Information System (INIS)

Bendel, W.B.

1993-01-01

This paper will discuss how global warming issues are currently affecting U.S. industry. Global climate models are projecting global temperature increases in the 1.5-4.5 degrees C range within the next 50-60 years. This increase is based on the assumption that CO 2 emissions into the atmosphere will continue to increase 1-2% per year, resulting in a doubling of preindustrial CO 2 levels by mid twenty-first century. These projections may cause U.S. industry to readjust its thinking with respect to the benefits of pollution prevention as they relate to global warming, corporate image enhancement, global competitiveness and risk assessment or balance. Real or perceived impacts of global warming are already influencing U.S. competitiveness within the global economy because Japan and the European countries are taking the global warming threat more seriously than is the U.S. Mitigation of CO 2 emissions through carbon taxes or permitting will be discussed. Options available to U.S. industry to deal with the current uncertainties of global warming will be presented. Examples of how specific companies are coping with this issue will be given. Finally, recommendations are presented for proactive planning to determine which segments, divisions or facilities in a multinational company would be most sensitive to CO 2 stabilization regulations

Trends in the global aluminum fabrication industry

Science.gov (United States)

Das, Subodh; Yin, Weimin

2007-02-01

The aluminum fabrication industry has become more vital to the global economy as international aluminum consumption has grown steadily in the past decades. Using innovation, value, and sustainability, the aluminum industry is strengthening its position not only in traditional packaging and construction applications but also in the automotive and aerospace markets to become more competitive and to face challenges from other industries and higher industrial standards. The aluminum fabrication industry has experienced a significant geographical shift caused by rapid growth in emerging markets in countries such as Brazil, Russia, India, and China. Market growth and distribution will vary with different patterns of geography and social development; the aluminum industry must be part of the transformation and keep pace with market developments to benefit.

Preclinical QSP Modeling in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape

Science.gov (United States)

Wu, Fan; Bansal, Loveleena; Bradshaw‐Pierce, Erica; Chan, Jason R.; Liederer, Bianca M.; Mettetal, Jerome T.; Schroeder, Patricia; Schuck, Edgar; Tsai, Alice; Xu, Christine; Chimalakonda, Anjaneya; Le, Kha; Penney, Mark; Topp, Brian; Yamada, Akihiro

2018-01-01

A cross‐industry survey was conducted to assess the landscape of preclinical quantitative systems pharmacology (QSP) modeling within pharmaceutical companies. This article presents the survey results, which provide insights on the current state of preclinical QSP modeling in addition to future opportunities. Our results call attention to the need for an aligned definition and consistent terminology around QSP, yet highlight the broad applicability and benefits preclinical QSP modeling is currently delivering. PMID:29349875

Widening the debate about conflict of interest: addressing relationships between journalists and the pharmaceutical industry.

Science.gov (United States)

Lipworth, Wendy; Kerridge, Ian; Sweet, Melissa; Jordens, Christopher; Bonfiglioli, Catriona; Forsyth, Rowena

2012-08-01

The phone-hacking scandal that led to the closure of the News of the World newspaper in Britain has prompted international debate about media practices and regulation. It is timely to broaden the discussion about journalistic ethics and conduct to include consideration of the impact of media practices upon the population's health. Many commercial organisations cultivate relationships with journalists and news organisations with the aim of influencing the content of health-related news and information communicated through the media. Given the significant influence of the media on the health of individuals and populations, we should be alert to the potential impact of industry-journalist relationships on health care, health policy and public health. The approach taken by the medical profession to its interactions with the pharmaceutical industry provides a useful model for management of industry influence.

New opportunities for biocatalysis: making pharmaceutical processes greener

DEFF Research Database (Denmark)

Woodley, John

2008-01-01

The pharmaceutical industry requires synthetic routes to be environmentally compatible as well as to fulfill the demands of process economics and product specification and to continually reduce development times. Biocatalysis has the potential to deliver 'greener' chemical syntheses, and in this ......The pharmaceutical industry requires synthetic routes to be environmentally compatible as well as to fulfill the demands of process economics and product specification and to continually reduce development times. Biocatalysis has the potential to deliver 'greener' chemical syntheses...... of biocatalysis for making pharmaceutical processes greener....

The return of the pharmaceutical industry to the market of contraception.

Science.gov (United States)

Johansson, E D

2000-01-01

In the 1980s and 1990s, the litigious climate in the US had a catastrophic effect on sales of many major contraceptives. Although oral contraceptives escaped controversy, the intrauterine device (IUD) and Norplant(R) were two targets of damaging litigation. The IUD was withdrawn from the market in 1985. Since 1994 when the attacks began against Norplant, its US sales have dramatically declined, even though no fault has been found in the method or its development. In general, pharmaceutical companies were extremely hesitant to develop new contraceptives during this period. The bleak outlook, however, began to shift in the late 1990s, as fertility rates began to decrease worldwide and contraceptive users increased. By 2025, 2500 million women will comprise the customer base for contraception. Global pharmaceutical companies are now participating in expanding markets overseas and have launched and continue to develop a range of new long-term reversible, and highly effective, contraceptive products outside the traditional oral contraceptive field. Two new contraceptives on the way to the US market are: Mirena, a levonorgestrel-releasing intrauterine system manufactured by Schering-Leiras; and Implanon, a single implant system manufactured by Organon of the Netherlands. Other birth control methods soon to be launched include: emergency contraceptives, the contraceptive patch, monthly contraceptive injections, mifepristone for medical abortion, and modified oral contraceptives.

Monitoring of trace metals and pharmaceuticals as anthropogenic and socio-economic indicators of urban and industrial impact on surface waters

Science.gov (United States)

Vystavna, Yuliya

2014-05-01

The research focuses on the monitoring of trace metals and pharmaceuticals as potential anthropogenic indicators of industrial and urban influences on surface water in poorly gauged transboundary Ukraine/Russia region. This study includes analysis of tracers use for the indication of water pollution events, including controlled and emerging discharges, and discussion of the detection method of these chemicals. The following criteria were proposed for the evaluation of indicators: specificity (physical chemical properties), variability (spatial and temporal) and practicality (capacity of the sampling and analytical techniques). The combination of grab and passive water sampling (i.e. DGT and POCIS) procedure was applied for the determination of dissolved and labile trace metals (Ag, Cd, Cr, Cu, Ni, Pb and Zn) and pharmaceuticals (carbamazepine, diazepam, paracetamol, caffeine, diclofenac and ketoprofen). Samples were analysed using ICP - MS (trace metals) and LC-MS/MS ESI +/- (pharmaceuticals). Our results demonstrate the distinctive spatial and temporal patterns of trace elements distribution along an urban watercourse. Accordingly, two general groups of trace metals have been discriminated: 'stable' (Cd and Cr) and 'time-varying' (Cu, Zn, Ni and Pb). The relationship Cd >> Cu > Ag > Cr ≥ Zn was proposed as an anthropogenic signature of the industrial and urban activities pressuring the environment from point sources (municipal wastewaters) and the group Pb - Ni was discussed as a relevant fingerprint of the economic activity (industry and transport) mainly from non-point sources (run-off, atmospheric depositions, etc.). Pharmaceuticals with contrasting hydro-chemical properties of molecules (water solubility, bioaccumulation, persistence during wastewater treatment processes) were discriminated on conservative, labile and with combined properties in order to provide information on wastewater treatment plant efficiency, punctual events (e.g. accidents on sewage

The need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Respect of Ethics and Excellence in Science (GREES).

Science.gov (United States)

Bruyere, O; Kanis, J A; Ibar-Abadie, M-E; Alsayed, N; Brandi, M L; Burlet, N; Cahall, D L; Chines, A; Devogelaer, J-P; Dere, W; Goel, N; Hughes, N; Kaufman, J-M; Korte, S; Mitlak, B H; Niese, D; Rizzoli, R; Rovati, L C; Reginster, J-Y

2010-05-01

This paper provides recommendations for fair and unbiased relationship between academic scientists and the pharmaceutical industry. Real or perceived problems in the relationship between academics and the industry have been the subject of much recent debate. It has been suggested that academic clinicians should sever all links with the industry-a view that is rarely challenged. Academic experts and members of the pharmaceutical industry were invited to an expert consensus meeting to debate this topic. This meeting was organized by the Group for the Respect of Ethics and Excellence in Science. Conflict of interest, competing interest, right and duties of academic scientist, authorship, and staff and student education were discussed. Guidelines for a transparent, ethical, strong, and successful partnership between the academic scientist and the pharmaceutical industry have been provided. The Group support interactions between the industry and clinicians provided that it is transparent and ethical.

World pharmaceuticals--Financial Times tenth annual conference. 22-23 April 1999, London, UK.

Science.gov (United States)

Muhsin, M

1999-07-01

This two-day conference was organized by The Financial Times, in association with PriceWaterhouseCoopers LLP. The general theme of the event was the state of the healthcare industry, past, present and future. The main areas covered included addressing the challenges of the 1990s, anticipating the challenges of the next decade, the changing shape of global marketing, IT in healthcare, consolidation challenges, shareholder expectations, and new strategies and technologies for growth sustenance within the industry. Key speakers within the industry addressed these issues to an audience of approximately 200 healthcare business executives. The first day was chaired by Mr Robert Cawthorn (Chairman Emeritus, Rhone-Poulenc Rorer Inc) and the second by Professor Trevor Jones (Director General, Association of the British Pharmaceutical Industry).

Interactions between physicians and the pharmaceutical industry generally and sales representatives specifically and their association with physicians' attitudes and prescribing habits: a systematic review.

Science.gov (United States)

Fickweiler, Freek; Fickweiler, Ward; Urbach, Ewout

2017-09-27

The objective of this review is to explore interactions between physicians and the pharmaceutical industry including sales representatives and their impact on physicians' attitude and prescribing habits. PubMed, Embase, Cochrane Library and Google scholar electronic databases were searched from 1992 to August 2016 using free-text words and medical subject headings relevant to the topic. Studies included cross-sectional studies, cohort studies, randomised trials and survey designs. Studies with narrative reviews, case reports, opinion polls and letters to the editor were excluded from data synthesis. Two reviewers independently extracted the data. Data on study design, study year, country, participant characteristics, setting and number of participants were collected. Pharmaceutical industry and pharmaceutical sales representative (PSR) interactions influence physicians' attitudes and their prescribing behaviour and increase the number of formulary addition requests for the company's drug. Physician-pharmaceutical industry and its sales representative's interactions and acceptance of gifts from the company's PSRs have been found to affect physicians' prescribing behaviour and are likely to contribute to irrational prescribing of the company's drug. Therefore, intervention in the form of policy implementation and education about the implications of these interactions is needed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

LIFE CYCLE OF THE PHARMACEUTICAL PRODUCT AND PRIMARY STRATEGIC GOALS

Directory of Open Access Journals (Sweden)

Cristina\tCIOT

2015-12-01

Full Text Available In addition to innovation, production at high standards, market and marketing policy, pharmaceutical companies need strategies that could cope with apparent contradictions, convergences and divergences, centralisation and involution, at the global and local level, focus and liberty, domestic production and external supply, ownership and alliances, networks and hierarchies, science or market orientation, all these being part of the essence of a profitable and expanding pharmaceutical company. Specialists appreciate that the 20 century will remain in the collective memory for its technological achievements, including a better understanding of the atomic structure, „information explosion” encouraged by the progress of the computer technology, the news from space exploration. If one wants to evaluate its importance in terms of impact on people’s lives, the 20 century could be called THE DRUG AREA. Many experts agree that, at the end of this century, pharmaceutical products would have a higher importance for our lives due to the special progress in neurobiology, immunology, molecular biology, cellular differentiation, cell membrane and genetic studies. In the pharmaceutical industry, important funds are directed towards research and development, while few understand and appreciate the contribution brought by the pharmaceutical marketing system and by the professionals in this field. These ones make the drug accessible at the right time and place, in the required quantity, at a reasonable price and with all the information required.

Legal considerations for social media marketing by pharmaceutical industry.

Science.gov (United States)

Yang, Y Tony; Chen, Brian

2014-01-01

Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.

Global Commodity Chains in Crisis : The Garment Industry in Malaysia

OpenAIRE

Vicki Crinis

2012-01-01

This paper examines the garment industry in Malaysia from the 1970s to the present. It looks at the strategies employed by manufacturers to cope with both the end of the Multi-fibre Arrangement (MFA) and the effects of the global economic crisis on the industry in Malaysia. The garment industry in Malaysia is situated on the periphery and is almost totally reliant on contracts from the United States (US) and Europe for its survival. Since the global economic recession, contraction in the cons...

The politics and strategy of industry self-regulation: the pharmaceutical industry's principles for ethical direct-to-consumer advertising as a deceptive blocking strategy.

Science.gov (United States)

Arnold, Denis G; Oakley, James L

2013-06-01

As the pharmaceutical industry lobbies European regulators to permit direct-to-consumer advertising (DTCA) of prescription drugs in the European Union, we found that five leading companies violated industry-developed and -promulgated standards for ethical advertising in the United States. Utilizing multiple data sources and methods, we demonstrate a consistent failure by companies that market erectile dysfunction drugs to comply with the industry's guiding principles for ethical DTCA over a four-year period despite pledges of compliance by company leaders. Noncompliance resulted in children being exposed to sexually themed promotional messages more than 100 billion times. We argue that the guidelines are a coordinated effort by the industry to prevent unwanted federal regulation, and we introduce the concept of a blocking strategy to explain company behavior and to advance theoretical understanding of firms' public affairs strategies. We recommend policy responses to prevent deceptive practices, protect children from adult content, and promote genuine health care education.

Approaches to education of pharmaceutical biotechnology in faculties of pharmacy.

Science.gov (United States)

Calis, S; Oner, F; Kas, S; Hincal, A A

2001-06-01

Pharmaceutical biotechnology is developing rapidly both in academic institutions and in the biopharmaceutical industry. For this reason, FIP Special Interest Group of Pharmaceutical Biotechnology decided to develop a questionnaire concerning pharmaceutical biotechnology education. After preliminary studies were completed, questionnaires were sent to the leading scientists in academia and research directors or senior managers of various Pharmaceutical Biotechnology Companies in order to gather their views about how to create a satisfactory program. The objectives of this study were as follows: -To review all of the graduate and undergraduate courses which are presently available worldwide on pharmaceutical biotechnology in Faculties of Pharmacy. -To review all of the text books, references and scientific sources available worldwide in the area of pharmaceutical biotechnology. When replying to the questionnaires, the respondents were asked to consider the present status of pharmaceutical biotechnology education in academia and future learning needs in collaboration with the biotechnology industry. The data from various pharmacy faculties and biotechnology industry representatives from Asia, Europe and America were evaluated and the outcome of the survey showed that educational efforts in training qualified staff in the rapidly growing field of pharmaceutical biotechnology is promising. Part of the results of this questionnaire study have already been presented at the 57th International Congress of FIP Vancouver, Canada in 1997.

The Pharmaceutical Sector of Kazakhstan's Economy: Trends and Problems

Science.gov (United States)

Nurpeisov, Borankul G.; Nabiev, Erboz N.; Mukashev, Temirbay A.; Daribekov, Serik S.; Raimbekov, Bagdat Kh.; Asanova, Maral K.; Bazarbaeva, Leila M.

2016-01-01

This research is devoted to the investigation of the general trends in the development of the pharmaceutical industry in the current conditions of economical socialization. The determination of the economic specificity of the modern operation of the pharmaceutical industry is the purpose of the research. It was found that pharmacy is a profitable…

Determinants of Pharmaceutical Industry’s Performance in Nigeria

Directory of Open Access Journals (Sweden)

Wakeel A. Isola

2016-09-01

Full Text Available This study focused on the relationships amongmarket structure, efficiency and performance of the Nigerian Pharmaceutical industry. It employed market share and operational efficiency to determine the efficiency of the industry, pre-tax return on asset to measure performance, Herfindahl- Hirschman index to measure market structure. In addition, earnings per share was used in the study as control variable. Data were obtained from the Nigerian Stock Market Factbook covering 1996 to 2010. The panel ordinary least squares technique was employed in estimating the data. Thus over the course of the study, both fixed and random effect results clearly showed that efficiency hypothesis does not hold in the case of pharmaceutical industry in Nigeria. Rather, it is shown that it is structure that determines performance. Consequently, the study recommended that necessary structures must be put in place by the Federal Ministry of Health to enhance the capacity of local pharmaceutical firms in producing the desired quality and quantity drugs needed in the country. It was also recommended that efforts should be geared towards eradicating totally the importation of fake drugs in the pharmaceutical industry.

Exploring Multidimensional View of Intellectual Capital and Business Ethics on Organizational Performance by Using Bootstrapping Method: Evidence from Pakistani Pharmaceutical Industry

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Rizwan Raheem Ahmed

2017-03-01

Full Text Available The objective of this research is to examine the effect of business ethics (BE and intellectual capital (IC on the organizational performance (OP. In order to run this study, a conceptual model was designed based on the literature review, and the employees of the knowledge-based organization in pharmaceutical sector were surveyed using a closed-ended questionnaire. Modern successful and thriving organizations are those that create IC and convert it into applicable methods to improve their activities and performance within the boundaries of BE. This research is exploratory and quantitative in nature: 400 responses were directly gathered from the employees of the pharmaceutical industry through five-scaled questionnaire. This research examined the direct and indirect effect of BE and IC on the OP. Structural equation modeling (SEM, descriptive statistics, correlation, multiple regression techniques were used to analyze the impact of IC and BE on the performance. Bootstrapping method is employed in order to test the mediating effect of variables. Two-step SEM was used to the models to regress the cause and effect relation. The findings depicted that there is a very significant effect on BE and IC in the performance of pharmaceutical organizations. General BE, ethics in finance, ethics in human resource management, and ethics in sales and marketing have direct and significant impact on the OP. Human capital, structural capital and relational capital have significant indirect (mediating effect on the performance of the pharmaceutical industry. Finally, it has been concluded from the results of the research study that IC is the major contributor of the OP as a mediating variable with defined set of principles of BE in the pharmaceutical sector of Pakistan.

Pharmaceuticals, political money, and public policy: a theoretical and empirical agenda.

Science.gov (United States)

Jorgensen, Paul D

2013-01-01

Why, when confronted with policy alternatives that could improve patient care, public health, and the economy, does Congress neglect those goals and tailor legislation to suit the interests of pharmaceutical corporations? In brief, for generations, the pharmaceutical industry has convinced legislators to define policy problems in ways that protect its profit margin. It reinforces this framework by selectively providing information and by targeting campaign contributions to influential legislators and allies. In this way, the industry displaces the public's voice in developing pharmaceutical policy. Unless citizens mobilize to confront the political power of pharmaceutical firms, objectionable industry practices and public policy will not change. Yet we need to refine this analysis. I propose a research agenda to uncover pharmaceutical influence. It develops the theory of dependence corruption to explain how the pharmaceutical industry is able to deflect the broader interests of the general public. It includes empirical studies of lobbying and campaign finance to uncover the means drug firms use to: (1) shape the policy framework adopted and information used to analyze policy; (2) subsidize the work of political allies; and (3) influence congressional voting. © 2013 American Society of Law, Medicine & Ethics, Inc.

Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients

DEFF Research Database (Denmark)

Malwade, Chandrakant Ramkrishna; Qu, Haiyan

2018-01-01

Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing of Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities...... parameters and their impact on quality of APIs and subsequently the drug products assume great significance for pharmaceutical industry. Methods: This review paper focuses on application of PAT tools, an integral part of Quality by Design (QbD) approach, for better understanding, control, and design...

Marketing norm perception among medical representatives in Indian pharmaceutical industry.

Science.gov (United States)

Nagashekhara, Molugulu; Agil, Syed Omar Syed; Ramasamy, Ravindran

2012-03-01

Study of marketing norm perception among medical representatives is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the perception of marketing norms among medical representatives. The research design is quantitative and cross sectional study with medical representatives as unit of analysis. Data is collected from medical representatives (n=300) using a simple random and cluster sampling using a structured questionnaire. Results indicate that there is no difference in the perception of marketing norms among male and female medical representatives. But there is a difference in opinion among domestic and multinational company's medical representatives. Educational back ground of medical representatives also shows the difference in opinion among medical representatives. Degree holders and multinational company medical representatives have high perception of marketing norms compare to their counterparts. The researchers strongly believe that mandatory training on marketing norms is beneficial in decision making process during the dilemmas in the sales field.

Alkaloids in the pharmaceutical industry: Structure, isolation and application

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Nikolić Milan

2003-01-01

Full Text Available By the end of the 18th and the beginning of the 19th century a new era began in medicine, pharmaceutics and chemistry that was strongly connected with alkaloids and alkaloid drugs. Even before that it was known that certain drugs administered in limited doses were medicines, and toxic if taken in larger doses (opium, coke leaves, belladonna roots, monkshood tubers crocus or hemlock seeds. However, the identification, isolation and structural characterization of the active ingredients of the alkaloid drugs was only possible in the mid 20th century by the use of modern extraction equipment and instrumental methods (NMR, X-ray diffraction and others.In spite of continuing use over a long time, there is still great interest in investigating new drugs, potential raw materials for the pharmaceutical industry, as well as the more detailed investigation and definition of bio-active components and the indication of their activity range, and the partial synthesis of new alkaloid molecules based on natural alkaloids. The scope of these investigations, especially in the field of semi-synthesis is to make better use of the bio-active ingredients of alkaloid drugs, i.e. to improve the pharmacological effect (stronger and prolonged effect of the medicine, decreased toxicity and side effects, or to extend or change the applications. A combined classification of alkaloids was used, based on the chemical structure and origin, i.e. the source of their isolation to study alkaloid structure. For practical reasons, the following classification of alkaloids was used: ergot alkaloids, poppy alkaloids, tropanic alkaloids purine derivative alkaloids, carbon-cyclic alkaloids, and other alkaloids. The second part of this report presents a table of general procedures for alkaloid isolation from plant drugs (extraction by water non-miscible solvents, extraction by water-miscible solvents and extraction by diluted acid solutions. Also, methods for obtaining chelidonine and

The World Health Organization and the Pharmaceutical Industry. Common areas of interest and differing views.

Science.gov (United States)

Hardwicke, Caroline J

2002-01-01

No article published in the scientific press in the last 10 years reviews the various areas of interest common to the World Health Organization (WHO) and the pharmaceutical industry. Despite a vast amount of information in the public domain, the policies expound the views only of the bodies they represent rather than comparing differing views. An understanding of the factors which affect the interaction between these organisations as well as the organisational structures and the actual areas of intersecting interest, may help to find ways for the industry to assist the WHO in its endeavours in developing countries. Modern drug development is performed initially in and for western society, leaving the areas of infectious or tropical diseases with relatively less industry investment than cancer and cardiovascular disorders. Aspects of the development of an ethical drug, regardless of its therapeutic class (selection of drug name, intellectual property rights, drug safety, marketing and pricing, quality assurance and counterfeiting, generic use, emerging drug donations) are influenced to varying degrees by the triad of money, politics and medical need and the perspectives (each defensible) placed thereon by the WHO and industry. Instead of simply defending their positions combining the best of these strategies to optimise drug development for the needs of developing countries appears logical. Similarly, via its philanthropic initiatives, industry will have donated over $US1 billion in drug and research aid in the period 1995 to 2005. These charitable projects should yield useful information for planning and organising future aid efforts. Global warming, only recently given serious governmental consideration, is an area not yet addressed in drug development policy although along with geographical effects, it is likely to have an impact on the epidemiology of diseases e.g. malaria returning to the Mediterranean, worldwide. With changing disease patterns (and

Funding pharmaceutical innovation through direct tax credits.

Science.gov (United States)

Lybecker, Kristina M; Freeman, Robert A

2007-07-01

Rising pharmaceutical prices, increasing demand for more effective innovative drugs and growing public outrage have heightened criticism of the pharmaceutical industry. The public debate has focused on drug prices and access. As a consequence, the patent system is being reexamined as an efficient mechanism for encouraging pharmaceutical innovation and drug development. We propose an alternative to the existing patent system, instead rewarding the innovating firm with direct tax credits in exchange for marginal cost pricing. This concept is based on the fundamental assumption that innovation that benefits society at large may be financed publicly. As an industry which produces a social good characterized by high fixed costs, high information and regulatory costs, and relatively low marginal costs of production, pharmaceuticals are well-suited to such a mechanism. Under this proposal, drug prices fall, consumer surplus increases, access is enhanced, and the incentives to innovate are preserved.

Attitude and practice of dental surgeons towards pharmaceutical companies' marketing gifts.

Science.gov (United States)

Tahir, Shaila; Rafique, Adeela; Ghafoor, Farkhanda; Saleem, Akif; Khan, Amanullah

2013-01-01

Interaction of pharmaceutical companies (PC) with healthcare services has been a reason for concern. In medicine, awareness of the ethical implications of these interactions have been emphasized upon, while this issue has not been highlighted in dentistry. This study undertook a cross-sectional rapid assessment procedure to gather views of dentists in various institutions towards unethical practices in health care and pharmaceutical industry. The purpose of this study was to assess the need for the formulation and implementation of guidelines for the interaction of dentists with the pharmaceutical and device industry in the best interest of patients. A group of 209 dentists of Lahore including faculty members, demonstrators, private practitioners and fresh graduates responded to a questionnaire to assess their attitudes and practices towards pharmaceutical companies' marketing gifts. The study was conducted during 2011 and provided interesting data that showed the pharmaceutical industry is approaching private practitioners more frequently than academicians and fresh graduates. Private practioners accepted the gifts but mostly recognized them as unethical (over 65%). Both groups considered sponsoring of on-campus lectures as acceptable (over 70%). Respondents are not fully aware of the ethical demands which are imperative for all health care industries, and there is a dire need of strict guidelines and code of ethics for the dentist's interaction with the pharmaceutical and device industry so that patient interest is protected.

Continuous improvement concepts as a link between quality assurance and implementation of cleaner production: Case study in the generic pharmaceutical industry

Directory of Open Access Journals (Sweden)

Boltić Zorana

2016-01-01

Full Text Available The subject and the research objective presented in this article is establishing of the relationship between quality assurance and implementation of cleaner production in the generic pharmaceutical industry through the comprehensive concept of continuous improvement. This is mostly related to application of Lean and Six Sigma tools and techniques for process improvement and their link to other known concepts used in the industrial environment, especially manufacturing of generic pharmaceutical products from which two representative case studies were selected for comparative analysis, also considering relevant regulatory requirements in the field of quality management, as well as appropriate quality standards. Although the methodology discussed in this conceptual and practice oriented article is strongly related to chemical engineering, the focus is mainly on process industry, i.e. production systems, rather than any specific technological process itself. The scope of this research is an engineering approach to evaluation of the production systems in terms of continuous improvement concepts application, considering both quality aspects and efficiency of such systems. [Projekat Ministarstva nauke Republike Srbije, br. TR 34009

The Industry of Pharmaceuticals between Competitive Development and Welfare

OpenAIRE

Gianfrate Fabrizio

2007-01-01

This paper would like to give a contribution to the discussion on which policies and rules should be adopted in order to relaunch the pharmaceutical sector in Italy. Due to its intrinsic features, social value and being one of the most regulated and strategic as based on innovation, this sector has higly specific economic and market peculiarities. Compatibility between the level of NHS expenditure for pharmaceutical provision, equity on medicines acces by the population without any kind of di...

Knowledge, Beliefs and Attitudes of Patients and the General Public towards the Interactions of Physicians with the Pharmaceutical and the Device Industry: A Systematic Review.

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Racha Fadlallah

Full Text Available To systematically review the evidence on the knowledge, beliefs, and attitudes of patients and the general public towards the interactions of physicians with the pharmaceutical and the device industry.We included quantitative and qualitative studies addressing any type of interactions between physicians and the industry. We searched MEDLINE and EMBASE in August 2015. Two reviewers independently completed data selection, data extraction and assessment of methodological features. We summarized the findings narratively stratified by type of interaction, outcome and country.Of the 11,902 identified citations, 20 studies met the eligibility criteria. Many studies failed to meet safeguards for protecting from bias. In studies focusing on physicians and the pharmaceutical industry, the percentages of participants reporting awareness was higher for office-use gifts relative to personal gifts. Also, participants were more accepting of educational and office-use gifts compared to personal gifts. The findings were heterogeneous for the perceived effects of physician-industry interactions on prescribing behavior, quality and cost of care. Generally, participants supported physicians' disclosure of interactions through easy-to-read printed documents and verbally. In studies focusing on surgeons and device manufacturers, the majority of patients felt their care would improve or not be affected if surgeons interacted with the device industry. Also, they felt surgeons would make the best choices for their health, regardless of financial relationship with the industry. Participants generally supported regulation of surgeon-industry interactions, preferably through professional rather than governmental bodies.The awareness of participants was low for physicians' receipt of personal gifts. Participants also reported greater acceptability and fewer perceived influence for office-use gifts compared to personal gifts. Overall, there appears to be lower awareness

Knowledge, Beliefs and Attitudes of Patients and the General Public towards the Interactions of Physicians with the Pharmaceutical and the Device Industry: A Systematic Review.

Science.gov (United States)

Fadlallah, Racha; Nas, Hala; Naamani, Dana; El-Jardali, Fadi; Hammoura, Ihsan; Al-Khaled, Lina; Brax, Hneine; Kahale, Lara; Akl, Elie A

2016-01-01

To systematically review the evidence on the knowledge, beliefs, and attitudes of patients and the general public towards the interactions of physicians with the pharmaceutical and the device industry. We included quantitative and qualitative studies addressing any type of interactions between physicians and the industry. We searched MEDLINE and EMBASE in August 2015. Two reviewers independently completed data selection, data extraction and assessment of methodological features. We summarized the findings narratively stratified by type of interaction, outcome and country. Of the 11,902 identified citations, 20 studies met the eligibility criteria. Many studies failed to meet safeguards for protecting from bias. In studies focusing on physicians and the pharmaceutical industry, the percentages of participants reporting awareness was higher for office-use gifts relative to personal gifts. Also, participants were more accepting of educational and office-use gifts compared to personal gifts. The findings were heterogeneous for the perceived effects of physician-industry interactions on prescribing behavior, quality and cost of care. Generally, participants supported physicians' disclosure of interactions through easy-to-read printed documents and verbally. In studies focusing on surgeons and device manufacturers, the majority of patients felt their care would improve or not be affected if surgeons interacted with the device industry. Also, they felt surgeons would make the best choices for their health, regardless of financial relationship with the industry. Participants generally supported regulation of surgeon-industry interactions, preferably through professional rather than governmental bodies. The awareness of participants was low for physicians' receipt of personal gifts. Participants also reported greater acceptability and fewer perceived influence for office-use gifts compared to personal gifts. Overall, there appears to be lower awareness, less concern and

Pharmaceutical compounds in drinking water

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Vikas Chander

2016-06-01

Full Text Available Pharmaceutical products and their wastes play a major role in the degradation of environment. These drugs have positive as well as negative consequences on different environmental components including biota in different ways. Many types of pharmaceutical substances have been detected with significant concentrations through various advanced instrumental techniques in surface water, subsurface water, ground water, domestic waste water, municipal waste water and industrial effluents. The central as well as state governments in India are providing supports by creating excise duty free zones to promote the pharmaceutical manufacturers for their production. As a result, pharmaceutical companies are producing different types of pharmaceutical products at large scale and also producing complex non-biodegradable toxic wastes byproducts and releasing untreated or partially treated wastes in the environment in absence of strong regulations. These waste pollutants are contaminating all types of drinking water sources. The present paper focuses on water quality pollution by pharmaceutical pollutants, their occurrences, nature, metabolites and their fate in the environment.

Innovation and technology transfer through global value chains: Evidence from China's PV industry

International Nuclear Information System (INIS)

Zhang, Fang; Gallagher, Kelly Sims

2016-01-01

China's success as a rapid innovation follower in the infant Photovoltaic (PV) industry surprised many observers. This paper explores how China inserted itself into global clean energy innovation systems by examining the case of the solar PV industry. The paper decomposes the global PV industrial value chain, and determines the main factors shaping PV technology transfer and diffusion. Chinese firms first entered PV module manufacturing through technology acquisition, and then gradually built their global competitiveness by utilizing a vertical integration strategy within segments of the industry as well as the broader PV value chain. The main drivers for PV technology transfer from the global innovation system to China are global market formation policy, international mobilization of talent, the flexibility of manufacturing in China, and belated policy incentives from China's government. The development trajectory of the PV industry in China indicates that innovation in cleaner energy technologies can occur through both global and national innovation processes, and knowledge exchange along the global PV value chain. - Highlights: •The value chain analytical approach is synergized with the theories of technology transfer and innovation systems. •A detailed review of how China integrated itself into the global solar PV innovation system is provided. •Four main factors shape PV technology transfer to China across various value chain segments. •Innovation in cleaner energy technologies is a combination of global and national innovation processes.

ASEAN GMP and pharmaceutical industries in Indonesia.

Science.gov (United States)

Soesilo, S; Sitorus, U

1995-01-01

Indonesia was appointed by the ASEAN Technical Cooperation in Pharmaceutical as a focal point and to coordinate the development of practical guidelines for the implementation of GMP. The ASEAN GMP Guidelines were endorsed by the ASEAN Technical Cooperation in Pharmaceutical in 1988, which among others required separation of Beta-Lactam dedicated facilities and three degrees of cleanliness for production areas. As it was realised that drug manufacturers in developing countries need more detailed guidelines to be able to implement the GMP, an Operational Manual for GMP was also prepared for providing examples of SOPs lay-outs, documentation etc. It was agreed by the technical cooperation group to leave the implementation of GMP to each member country. However, the ASEAN Manual for Inspection of GMP was drafted and endorsed by the group and training of ASEAN Drug Inspectors was organized to support the implementation. The ASEAN GMP is being implemented in Indonesia through a five-year, stepwise implementation plan, starting in 1989.

Pharmaceutical policy and the lay public

DEFF Research Database (Denmark)

Traulsen, Janine Marie; Almarsdóttir, Anna Birna

2005-01-01

Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient organisati......Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient...... organisations, industry and, most recently, the media. Although the overall aim of health and pharmaceutical policy is to address the needs of all citizens, there are only a few, well organised groups who are actually consulted and involved in the policymaking process, often with the support of the industry....... The reasons for this lack of citizen involvement in health and pharmaceutical policymaking are many, for example: there is no consensus about what public involvement means; there is a predominance of special interest groups with narrow, specific agendas; not all decision makers welcome lay participation...

Solar photo-degradation of a pharmaceutical wastewater effluent in a semi-industrial autonomous plant.

Science.gov (United States)

Expósito, Antonio J; Durán, Antonio; Monteagudo, José M; Acevedo, Alba

2016-05-01

An industrial wastewater effluent coming from a pharmaceutical laboratory has been treated in a semi-industrial autonomous solar compound parabolic collector (CPC) plant. A photo-Fenton process assisted with ferrioxalate has been used. Up to 79% of TOC can be removed in 2 h depending on initial conditions when treating an aqueous effluent containing up to 400 ppm of initial organic carbon concentration (TOC). An initial ratio of Fe(II)/TOC higher than 0.5 guarantees a high removal. It can be seen that most of TOC removal occurs early in the first hour of reaction. After this time, mineralization was very slow, although H2O2 was still present in solution. Indeed it decomposed to form oxygen in inefficient reactions. It is clear that remaining TOC was mainly due to the presence of acetates which are difficult to degrade. Copyright © 2016 Elsevier Ltd. All rights reserved.

Energy balance of the global photovoltaic (PV) industry--is the PV industry a net electricity producer?

Science.gov (United States)

Dale, Michael; Benson, Sally M

2013-04-02

A combination of declining costs and policy measures motivated by greenhouse gas (GHG) emissions reduction and energy security have driven rapid growth in the global installed capacity of solar photovoltaics (PV). This paper develops a number of unique data sets, namely the following: calculation of distribution of global capacity factor for PV deployment; meta-analysis of energy consumption in PV system manufacture and deployment; and documentation of reduction in energetic costs of PV system production. These data are used as input into a new net energy analysis of the global PV industry, as opposed to device level analysis. In addition, the paper introduces a new concept: a model tracking energetic costs of manufacturing and installing PV systems, including balance of system (BOS) components. The model is used to forecast electrical energy requirements to scale up the PV industry and determine the electricity balance of the global PV industry to 2020. Results suggest that the industry was a net consumer of electricity as recently as 2010. However, there is a >50% that in 2012 the PV industry is a net electricity provider and will "pay back" the electrical energy required for its early growth before 2020. Further reducing energetic costs of PV deployment will enable more rapid growth of the PV industry. There is also great potential to increase the capacity factor of PV deployment. These conclusions have a number of implications for R&D and deployment, including the following: monitoring of the energy embodied within PV systems; designing more efficient and durable systems; and deploying PV systems in locations that will achieve high capacity factors.

Importance of pharmaceutical laboratory compliance with international standard requirements in respect of raising their competitiveness

Directory of Open Access Journals (Sweden)

Božanić Vojislav N.

2009-01-01

Full Text Available Current Good Manufacturing Practice (cGMP being a legal regulation in developed countries will become a legal regulation in Republic of Serbia starting with March 2010. In this paper comparative analysis between requirements of standard ISO/IEC 17025 and requirements of cEU GMP is shown. Considering the fact that in Republic of Serbia no pharmaceutical industry laboratory has been accredited according to requirements of ISO/IEC 17025, while keeping in mind that more than 90% of these laboratories have not fulfilled cEU GMP requirements, this paper aimed at pointing to the possibility of fulfilling both of mentioned requirements at the same time, which would open the way to different types of interlaboratory cooperation for pharmaceutical quality control laboratories and contribute to improving competitiveness of pharmaceutical companies. Accreditation, especially in the case of pharmaceutical quality control laboratories, is important because it guaranties the level of organizational and technical competency. It could easily be said that accreditation is becoming a must in quality control of products in order for the organization to be able to gain a leading role in the global market. Both accreditation and cGMP show the organization's commitment to having products of highest quality level. Considering the above mentioned facts, it is of greatest advantage for pharmaceutical quality control laboratories to fulfill both requirements of ISO/IEC 17025 and cGMP and reach total compliance. The aim of doing this lies in an easier acceptance of pharmaceutical products in different markets, overcoming technical barriers and affirmation of quality as key factor in reaching competitiveness, while keeping in mind the importance of strategic and competitive positioning in the global market.

[PICS: pharmaceutical inspection cooperation scheme].

Science.gov (United States)

Morénas, J

2009-01-01

The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.

Industrial Upgrading in Global Production Networks: The Case of the Chinese Automotive Industry

OpenAIRE

Yansheng LI; Xin Xin KONG; Miao ZHANG

2015-01-01

This article examines the development of China’s automotive industry. The evidence shows that integration in global production networks has stimulated upgrading of technological capabilities among automotive firms. However, the competitiveness and intra-industry analyses show mixed results. Although intraindustry trade in automotive products has improved since 2000, the trade competitiveness of completely built up vehicles has largely remained in low value added activities. Nevertheless, firm...

The impact of globalization on the industrial growth of developing ...

African Journals Online (AJOL)

This paper is an attempt to investigate the impact of globalization on the industrial growth of developing economies with special reference to Nigeria. Globalization has facilitated the increased flow of ideas; people, goods and services across national frontiers. Some developing countries as a result of globalization have ...

Industrial global brand leadership : a capabilities view

NARCIS (Netherlands)

Beverland, M.; Napoli, J.; Lindgreen, A.

2007-01-01

We examine the global branding programs of five New Zealand industrial firms and identify the salient components and capabilities underpinning these programs. The cases built their respective brand identities around adaptability to customer needs and the provision of a total solution. This identity

Keeping modern in medicine: pharmaceutical promotion and physician education in postwar America.

Science.gov (United States)

Greene, Jeremy A; Podolsky, Scott H

2009-01-01

Recent critiques of the role of pharmaceutical promotion in medical practice invoke a nostalgic version of 1950s and 1960s medicine as representing an uncomplicated relationship between an innovative pharmaceutical industry and an idealistic and sovereign medical profession-a relationship that was later corrupted by regulatory or business practice changes in the 1980s or 1990s. However, the escalation of innovation and promotion in the pharmaceutical industry at mid-century had already provoked a broader crisis of overflow in medical education in which physicians came to use both commercial and professional sources in an attempt to "keep modern" by incorporating emerging therapeutics into their practices. This phenomenon was simultaneously a crisis for the medical profession- playing a key role in attempts to inculcate a "rational therapeutics"-and a marketing opportunity for the pharmaceutical industry, and produced the structural foundations for contemporary debates regarding the role of pharmaceutical promotion in medical practice. Tracing the issue from the advent of the wonder drugs through today's concerns regarding formal CME, we document how and why the pharmaceutical industry was allowed (and even encouraged) to develop and maintain the central role it now plays within postgraduate medical education and prescribing practice.

Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

Science.gov (United States)

Education Development Center, Inc., Newton, MA.

The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

MANAGING INDUSTRIAL PHARMACEUTICAL RESEARCH-AND-DEVELOPMENT - A COMPARATIVE-STUDY OF MANAGEMENT CONTROL AND INNOVATIVE EFFECTIVENESS IN EUROPEAN AND ANGLO-AMERICAN COMPANIES

NARCIS (Netherlands)

OMTA, SWF; BOUTER, LM; VANENGELEN, JML

1994-01-01

Drug regulation and pricing have put strong pressure on the cost-benefit ratio of the innovative pharmaceutical industry. Therefore a study has been conducted in fourteen large and medium sized companies to determine some important organisational and managerial factors influencing success in

Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials

Science.gov (United States)

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Background Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry–sponsored clinical trials and its evolution over time. Methods We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry–sponsored international trials. Results 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry–sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry–sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry–sponsored trials (from 42.4% to 37.2%). Conclusions Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry–sponsored clinical research. Only 3% of

Inherent Anticipation in the Pharmaceutical and Biotechnology Industries.

Science.gov (United States)

Goldman, Michael; Evans, Georgia; Zappia, Andrew

2015-04-15

Pharmaceutical and biotech research often involves discovering new properties of, or new methods to use, existing compositions. The doctrine of inherent anticipation, however, prevents the issuance and/or validity of a patent for discoveries deemed to have been implicitly disclosed in the prior art. This can be a barrier to patent rights in these technologies. Inherent anticipation therefore creates uncertainty for patent protection in the pharmaceutical and biotech sciences. Despite this uncertainty, Federal Circuit jurisprudence provides guidance on the boundaries of the inherent anticipation doctrine. In view of the case law, certain strategies may be employed to protect inventions that may potentially be viewed as inherent in the prior art. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

The role of the pharmaceutical industry in meeting the public health threat of antibacterial resistance.

Science.gov (United States)

Bergström, Richard

2011-04-01

The established market model for pharmaceutical products, as for most other products, is heavily dependent on sales volumes. Thus, it is a primary interest of the producer to sell large quantities. This may be questionable for medicinal products and probably most questionable for antibacterial remedies. For these products, treatment indications are very complex and encompass both potential patient benefits, possible adverse effects in the actual patient and, which is unique for this therapeutic class, consideration about what effects the drug use will have on the future therapeutic value of the drug. This is because bacteria are sure to develop resistance. The European Federation of Pharmaceutical Industries and Associations (EFPIA) agrees with the general description of the antibacterial resistance problem and wants to participate in measures to counteract antibacterial resistance. Stakeholders should forge an alliance that will address the need for and prudent use of new antibiotics. A variety of incentives probably have to be applied, but having all in common that the financial return has to be separated from the use of the product. Copyright © 2011. Published by Elsevier Ltd.

REASONS FOR JAPAN AND SOUTH KOREA AUTOMOBILE INDUSTRY GLOBAL SUCESS

OpenAIRE

Marek Rutka

2016-01-01

The article describes the story of both Japan and South Korean automotive industry development. Author points out the political, social and economical success factors of this branch in the global market. He also mentions major industry barriers which influen-tial the development of the automotive industry in both countries. Finally he presents the probable development perspectives for both Japan and South Korea automotive industry.

REASONS FOR JAPAN AND SOUTH KOREA AUTOMOBILE INDUSTRY GLOBAL SUCESS

Directory of Open Access Journals (Sweden)

Marek Rutka

2016-09-01

Full Text Available The article describes the story of both Japan and South Korean automotive industry development. Author points out the political, social and economical success factors of this branch in the global market. He also mentions major industry barriers which influen-tial the development of the automotive industry in both countries. Finally he presents the probable development perspectives for both Japan and South Korea automotive industry.

Actitud de los médicos frente a las prácticas de promoción de la industria farmacéutica The attitude of physicians regarding the promotion strategies of the pharmaceutical industry

Directory of Open Access Journals (Sweden)

Leonardo Castresana

2005-06-01

practices are commonly used, little has been published about the attitude of physicians concerning their interaction with the pharmaceutical industry. We performed a cross sectional anonymous survey to identify the extent of and attitudes towards the relationship between the physicians and the pharmaceutical industry and its representatives with its impact on the knowledge, attitude and behavior of the physicians. Internists, cardiologists and dermatologists who work in ambulatory settings from private and public hospitals in Buenos Aires city participated in this study, 44% were female, 35% residents, 65% staff physicians, averaging 41 years of age. Of these, 86% receive medical samples frecuently, 39% desk gifts, 19% invitations to congresses and 12% free lunches. Half of the doctors believe that receiving benefits from the pharmaceutical industry has an influence on medical prescription, but only 27% accept this as influential in their own prescriptions. Residents consider, more frequently than others, that these activities affect their decisions, (42% vs. 18% p = 0.007, global 30%. Most of the participants consider appropriate receiving these benefits, although 35% think that they affect the final price of medications. In conclusion, there is a high level of interaction between the pharmaceutical industry and our medical population. Although the latter recognize the influence of these interactions on prescriptions and the elevation of the cost of the final product, they find it appropriate to receive benefits.

Global alcohol policy and the alcohol industry.

Science.gov (United States)

Anderson, Peter

2009-05-01

The WHO is preparing its global strategy on alcohol, and, in so doing, has been asked to consult with the alcohol industry on ways it could contribute in reducing the harm done by alcohol. This review asks which is more effective in reducing harm: the regulatory approaches that the industry does not favour; or the educational approaches that it does favour. The current literature overwhelmingly finds that regulatory approaches (including those that manage the price, availability, and marketing of alcohol) reduce the risk of and the experience of alcohol-related harm, whereas educational approaches (including school-based education and public education campaigns) do not, with industry-funded education actually increasing the risk of harm. The alcohol industry should not be involved in making alcohol policy. Its involvement in implementing policy should be restricted to its role as a producer, distributor, and marketer of alcohol. In particular, the alcohol industry should not be involved in educational programmes, as such involvement could actually lead to an increase in harm.

The global methanol industry -- Is it deja vu all over again?

International Nuclear Information System (INIS)

Crocco, J.R.

1995-01-01

The author reviews the methanol industry in the 1980's and uses this to forecast the future of the industry, attempting to be as realistic as possible. Data are presented on the global methanol supply and demand, anticipated new methanol production capacity, and the 1995 worldwide methanol capacity. Although the global methanol industry, and most especially the producers, are entering some stormy seas, they are not completely uncharted. Those who were around ten or more years ago can see some similarities between current and anticipated market conditions. The similarities and differences are discussed

Laboratory and software applications for clinical trials: the global laboratory environment.

Science.gov (United States)

Briscoe, Chad

2011-11-01

The Applied Pharmaceutical Software Meeting is held annually. It is sponsored by The Boston Society, a not-for-profit organization that coordinates a series of meetings within the global pharmaceutical industry. The meeting generally focuses on laboratory applications, but in recent years has expanded to include some software applications for clinical trials. The 2011 meeting emphasized the global laboratory environment. Global clinical trials generate massive amounts of data in many locations that must be centralized and processed for efficient analysis. Thus, the meeting had a strong focus on establishing networks and systems for dealing with the computer infrastructure to support such environments. In addition to the globally installed laboratory information management system, electronic laboratory notebook and other traditional laboratory applications, cloud computing is quickly becoming the answer to provide efficient, inexpensive options for managing the large volumes of data and computing power, and thus it served as a central theme for the meeting.

Drivers of peak sales for pharmaceutical brands

NARCIS (Netherlands)

Fischer, Marc; Leeflang, Peter S. H.; Verhoef, Peter C.

2010-01-01

Peak sales are an important metric in the pharmaceutical industry. Specifically, managers are focused on the height-of-peak-sales and the time required achieving peak sales. We analyze how order of entry and quality affect the level of peak sales and the time-to-peak-sales of pharmaceutical brands.

Why regulatory indifference towards pharmaceutical pollution of the ...

African Journals Online (AJOL)

Unlike other environmental contaminants, pharmaceutical pollutants are not yet regulated globally, simply because acute risk assessments show insignificant human health hazard. But the pitfalls of pharmaceutical pollutants extend beyond acute effects to delayed effects from bioaccumulation, amplified effects from ...

The Applied Aspects of Transposition and Integration of Development Resources in the System of Strategic Management of the Pharmaceutical Industry Enterprises

Directory of Open Access Journals (Sweden)

Mykhailiuk Myroslava О.

2018-02-01

Full Text Available The article is aimed at researching the transposition and integration of development resources in the system of strategic management of pharmaceutical enterprises. It has been determined that in the current of market functioning, resources are transformed into development resources. The proposed scheme of transposition and integration of development resources in the system of strategic management of enterprises provides a combination of resource opportunities of company with market conditions and reflects synergistic interaction between two classical theories of strategic management: the M. Porter’s sectoral competition theory and the resource theory. The basic priorities of development of the pharmaceutical industry in the contemporary market environment are defined and trends of activity of pharmaceutical companies are indicated. Enterprises are distributed according to the criterion of introduction of development resources strategy, measures on increase of efficiency of their activity are suggested.

Modelling of drying processes of pharmaceutical granules. Pharmaceutical Sciences for the Future of Medicines

DEFF Research Database (Denmark)

Mortier, S.T.F.C.; Vedantam, S.; De Beer, T.

Tablets are conventionally produced via consecutive batch process steps. Recent introduction of continuous process equipment is gaining industrial importance in pharmaceutics. Transition to continuous production requires improved understanding of all operations, necessitating the development...... of mechanistic models of multi‐phase systems which in the end allow process control. This contribution focuses on continuous fluidized bed drying of pharmaceutical wet granules. A stepwise approach is used in model development, starting with the drying behaviour of single granules. Experiments to determine...

Global perspectives on ensuring the safety of pharmaceutical products in the distribution process
.

Science.gov (United States)

Jeong, Sohyun; Ji, Eunhee

2018-01-01

The distribution of counterfeit or falsified drugs is increasing worldwide. This can contribute to the high burden of disease and cost to society and is of global concern with the worldwide circulation of pharmaceuticals. The preparation and implementation of good distribution practice should be one of the most important aspects of ensuring safe drug circulation and administration. This research aimed to compare and analyze good distribution practice guidelines from advanced countries and international organizations, and to evaluate the status of the current good distribution practice guidelines in the world. Advanced pharmaceutical countries and international organizations, such as the World Health Organization, European Union, Pharmaceutical Inspection Co-operation Scheme, United States of America, Canada, and Australia, which have stable good distribution practice guidelines and public confidence, were included in the analysis. The World Health Organization and European Union guidelines are models for standardized good distribution practice for nations worldwide. The United States of America has a combination of four different series of distribution practices which have a unique structure and detailed content compared to those of other countries. The Canadian guidelines focus on temperature control during storage and transportation. The Australian guidelines apply to both classes of medicinal products and medical devices and need separate standardization. Transparent information about the Internet chain, international cooperation regarding counterfeiting, a high-standard qualification of sellers and customers, and technology to track and trace the whole life cycle of drugs should be the main focus of future good distribution practice guidelines worldwide.
.

Pharmaceutical Public-Private Partnerships

DEFF Research Database (Denmark)

Bagley, Constance; Tvarnø, Christina D.

2014-01-01

This article provides a game theory and law-and-management analysis of for- profit pharmaceutical public-private partnerships, a complex type of legal arrangement in the highly regulated pharmaceutical industry. A pharmaceutical public-private partnership (PPPP) agreement is a legally binding...... and a practical perspective on how properly crafted PPPP arrangements can promote innovation more efficiently than traditional self-optimizing contracts. In particular, a properly framed binding contract, coupled with respect for positive incentives, can move the parties away from an inefficient prisoners...... systems to build and share innovation. When coupled with appropriate attention to the difficult task of coordinating the actions of interdependent actors, a PPPP arrangement can enhance the likelihood of successful commercialization of pharmacological discoveries by flipping the par- ties’ incentives...

Computational Chemistry in the Pharmaceutical Industry: From Childhood to Adolescence.

Science.gov (United States)

Hillisch, Alexander; Heinrich, Nikolaus; Wild, Hanno

2015-12-01

Computational chemistry within the pharmaceutical industry has grown into a field that proactively contributes to many aspects of drug design, including target selection and lead identification and optimization. While methodological advancements have been key to this development, organizational developments have been crucial to our success as well. In particular, the interaction between computational and medicinal chemistry and the integration of computational chemistry into the entire drug discovery process have been invaluable. Over the past ten years we have shaped and developed a highly efficient computational chemistry group for small-molecule drug discovery at Bayer HealthCare that has significantly impacted the clinical development pipeline. In this article we describe the setup and tasks of the computational group and discuss external collaborations. We explain what we have found to be the most valuable and productive methods and discuss future directions for computational chemistry method development. We share this information with the hope of igniting interesting discussions around this topic. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

GLOBALIZATION AND THE COMPETITIVENESS OF THE EUROPEAN TEXTILE AND CLOTHING INDUSTRY

Directory of Open Access Journals (Sweden)

Girneata Adriana

2015-07-01

Full Text Available The aim of the paper is to analyze the competitiveness of the European textile and clothing industry under the influence of globalization and recent economic crisis. The textile and clothing industry is an important part of the European manufacturing industry, playing a vital role in the economy and social welfare in many regions of Europe. The European textile and clothing industry has undergone significant changes in recent decades due to the technological advances, developments in production costs, the emergence major international competitors and the elimination import quotas after 2005. In response to the competitive challenges, this sector of activity has undertaken a lengthy process of restructuring and modernization. Globalization and technological progress have led to rethinking the strategy of the companies in the industry. In a competitive global market, European organizations producing textiles and garments have as main competitive advantage research and continuous innovation. Using methods of qualitative research, this paper analyses the evolution of the main financial indicators concerning this sector of activity in the period 2007 – 2013, including domestic consumption, turnover, number of employees, number of companies, imports and exports. The globalization of markets, international outsourcing and development of the Internet had a major impact on the structure and dynamics of the textile and clothing industry in Europe, and in particular on small and medium enterprises. Also, relocation, subcontracting and outsourcing of large brands in this domain have contributed significantly to the increase of imports from low-cost countries. A growing number of apparel retailers have emerged on the market, organizing supply chains globally. At the same time, producers have transferred part of their activities to low-cost countries in order to maintain market competitiveness. This was determined by the major differences in salaries across

The Market of Biopharmaceutical Medicines: A Snapshot of a Diverse Industrial Landscape

Directory of Open Access Journals (Sweden)

Evelien Moorkens

2017-06-01

Full Text Available Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market.Objectives: This study aims to identify and document which investment and development strategies are adopted by industrial players in the global biopharmaceutical market.Methods: A descriptive analysis was undertaken of the investment and development strategies of the top 25 pharmaceutical companies according to 2015 worldwide prescription drug sales. Strategies were documented by collecting data on manufacturing plans, development programs, acquisition and collaboration agreements, the portfolio and pipeline of biosimilar, originator and next-generation biopharmaceutical products. Data were extracted from publicly available sources.Results: Various investment and development strategies can be identified in the global biopharmaceutical market: (a development of originator biopharmaceuticals, (b investment in biotechnology, (c development of next-generation biopharmaceuticals, (d development of biosimilars, (e investment in emerging countries, and (f collaboration between companies. In the top 25 pharmaceutical companies almost every company invests in originator biopharmaceuticals and in biotechnology in general, but only half of them develops next-generation biopharmaceuticals. Furthermore, only half of them invest in development of biosimilars. The companies' biosimilar pipeline is mainly focused on development of biosimilar monoclonal antibodies and to some extent on biosimilar insulins. A common strategy is collaboration between companies and investment in emerging countries.Conclusions: A snapshot of investment and development strategies used by industrial players in the global biopharmaceutical market shows that all top 25 pharmaceutical companies are engaged in the biopharmaceutical market and

The globalization of the arms industry: The next proliferation challenge

Energy Technology Data Exchange (ETDEWEB)

Bitzinger, R.A.

1994-12-31

The globalization of the arms industry entails a significant shift away from traditional, single-country patterns of weapons production toward internationalization of the development, production, and marketing of arms. While wholly indigenous armaments production may be on the decline, multinational arms production - through collaboration on individual weapon systems and increasingly via interfirm linkages across the international arms industry - appears actually to be expanding. In several instances, in fact, multinational armaments production is increasingly supplementing or even supplanting indigenous or autonomous weapons production or arms imports. The emergence of an increasingly transnational defense technology and industrial base is fundamentally affecting the shape and content of much of the global arms trade. This changing defense market, in turn, will have a profound impact on a number of national security issues concerning the Western industrialized nations. 3 figs., 2 tabs.

Pharmacist-industry relationships.

Science.gov (United States)

Saavedra, Keene; O'Connor, Bonnie; Fugh-Berman, Adriane

2017-12-01

The purpose of this study was to document, in their own words, beliefs and attitudes that American pharmacists have towards the pharmaceutical industry and pharmacists' interactions with industry. An ethnographic-style qualitative study was conducted utilizing open-ended interviews with four hospital pharmacists, two independent pharmacists, two retail pharmacists and one administrative pharmacist in the Washington, DC, metropolitan area to elicit descriptions of and attitudes towards pharmacists' relationships with industry. Analysis of the qualitative material followed established ethnographic conventions of narrative thematic analysis. All pharmacists reported interactions with pharmaceutical company representatives. Most had received free resources or services from industry, including educational courses. Respondents uniformly believed that industry promotional efforts are primarily directed towards physicians. Although respondents felt strongly that drug prices were excessive and that 'me-too' drugs were of limited use, they generally had a neutral-to-positive view of industry-funded adherence/compliance programmes, coupons, vouchers, and copay payment programmes. Interviewees viewed direct-to-consumer advertising negatively, but had a generally positive view of industry-funded drug information. Pharmacists may represent a hitherto under-identified cohort of health professionals who are targeted for industry influence; expanding roles for pharmacists may make them even more attractive targets for future industry attention. Pharmacy schools should ensure that students learn to rely on unbiased information sources and should teach students about conflicts of interest and the risks of interacting with industry. Further research should be conducted on the extent to which pharmacists' attitudes towards their duties and towards drug assessment and recommendation are influenced by the pharmaceutical industry. © 2017 Royal Pharmaceutical Society.

Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

Energy Technology Data Exchange (ETDEWEB)

Razem, D; Katusin-Razem, B [Institut Rudjer Boskovic, Zagreb (Yugoslavia); Starcevic, M; Galekovic, B [PLIVA Pharmaceutical Works, Zagreb (Yugoslavia)

1990-01-01

The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author).

Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

International Nuclear Information System (INIS)

Razem, D.; Katusin-Razem, B.; Starcevic, M.; Galekovic, B.

1990-01-01

The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author)

Integrating developing country manufacturing industries into global supply chain

Directory of Open Access Journals (Sweden)

Fasika Bete Georgise

2014-01-01

Full Text Available Purpose: Due to globalization of manufacturing activities, the arena of competition and competitiveness advantage is moving from firms towards supply chains and networks. With the recent advancement of information and communication technologies this participation are becoming as common business practice in developed countries firms. Companies were more integrated into the world market for the global nature of the sourcing, manufacturing and distribution. These changes create both challenges and opportunities for the manufacturing industries in developing countries. The objective of this paper is to examine the level of inter-organizational and intra-organizational supply chain integration practices in developing country, Ethiopia.Design/methodology/approach: An industrial questionnaires survey was used to collect the current practices of the manufacturing industries in Ethiopia as an example of the developing countries. Descriptive statistics is primarily used for the analysis.Findings: Results show a low level of supply chain relationship both in intra and inter organizational supply chain integration level among members. Accordingly, such issues require much attention to facilitate a greater integration within the supply chains in the Ethiopian manufacturing industries.Research limitations/implications: The paper focuses on examining the practices of Ethiopian manufacturing industries empirical data. The interpretation of results should be taken with prudence.Originality/Value: The manufacturing industry in developing countries (MIDC has been a part of the global supply chains for long time as a supplier of raw material and manufacturer of primary products. Currently, the MIDC is trying to access the different markets segment of the world even with new products starting from their local market to the complex and dynamic international market. Nevertheless, their supply chains are inefficient and hence, their competitiveness level far from the

A Future-Oriented, Globally Based Curriculum Model for Industrial Technology.

Science.gov (United States)

Hacker, Michael

1982-01-01

Presents a future-oriented curriculum approach for industrial technology programs. Major global issues provide the basic structure for curriculum development. These issues include energy management, resource management, technological advancement, and international relations. Rationales for industrial technology are discussed and a curriculum…

Marketing and Globalization of the Brewing Industry

DEFF Research Database (Denmark)

Madsen, Erik Strøjer; Wu, Yanqing

2016-01-01

The globalization of the brewing industry after the turn of the century through a large wave of mergers and acquisitions has changed the structure of the world beer markets. The chapter tracks the development in industry concentrations from 2002 to 2012 and points to high transportation costs...... for beers and economies of scale at the firm level in advertising and sales efforts as the main factors behind the wave of cross-country mergers and acquisitions. Using firm-level data from the largest breweries, the estimations verify significant economies of scale at the firm level in marketing...... significant economies of scale benefits at the firm level to be shared between the merging partners as marketing and distribution costs are very high in this industry....

Health risks of counterfeit pharmaceuticals.

Science.gov (United States)

ten Ham, Martijn

2003-01-01

Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate.

Desafios da química analítica frente às necessidades da indústria farmacêutica Challenges of analytical chemistry in face of the needs of the pharmaceutical industry

Directory of Open Access Journals (Sweden)

Alberto dos Santos Pereira

2005-12-01

Full Text Available 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. In different segments of Brazilian Industry mass spectrometry has an important role, e.g. in the pharmaceutical industry in the development of generic formulations, contributing to the growth of Industry and social inclusion. However, the Brazilian chemists until this moment don't have an effective role in this new segment of the analytical chemistry in Brazil. The present paper shows the actual scenario for mass spectrometry in the pharmaceutical industry, emphasizing the need of a revision of graduation courses to attend the needs of this growing market.

Integrating systems Approaches into Pharmaceutical Sciences

DEFF Research Database (Denmark)

Westerhoff, H.V.; Mosekilde, Erik; Noe, C. R.

2008-01-01

During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose...... of the conference was to promote the ‘Integration of Systems Approaches into Pharmaceutical Sciences’ in view of optimising the development of new effective drugs. And a challenge this is, considering both the high attrition rates in the pharmaceutical industry and the failure of finding definitive drug solutions...... for many of the diseases that plague mankind today. The conference was co-sponsored by the American College of Clinical Pharmacology, the European Center for Pharmaceutical Medicine, and the Swiss Society of Pharmaceutical Sciences and, besides representatives from the European Regulatory Agencies and FDA...

Elimination of micropollutants and hazardous substances at the source in the chemical and pharmaceutical industry.

Science.gov (United States)

Blöcher, C

2007-01-01

Industrial wastewater, especially from chemical and pharmaceutical production, often contains substances that need to be eliminated before being discharged into a biological treatment plant and following water bodies. This can be done within the production itself, in selected waste water streams or in a central treatment plant. Each of these approaches has certain advantages and disadvantages. Furthermore, a variety of wastewater treatment processes exist that can be applied at each stage, making it a challenging task to choose the best one in economic and ecological terms. In this work a general approach for that and examples from practice are discussed.

Determining supply chain management trends in the pharmaceutical industry / Mokgokong ElizabethTsoku

OpenAIRE

Tsoku, Mokgokong Elizabeth

2014-01-01

For quality service, business management is continually evolving. This also applies to pharmaceutical business management from manufacturing to distribution and retail pharmacies. The main problem being faced is to work on the demand and supply challenges that are being faced by the pharmaceutical businesses and to build and optimize supply chain management in pharmaceutical business in South Africa. The main objective of this study sets to evaluate whether supply chain tren...

Supply Network Planning for New Product Market Entry in the Pharmaceutical Industry

DEFF Research Database (Denmark)

Hansen, Klaus Reinholdt Nyhuus; Grunow, Martin

2011-01-01

uncertainty and the risk of a forced label change and includes solution robustness. While considering limited shelf life of the drug, the supply of packaging material and outsourcing, the objective of our model is to reduce supply chain cost including lost peak sales from delayed market entry....... planning before and during the market entry of the drug after the drug has been approved. Production of the active pharmaceutical ingredient [API] is characterized by long change-over times due to cleaning requirements. Production planning is long term, multiple batches of each drug are produced...... industry, reimbursement negotiations have to be carried out before a drug can be marketed. These negotiations both necessitate time phasing market entries and introduce a series of uncertainties e.g. varying allowed price and awarded subsidy. Also if the label is not approved for marketing, all packaged...

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

Directory of Open Access Journals (Sweden)

Lončar Irma M.

2013-01-01

Full Text Available 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 conducted: 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% quality on the packaging of drugs 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 them (86.9% know, its function, but majority (60.2% would nevertheless decide to buy the drug without KM. Regarding the experts from the pharmaceutical industry, more then two-thirds of them (68.4% believed that the existence of KM did not contribute to efficient operations. Although a great number of pharmaceutical industry professionals (84.2% answered 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 domestic 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 satisfied 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

Drugs for cardiovascular disease in India: perspectives of pharmaceutical executives and government officials on access and development-a qualitative analysis.

Science.gov (United States)

Newman, Charles; Ajay, Vamadevan S; Srinivas, Ravi; Bhalla, Sandeep; Prabhakaran, Dorairaj; Banerjee, Amitava

2016-01-01

India shoulders the greatest global burden of cardiovascular diseases (CVDs), which are the leading cause of mortality worldwide. Drugs are the bedrock of treatment and prevention of CVD. India's pharmaceutical industry is the third largest, by volume, globally, but access to CVD drugs in India is poor. There is a lack of qualitative data from government and pharmaceutical sectors regarding CVD drug development and access in India. By purposive sampling, we recruited either Indian government officials, or pharmaceutical company executives. We conducted a stakeholder analysis via semi-structured, face-to-face interviews in India. Topic guides allow for the exploration of key issues across multiple interviews, along with affording the interviewer the flexibility to examine matters arising from the discussions themselves. After transcription, interviews underwent inductive thematic analysis. Ten participants were interviewed (Government Officials: n = 5, and Pharmaceutical Executives: n = 5). Two themes emerged: i) 'Policy-derived Factors'; ii) 'Patient- derived Factors' with three findings. First, both government and pharmaceutical participants felt that the focus of Indian pharma is shifting to more complex, high-quality generics and to new drug development, but production of generic drugs rather than new molecular entities will remain a major activity. Second, current trial regulations in India may restrict India's potential role in the future development of CVD drugs. Third, it is likely that the Indian government will tighten its intellectual property regime in future, with potentially far-reaching implications on CVD drug development and access. Our stakeholder analysis provides some support for present patent regulations, whilst suggesting areas for further research in order to inform future policy decisions regarding CVD drug development and availability. Whilst interviewees suggested government policy plays an important role in shaping the industry, a

PARTICULARITIES OF MODERN PHARMACEUTICAL PROMOTION

Directory of Open Access Journals (Sweden)

Юрий Владимирович Тарасов

2014-02-01

Full Text Available Pharmaceutical products market is one of the most saturated consumers’ markets. Characteristic features of it are: high competition, fierce struggle for the customer, specific technologies of promotion. In conditions of globalization and increase in competition both in world pharmaceutical market and in the market of medicines and goods of medical purpose in Russia modern marketing techniques of promotion of the products to the end consumers are the key tools for strengthening market positions – both of producers of pharmaceutical goods and their suppliers, distributors, big whole-sale companies. Among main tools of promotion are: advertising, public relations, stimulation of sales on the market of medicines, personal sales, computer technologies. The article describes different technologies of promotion of medicines: indoor-advertising, hot lines, pharmaceutical exhibitions, packing. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-1

The formation of the global natural gas industry: definition, constraints and challenges; A formacao da industria global de gas natural: definicao, condicionantes e desafios

Energy Technology Data Exchange (ETDEWEB)

Mathias, Melissa Cristina Pinto Pires

2008-03-15

This study aims to investigate the real possibilities for the natural gas industry to become a global energy industry. So, it is necessary to define what global energy industry really means. In order to do a comparative analysis between the oil and natural gas industries, it is necessary to define three distinct stages of the evolution of an energy industry, namely internationalization, mundialization and globalization. This study analyzes the evolution of the oil industry trying to identify the main aspects that promoted changes and transformed the oil business into a global industry. Then, the evolution of the natural gas industry is analyzed, looking for similarities between the structural changes in both industries, and trying to determine what is the current stage of the natural gas industry. Despite the increase in the natural gas international trade and the prospects of growth of natural gas demand, there are still some challenges for this industry to effectively become global. Some of the challenges are the need of investments in production infrastructure, transportation and distribution sectors, the access to the main reserves, the uncertainty related to the demand evolution and the possible creation of a natural gas producers cartel, like the Organization of the Petroleum Exporting Countries (OPEC). (author)

Normas para la publicación de investigaciones clínicas patrocinadas por la industria farmacéutica Publication standards for clinical research sponsored by the pharmaceutical industry

Directory of Open Access Journals (Sweden)

2003-07-01

Full Text Available The role played by the private sector, in particular the pharmaceutical industry, in funding research has been growing at an accelerated pace in recent decades. So much so, in fact, that the private sector has become the primary funding source of clinical trials in some countries. As a result, pharmaceutical companies exercise ever-growing control over not only the design of clinical trials but also the publication of their results. The conflicts of interest involved in this kind of situation can lead to ethical breaches (for example, suppression or distortion of results or the intimidation of investigators, and it is crucial to take concrete steps to guard against such breaches. This is exactly what a Working Group made up of members of the pharmaceutical industry itself has done, preparing a series of guidelines for that industry in order to promote good publication practices. These guidelines, which were just recently published in English, represent an important step in efforts to achieve greater transparency and accountability in the presentation of results of research funded by manufacturers of pharmaceutical products. Although the guidelines, now translated into Spanish in this piece, are subject to future revisions, they are a valuable starting point for further discussion of a problem that deserves the urgent attention of the scientific community.

Spatial lifecycles of cleantech industries – The global development history of solar photovoltaics

International Nuclear Information System (INIS)

Binz, Christian; Tang, Tian; Huenteler, Joern

2017-01-01

New industries develop in increasingly globalized networks, whose dynamics are not well understood by academia and policy making. Solar photovoltaics (PV) are a case in point for an industry that experienced several shifts in its spatial organization over a short period of time. A lively debate has recently emerged on whether the spatial dynamics in new cleantech sectors are in line with existing industry lifecycle models or whether globalization created new lifecycle patterns that are not fully explained in the literature. This paper addresses this question based on an extensive analysis of quantitative data in the solar PV sector. Comprehensive global databases containing 86,000 patents as well as manufacturing and sales records are used to analyze geographic shifts in the PV sector’s innovation, manufacturing and market deployment activities between 1990 and 2012. The analysis reveals spatial lifecycle patterns with lower-than-expected first mover advantages in manufacturing and market activities and an earlier entry of firms from emerging economies in manufacturing and knowledge creation. We discuss implications of these findings for the competitive positions of companies in developed and emerging economies, derive new stylized hypotheses for industry lifecycle theories, and sketch policy approaches that are reflexive of global interdependencies in emerging cleantech industries. - Highlights: • The global spatial lifecycle of the solar photovoltaic (PV) industry is analyzed. • Our data partly contradicts existing industry lifecycle theories. • Latecomers in China started manufacturing and deployment earlier than expected. • Pioneers in the US and EU retained significant first-mover advantages in patenting. • Industry lifecycle theory needs updates in the production and market dimensions.

Characterization of the evolution of the pharmaceutical regulatory environment.

Science.gov (United States)

Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

2013-01-01

This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

Perception and application of the concept “quality by design” (QbD) by the pharmaceutical industry in Portugal

OpenAIRE

Garcia, Ana Cristina; Fernandes, Paula O.; Santos, Andreia

2014-01-01

The Quality by Design (QbD) paradigm states that in order to ensure predefined product quality, improve manufacturing quality performance, and serve customers’ needs one must fully understand the processes behind it. With the purpose of assessing the perception of the pharmaceutical industry in Portugal about the usefulness of a strategy for development, production optimization and control/quality management according to the QbD concept and its level of implementation, we conducted a survey a...

Competing in the Global Solar Photovoltaic Industry: The Case of Taiwan

Directory of Open Access Journals (Sweden)

Yu-Shan Su

2013-01-01

Full Text Available The top five solar cell supply countries in the world in sequential order are China, Taiwan, the United States of America, Japan, and Germany. The capacity of Taiwanese solar cell production is ranked top two in the globe. The competitive advantage of the Taiwanese electronics firms has facilitated the rapid developments to its solar photovoltaic industry. The Taiwanese solar photovoltaic industry possesses a large size and a complete value chain of upstream, midstream, and downstream sectors. In this study, I analyzed the trends and developments of the solar photovoltaic industry in Taiwan and in the globe. And I also investigated the positioning and competitive advantage of Taiwanese firms in the value chain of the global solar photovoltaic industry. I found that Taiwanese firms continue to have an important and indispensable role in the global solar photovoltaic industry by either differentiation or cost advantage.

The emerging role of MD Pharmacology postgraduate in pharmaceutical industry

OpenAIRE

Pratishtha Banga Chaudhari

2016-01-01

Patient-benefit is a shared goal of the pharmaceutical company and the treating doctor. At the same time, the pharmaceutical company- in order to recur its R and D costs has to balance patient centricity with making profits. Consequently, the commercial benefits from prescription of a product and education about optimal use of product both become the responsibilities of same organization. This often leads to allegations of bias by the regulators. We are in an era where regulatory bodies close...

Chemometrics-based process analytical technology (PAT) tools: applications and adaptation in pharmaceutical and biopharmaceutical industries.

Science.gov (United States)

Challa, Shruthi; Potumarthi, Ravichandra

2013-01-01

Process analytical technology (PAT) is used to monitor and control critical process parameters in raw materials and in-process products to maintain the critical quality attributes and build quality into the product. Process analytical technology can be successfully implemented in pharmaceutical and biopharmaceutical industries not only to impart quality into the products but also to prevent out-of-specifications and improve the productivity. PAT implementation eliminates the drawbacks of traditional methods which involves excessive sampling and facilitates rapid testing through direct sampling without any destruction of sample. However, to successfully adapt PAT tools into pharmaceutical and biopharmaceutical environment, thorough understanding of the process is needed along with mathematical and statistical tools to analyze large multidimensional spectral data generated by PAT tools. Chemometrics is a chemical discipline which incorporates both statistical and mathematical methods to obtain and analyze relevant information from PAT spectral tools. Applications of commonly used PAT tools in combination with appropriate chemometric method along with their advantages and working principle are discussed. Finally, systematic application of PAT tools in biopharmaceutical environment to control critical process parameters for achieving product quality is diagrammatically represented.

Developing global health technology standards: what can other industries teach us?

Science.gov (United States)

Masum, Hassan; Lackman, Rebecca; Bartleson, Karen

2013-10-17

There is a lack of effective and affordable technologies to address health needs in the developing world. One way to address problems of innovation and affordability is to design global health technologies to follow agreed-upon standards. This Debate article argues that we can better develop standards for global health technologies if we learn lessons from other industries. The article's Background section begins by explaining why standards are needed in global health. For example, if global health technologies can be modularized into independent interfacing parts, these parts can then interact via well-defined standards in a "plug and play" fashion. This can avoid development of mutually incompatible solutions by different organizations, speed the pace of innovation, unlock health systems from single providers and approaches, and lower barriers to entry. The Background then gives a brief primer on standards and discusses incentives for health standards. The article's Discussion section begins with brief relevant cases of standards development from other industries, including electricity, container shipping, CD standards, Universal Serial Bus (USB), and the Internet. It then explores lessons from these and other industries that suggest how to develop standards for global health technologies. The remainder of the Discussion considers intellectual property and regulatory issues and standards-based global health business models, and ends with a checklist of considerations for health standards development leaders. (The associated Additional file discusses observations from standards development for cell phones and semiconductors, as well as challenges in the standards development process itself.) Throughout the article, point-of-care diagnostics are used as an illustrative example. An initiative is already underway to explore standardized diagnostics platforms. This Debate article aims to convince the reader that standards can benefit global health technologies if we

The pharmaceutical quality revolution

Directory of Open Access Journals (Sweden)

Jordi Botet

2016-01-01

Full Text Available Pharmaceutical products are patient-oriented. If they had a deficient quality they might put live at risk. Ensuring their quality is not, however, a straightforward task and this is why different approaches have been used along the way. This article analyzes them and shows how our present approach, if well implemented, is very effective in ensuring quality.Methods. This article analyzes the current pharmaceutical quality system as described by international guidances in the light of practical experience gathered by the author as an international GMP-consultant.Result. Nowadays we have come to understand that as quality is a global concept in terms of time and of requirements, it has to be assured in a global way too. This is why quality assurance is a permanent process that starts during the development of a product and goes on during its manufacturing life. Manufacturing should be performed within a pharmaceutical quality system which ensures GMP compliance. Decisions should be science and risk-based. Products and processes are monitored by means of critical variables.Conclusions. The approach followed in the 21st century for ensuring quality is very effective and allows for a progressive reduction of the level of quality risk. However, this quality system is either comprehensive or there is no quality

[Early achievements of the Danish pharmaceutical industry--8. Lundbeck].

Science.gov (United States)

Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

2016-01-01

The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 8 deals with products from Lundbeck. Lundbeck which today is known as a considerable international pharmaceutical company could in 2015 celebrate its 100 years' jubilee. Among the early Danish medicinal companies H. Lundbeck & Co. is in many ways an exception as the company was not originally established as a pharmaceutical company. Not until several years after the foundation the company began to import foreign ready-made medicinal products and later-on to manufacture these medicinal products in own factory and even later to do research and development of own innovative products. When Lundbeck was established in 1915 several Danish medicinal companies, not only the well-known such as Alfred Benzon and Løvens kemiske Fabrik (LEO Pharma), but also Skelskør Frugtplantage, Ferrin and Ferraton, had emerged due to the respective enterprising pharmacy owners who had expanded their traditional pharmacy business and even with commercial success. Other medicinal companies, such as C.R. Evers & Co., Leerbeck & Holms kemiske Fabriker, Chr. F. Petri, Erslevs kemiske Laboratorium, Edward Jacobsen, Th. Fallesen-Schmidt, and yet other companies which were named after the founder had all been established by pharmacists with the primary intention to manufacture and sell medicinal products. Also for the limited companies Medicinalco, Ferrosan, Pharmacia, and GEA the primary task was to manufacture and sell medicinal products, and also in these companies pharmacists were involved in the foundation. Not until 1924, fully 9 years after the foundation, Lundbeck started to be interested in medicinal products and initiated import and sale of foreign medicinal products manufactured by a.o. German and French companies which had not established their own sales companies in Denmark. Almost all contemporary Danish manufacturers of

[Attitudes of general practitioners to pharmaceutical sales representatives in Sousse].

Science.gov (United States)

Ben Abdelaziz, A; Harrabi, I; Rahmani, S; Ghedira, A; Gaha, K; Ghannem, H

2003-01-01

The therapeutic knowledge of physicians is the corner stone to the rational use of medicines; however information about medicines is generally obtained from the pharmaceutical industry via their sales representatives (reps). We aimed to identify general practitioners' (GPs) attitudes to pharmaceutical reps and the information they provide. We surveyed 140 GPs using a self-administered questionnaire. The response rate was 78% (72 GPs from the public sector and 68 from the private sector). About 10% of the GPs said they received daily visits from pharmaceutical reps; 84% of GPs considered them an efficient source of information and 31% said they might change their therapeutic prescribing following visits from these reps. Because of their positive perception of pharmaceutical reps, GPs are susceptible to the information they provide. Controlling the validity of the therapeutic information imparted by the pharmaceutical industry is thus a fundamental component of the programme for the rational use of medicines.

New product testing and the utilization of user expertise: Evidence from the Pharmaceutical industry

DEFF Research Database (Denmark)

Smed, Marie; Salomo, Søren; Schultz, Carsten

2012-01-01

A significant and often neglected obstacle in new product development is the testing and approval process in the late stages of development. The testing process has primarily been observed as an in-house decision process, however, in many industries products undergo extensive testing before marke....... Further, with a dispersed user network a positive effect is observed on the mean to communicate directly as issues occur. The effect of virtual communication is therefore stronger than traditional face-to-face interaction patterns.......A significant and often neglected obstacle in new product development is the testing and approval process in the late stages of development. The testing process has primarily been observed as an in-house decision process, however, in many industries products undergo extensive testing before market...... the knowledge generated and shared by medical sites and Pharmaceutical producers in late stage product development. The results show, that information regarding usage patterns and product related services are more difficult to transfer between user and developer, than issues directly related to the product...

Penicillin dust exposure and penicillin resistance among pharmaceutical workers in Tehran, Iran.

Science.gov (United States)

Farshad, Ali Asghar; Enferadi, Mojtaba; Bakand, Shahnaz; Jamshidi Orak, Rouhangiz; Mirkazemi, Roksana

2016-07-01

Antimicrobial resistance (AMR) adversely impacts the prevention and treatment of a wide range of infections and is considered as a serious threat to global public health. Occupational-related AMR is a neglected area of research. To assess exposure to penicillin dust, penicillin active materials, and to report the frequency of penicillin resistance among pharmaceutical workers in Tehran, Iran. A quasi-experimental study was conducted among workers on a penicillin production line in a pharmaceutical company (n = 60) and workers in a food producing company (n = 60). Data were collected via survey, air sampling, and throat swab. The mean overall concentrations of penicillin dust and penicillin active material were 6.6 and 4.3 mg/m 3 , respectively, in the pharmaceutical industry. Streptococcus pneumoniae (S. pneumoniae) was detected in 45% (27) individuals in the exposed group, 92.6% of which showed penicillin resistance. Resistance was significantly higher among workers in penicillin production line (p = 0.014). High level of AMR among workers in penicillin production line is a health risk for the workers as well as society as a whole through the spread of drug resistant micro-organisms.

The role of bioethics in the international prescription drug market: economics and global justice.

Science.gov (United States)

Newland, Shelby E

2006-01-01

In terms of health care access, bioethics has an important role to inform and shape policy issues and develop interdisciplinary ideas and interventions. The rising price of prescription drugs presents one of the most looming barriers to health care access in the world today. Including both theoretical and practical features of the pharmaceutical industry's behavior is necessary to find ethical solutions towards increasing access. Bioethics can evaluate global justice by weighing human rights theory and future innovation at the macro level, and by addressing market forces and responsibilities at the micro level. Inherent structural features of pharmaceuticals, such as its reliance on research and development, cause the industry to employ pricing strategies that seem counter-intuitive to conventional wisdom, but that result in producing a just allocation as defined by market forces. Parallel trade and drug exportation/reimportation threaten the saliency of the industry's differential pricing scheme; a case-study of a single "Euro-price" within the European Union illustrates how this will actually create harm to the most needy member states. This complex situation requires solutions weighing arguments from human rights theory with those from economic theory to arrive at the most globally just allocation of prescription drugs in the global marketplace, as well as to ensure future innovation and scientific progress. Bioethicists as well as economists need to partake urgently in this discourse for the betterment of the global injustices in the international prescription drug market.

Global trends in milk quality: implications for the irish dairy industry

Directory of Open Access Journals (Sweden)

More SJ

2009-04-01

Full Text Available Abstract The quality of Irish agricultural product will become increasingly important with the ongoing liberalisation of international trade. This paper presents a review of the global and Irish dairy industries; considers the impact of milk quality on farm profitability, food processing and human health, examines global trends in quality; and explores several models that are successfully being used to tackle milk quality concerns. There is a growing global demand for dairy products, fuelled in part by growing consumer wealth in developing countries. Global dairy trade represents only 6.2% of global production and demand currently outstrips supply. Although the Irish dairy industry is small by global standards, approximately 85% of annual production is exported annually. It is also the world's largest producer of powdered infant formula. Milk quality has an impact on human health, milk processing and on-farm profitability. Somatic cell count (SCC is a key measure of milk quality, with a SCC not exceeding 400,000 cells/ml (the EU milk quality standard generally accepted as the international export standard. There have been ongoing improvements in milk quality among both established and emerging international suppliers. A number of countries have developed successful industry-led models to tackle milk quality concerns. Based on international experiences, it is likely that problems with effective translation of knowledge to practice, rather than incomplete knowledge per se, are the more important constraints to national progress towards improved milk quality.

Supply chain security orientation in the pharmaceutical industry ...

African Journals Online (AJOL)

Supply chain security orientation is an abstract phenomenon, which, up to now, has received little research attention. The purpose of this study, therefore, was to explore the supply chain security orientation of firms participating in the South African pharmaceutical supply chain with the aim of identifying specific risks and of ...

Strategic Management of Innovations at Pharmaceutical Enterprises

Directory of Open Access Journals (Sweden)

Honcharova Svіtlana Yu.

2014-01-01

Full Text Available The article is devoted to theoretical and practical issues of the use of the concept of strategic management of innovations at pharmaceutical enterprises. It studies main barriers, which restrict development of Ukrainian pharmaceutical enterprises. It analyses the state and tendencies of development of innovation activity of pharmaceutical enterprises and studies foreign experience of innovation activity. It marks out specific features of strategic management of innovation development in pharmaceutical industry. It specifies the role and advantages of methods of strategic analysis in the system of management of a pharmaceutical enterprise. It considers the essence of “innovation development” and “innovation model of development” notions and analyses their organisational and legal provision. It justifies strategic tasks of the pharmaceutical filed to focus on in order to achieve a breakthrough when building an innovation model of economic development. The article proves that the most important factors that ensure growth of efficiency of pharmaceutical production are: wide application of the concept of strategic management and creation of innovations.

Anaerobic manganese- or iron-mediated pharmaceutical degradation in water

NARCIS (Netherlands)

Liu, Wenbo

2018-01-01

Pharmaceutical compounds, originating mainly from industrial production and public consumption, are detected at extremely low levels (ng·L-1 –µg·L-1) in groundwater, surface water, and wastewater. So far, the adverse effects of pharmaceuticals and their intermediates have been widely reported,

Pharmaceutical product development: A quality by design approach

Science.gov (United States)

Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

Pharmaceutical product development: A quality by design approach.

Science.gov (United States)

Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

2016-01-01