When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

The global pharmaceutical industry is currently estimated to be worth $1 trillion. Contributors chart the rise of scientific marketing within the industry from 1920-1980. This is the first comprehensive study into pharmaceutical marketing, demonstrating that many new techniques were actually developed in Europe before being exported to America.

Many argue that the sole viable future for the automobile industry - indeed for all industry - is the adoption of `lean production' as an organizational model. One Best Way? brings together the research of academic specialists in the automobile industry who have analysed the evolution of 15 major Asian, North American, and European companies in terms of their technological, organizational, commercial and social `trajectories'. They look closely at the evidence for `one best way' and argue that it is more useful to assess the distinctive challenges and `trajectories' that companies have pursued as they try to optimize their profit-making capacities. The book present detailed descriptions of the major producers around the world in three sections: Asia: Toyota, Nissan, Honda, Mitsubishi, Hyundai North America: General Motors, Ford, Chrysler Europe: Peugeot, Renault, Rover, Mercedes, Volvo, Lada The book will be essential reading and reference for academics, researchers, and analysts worldwide wanting to track the course of the automobile industry and assess the merits of `lean production'.

Plants require nutrients in order to grow, develop and complete their life cycle. Mineral fertilizers, and hence the fertilizer industry, constitute one of the most imp- tant keys to the world food supplies. There is growing concern about the safety and quality of food. Carbon, hydrogen and oxygen, which, together with nitrogen, form the structural matter in plants, are freely available from air and water. Nitrogen, phosphorus and potassium, on the other hand, may not be present in quantities or forms sufficient to support plant growth. In this case, the absence of these nut- ents constitutes a limiting factor. The supply of nutrients to the plants should be balanced in order to maximise the efficiency of the individual nutrients so that these meet the needs of the particular crop and soil type. For example, it should be noted that EU-wide regulations are not designed to govern the specific details of mineral fertilizer use. Although plants receive a natural supply of nitrogen, phosphorus and potassium from organic matter and soil minerals, this is not usually sufficient to satisfy the demands of crop plants. The supply of nutrients must therefore be supplemented with fertilizers, both to meet the requirements of crops during periods of plant growth and to replenish soil reserves after the crop has been harvested. Pesticides are important in modern farming and will remain indispensable for the foreseeable future.

The mood of the international grain market changed remarkably in the decade before this book was originally published in 1986. In the early 1970s, which were years of buoyancy and high prices, the concern was with feeding the starving millions and subsequently, in the United states, with the use of the grain embargo weapon to put pressure on the Soviet Union. In the mid-1980s, after a long period in which the recession kept prices down, the climate was much gloomier. The book considers the state of the major supplier countries and their particular problems. It charts the changes in the market and discusses major issues of international concern. It concludes by surveying prospects for the market.

In this timely title Professor Arti Rai brings together a wide range of articles that reveal the important role of intellectual property law in the formation and development of the dynamic and economically significant biotechnology industry. The collection encompasses theoretical articles that present principles of patent economics important to the industry, articles that discuss the patent law doctrines most relevant to biotechnology and empirical studies on the 'real world' effects of patents and secrecy. These are resonant issues in an ever-expanding field, and will establish this book as an essential reference point for lawyers, researchers and students.

Coffee Culture: Local experiences, Global Connections explores coffee as (1) a major commodity that shapes the lives of millions of people; (2) a product with a dramatic history; (3) a beverage with multiple meanings and uses (energizer, comfort food, addiction, flavouring, and confection); (4) an inspiration for humor and cultural critique; (5) a crop that can help protect biodiversity yet also threaten the environment; (6) a health risk and a health food; and (7) a focus of alternative trade efforts. This book presents coffee as a commodity that ties the world together, from the coffee producers and pickers who tend the plantations in tropical nations, to the middlemen and processors, to the consumers who drink coffee without ever having to think about how the drink reached their hands.

Coffee: A Comprehensive Guide to the Bean, the Beverage, and the Industry offers a definitive guide to the many rich dimensions of the bean and the beverage around the world. Leading experts from business and academia consider coffee's history, global spread, cultivation, preparation, marketing, and the environmental and social issues surrounding it today. They discuss, for example, the impact of globalization; the many definitions of organic, direct trade, and fair trade; the health of female farmers; the relationships among shade, birds, and coffee; roasting as an art and a science; and where profits are made in the commodity chain. Drawing on interviews and the lives of people working in the business-from pickers and roasters to coffee bar owners and consumers-this book brings a compelling human side to the story. The authors avoid romanticizing or demonizing any group in the business. They consider basic but widely misunderstood issues such as who adds value to the bean, the constraints of peasant life, and the impact of climate change. Moving beyond simple answers, they represent various participants in the supply chain and a range of opinions about problems and suggested solutions in the industry. Coffee offers a multidimensional examination of a deceptively everyday but extremely complex commodity that remains at the center of many millions of lives. Tracing coffee's journey from field to cup, this handbook to one of the world's favorite beverages is an essential guide for professionals, coffee lovers, and students alike. Contributions by: Sarah Allen, Jonathan D. Baker, Peter S. Baker, Jonathan Wesley Bell, Clare Benfield, H. C. "Skip" Bittenbender, Connie Blumhardt, Willem Boot, Carlos H. J. Brando, August Burns, Luis Alberto Cuellar, Olga Cuellar, Kenneth Davids, Jim Fadden, Elijah K. Gichuru, Jeremy Haggar, Andrew Hetzel, George Howell, Juliana Jaramillo, Phyllis Johnson, Lawrence W. Jones, Alf Kramer, Ted Lingle, Stuart McCook, Michelle Craig McDonald, Sunalini Menon, Jonathan Morris, Joan Obra, Price Peterson, Rick Peyser, Sergii Reminny, Paul Rice, Robert Rice, Carlos Saenz, Vincenzo Sandalj, Jinap Selamat, Colin Smith, Shawn Steiman, Robert W. Thurston, Steven Topik, Tatsushi Ueshima, Camilla C. Valeur, Geoff Watts, and Britta Zeitemann

Weaving as a subject is an integral part of any textile engineering/technology program, the others being fibre manufacturing, yarn manufacturing and textile chemical processing. This book amalgamates both the compartments (preparatory processes and the loom mechanism) of weaving technology and presents a holistic picture. The machine descriptions are presented from the viewpoint of principles and no attempt has been made to make them exhaustive by incorporating various models or variants. The mathematical relations among various parameters have been derived starting from the first principles and each chapter concludes with solved numerical examples.

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

This book explores connections between activist debates about food sovereignty and academic debates about alternative food networks. The ethnographic case studies demonstrate how divergent histories and geographies of people-in-place open up or close off possibilities for alternative/sovereign food spaces, illustrating the globally uneven and varied development of industrial capitalist food networks and of everyday forms of subversion and accommodation. How, for example, do relations between alternative food networks and mainstream industrial capitalist food networks differ in places with contrasting histories of land appropriation, trade, governance and consumer identities to those in Europe and non-indigenous spaces of New Zealand or the United States? How do indigenous populations negotiate between maintaining a sense of moral connectedness to their agri- and acqua-cultural landscapes and subverting, or indeed appropriating, industrial capitalist approaches to food? By delving into the histories, geographies and everyday worlds of (post)colonial peoples, the book shows how colonial power relations of the past and present create more opportunities for some alternative producer-consumer and state-market-civil society relations than others.

This book provides a fresh, multidisciplinary, and exciting look at the making and remaking of pharmaceutical patents at the GATT/WTO, by utilising a Coxian political economy of continuity and change in the global political economy (GPE). Marcellin focuses on the role of the transnational drug industry in the making of the patent provisions in the original TRIPS Agreement and consequently, the role of the African Group at the WTO in the remaking of those patent provisions.

This book focuses on the lives, struggles, and contrasting perspectives of the 60,000 workers, military administrators, and technical staff employed in the largest, most strategic industry of the Nationalist government, the armaments industry based in the wartime capital, Chongqing. The author argues that China's arsenal workers participated in three interlocked conflicts between 1937 and 1953: a war of national liberation, a civil war, and a class war. The work adds to the scholarship on the Chinese revolution, which has previously focused primarily on rural China, showing how workers’ alienation from the military officers directing the arsenals eroded the legitimacy of the Nationalist regime and how the Communists mobilized working-class support in Chongqing. Moreover, in emphasizing the urban, working-class, and nationalist components of the 1949 revolution, the author demonstrates the multiple sources of workers’ identities and thus challenges previous studies that have exclusively stressed workers’ particularistic or regional identities.

This new edition provides an alternative overview of 18th-century British economy. Recent macroeconomic history has discounted many of the achievements of the Industrial Revolution, but this text dissects the characteristics and processes of industry in the 18th century. A male industrial revolution has been presented as the general experience, but new industries, notably in textiles and metal products, were primarily employers of women. This work gives these industries and their workforce due prominence. Technologies, work processes, labour forces and markets shifted in a variety of directions and forms to create a sector of dynamic new initiatives alongside stable and declining crafts. The key to the Industrial Revolution lies in the sources of technological creativity and the structures of industrial communities. The rise of the factory system was one result. This text reasserts the primacy of the industrial experience to Britain's economic history.

The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.

Written by John Lidstone and Janice MacLennan, the second edition of Marketing Planning for the Pharmaceutical Industry became accepted as the bible for the industry. In this new companion book Janice MacLennan picks up two of the themes touched on in Marketing Planning - market segmentation and branding, and the inter-relationship between these two - and with this book makes them key topics for discussion. Brand Planning for the Pharmaceutical Industry begins by exploring what branding is and why it is of importance, particularly to the pharmaceutical sector. The book then goes on to show how branding can be integrated into the early stages of the commercialization process for new products, both in theory and in the 'real' world. The book provides a step-by-step guide to brand planning, using market segmentation as the starting point. The book is split into two parts, the first dealing comprehensively with brand planning for products yet to get to the market, with the second part applying the same process to products that are already on the market. Both parts are extremely pragmatic, full of pertinent examples and insights from the pharmaceutical industry, and are directly applicable to your own brand planning. Brand Planning for the Pharmaceutical Industry concludes by confronting the problems that organizations are likely to have in actually making brand planning an integral part of their work and presents strategies for dealing with them.

How much does regulation matter in shaping corporate behavior? This pathbreaking, in-depth study of fourteen pulp manufacturing mills in the United States, Canada, Australia, and New Zealand reveals that steadily tightening regulatory standards have been crucial for raising environmental performance. But while all firms have shown improvement, some have improved more than others, many going substantially beyond compliance. What explains the variation in compliance? It's not necessarily the differences in regulation in each country. Rather, variation is accounted for by the complex interaction between tightening regulations and a social license to operate (especially pressures from community and environmental activists), economic constraints, and differences in corporate environmental management style. Shades of Green provides the most extensive and systematic empirical study to date of why firms achieve the levels of environmental performance that they do.

In 1950, a diagnosis of cancer was all but a death sentence. Mortality rates only got worse, and as late as 1986, an article in the New England Journal of Medicine lamented: We are losing the war against cancer." Cancer is one of humankind's oldest and most persistent enemies it has been called the existential disease.But we are now entering a new, and more positive, phase in this long campaign. While cancer has not been cured,and a cure may elude us for a long time yet,there has been a revolution in our understanding of its nature. Years of brilliant science have revealed how this individualistic disease seizes control of the foundations of life,our genes,and produces guerrilla cells that can attack and elude treatments. Armed with those insights, scientists have been developing more effective weapons and producing better outcomes for patients. Paul A. Marks, MD, has been a leader in these efforts to finally control this devastating disease.Marks helped establish the strategy for the war on cancer" in 1971 as a researcher and member of President Nixon's cancer panel. As the president and chief executive officer for nineteen years at the world's pre-eminent cancer hospital, the Memorial Sloan-Kettering Cancer centre, he was instrumental in ending the years of futility. He also developed better therapies that promise a new era of cancer containment. Some cancers, like childhood leukemia and non-Hodgkin's lymphoma, that were once deadly conditions, are now survivable,even curable. New steps in prevention and early diagnosis are giving patients even more hope. On the Cancer Frontier is Marks' account of the transformation in our understanding of cancer and why there is growing optimism in our ability to stop it.

Basic Manufacturing has already established itself as a core text for manufacturing courses in Further Education. The new edition has been revised to be fully in line with the new Vocational GCSE in Manufacturing from Edexcel, covering the three compulsory units of this scheme, and will continue to act as a core text for Intermediate GNVQ. Coverage of the two schemes is combined throughout the text, yet each chapter clearly illustrates which sections map to which units within the two scheme specifications. The author's approach is student-centred with self-check questions and activities provided throughout. As a result, the book is well suited to independent study. It is also clearly written to appeal to students of all abilities. Review questions are provided at the end of each chapter to consolidate learning and give practice for external assessments. The third edition contains a brand new chapter to cater for the examinable part of the GCSE syllabus (Unit 3), which includes case studies in the six sectors covered in the scheme: food and drink/biological and chemical; printing and publishing/paper and board; textiles and clothing; engineering fabrication; mechanical/automotive engineering; electrical and electronic engineering/computer/process control/telecommunications. The book is an excellent, readable introduction to the technical and business aspects of the manufacturing industry that will be invaluable for students on a wide range of courses, including City and Guilds certificates. It also provides a good grounding for students embarking on higher-level programmes within Manufacturing. Roger Timings is one of the UK's leading authors of textbooks on manufacturing and engineering.

What we eat - as well as how it is produced, processed, moved, sold, and used by our bodies seems to matter like never before. Global Foodscapes takes on this topicality and asks readers to think about how we are all involved in the making of an odd and, in many ways, troubling and contested food economy. It explores how food is conceived, traded, grown, reared, processed, sold, and consumed; investigates what goes wrong along the way; and assesses what diverse people around the world are doing to fix these faults. The text uses a carefully-crafted framework that explores the interaction of five forms of oppression and five means of resistance as they are worked out over five stages in the food economy. It draws on case studies from around the world that illuminate key issues about food in today's world; examines how oppression affects diverse people caught up in the food economy; and highlights how individuals, groups, and institutions such as governments, but also firms, are trying to improve how we interact with the food system. Global Foodscapes is a highly accessible and useful text for undergraduate students interested in the global food economy. The global range of case studies, examples, and reference points, as well as its original framework allows the text to speak to diverse audiences and generate debate about whether anything - and if so, what - needs to be done about the food system we depend upon so heavily. Additional materials such as suggested readings and discussion points help students consider the issues at hand and conduct initial and more detailed research on today's food economy.

Now in its ninth edition, Air Transportation: A Global Management Perspective by John Wensveen is a well-proven, accessible textbook that offers a comprehensive introduction to the theory and practice of air transport management. In addition to explaining the fundamentals, the book transports the reader to the leading edge of the discipline, using past and present trends to forecast future challenges and opportunities the industry may face, encouraging the reader to think deeply about the decisions a manager implements. The word "Global" has been added to the subtitle for this edition, reflecting an increased emphasis on worldwide operations including North America, Latin America/Caribbean, Europe, Asia-Pacific, the Middle East and Africa. The ninth edition focuses on the "Age of Acceleration", addressing trends related to emerging technologies, such as autonomy, artificial intelligence, augmented reality, virtual reality, 3-D printing, data analytics, block chain, cybersecurity, etc. New material includes extra information on airport management and operations, air carrier business models, aviation risk, safety and security, and how changing political landscapes impact the aviation industry. Enhanced content is supported by the addition of new chapters and online supplemental resources including PowerPoint presentations, chapter quizzes, exam questions and links to online resources. This wide-ranging textbook is appropriate for nearly all aviation programs that feature business and management. Its student-friendly structure and style make it highly suitable for modular courses and distance-learning programs, or for self-directed study and continuing personal professional development.

What we eat - as well as how it is produced, processed, moved, sold, and used by our bodies seems to matter like never before. Global Foodscapes takes on this topicality and asks readers to think about how we are all involved in the making of an odd and, in many ways, troubling and contested food economy. It explores how food is conceived, traded, grown, reared, processed, sold, and consumed; investigates what goes wrong along the way; and assesses what diverse people around the world are doing to fix these faults. The text uses a carefully-crafted framework that explores the interaction of five forms of oppression and five means of resistance as they are worked out over five stages in the food economy. It draws on case studies from around the world that illuminate key issues about food in today's world; examines how oppression affects diverse people caught up in the food economy; and highlights how individuals, groups, and institutions such as governments, but also firms, are trying to improve how we interact with the food system. Global Foodscapes is a highly accessible and useful text for undergraduate students interested in the global food economy. The global range of case studies, examples, and reference points, as well as its original framework allows the text to speak to diverse audiences and generate debate about whether anything - and if so, what - needs to be done about the food system we depend upon so heavily. Additional materials such as suggested readings and discussion points help students consider the issues at hand and conduct initial and more detailed research on today's food economy.

This book provides a systematic analysis of the law and practice of EU competition/antitrust law and trade regulation in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-profile competition enforcers, this work provides valuable insider knowledge on the application of competition law and policies to the pharmaceutical industry. Key features include: Extensive commentary on the legislation and the latest case law and administrative precedents in the pharmaceutical sector, at both EU and national level Coverage of various key developments including the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers In-depth analysis of topics commonly raised in the pharmaceutical sector including: pricing policies, IP life-cycle management, IP licensing and horizontal cooperation agreements Key economic and business perspectives to accompany legal analysis, providing the reader with a rounded view of the subject matter. This book will be a useful resource for lawyers and in-house counsel active in the pharmaceutical sector. The information and analysis provided will prepare readers to take on cases and drive the antitrust review of transactions and agreements within the industry. Researchers, economists and civil servants with an interest in competition law and trade regulation can also benefit from the practical insights provided therein.

Car Safety Wars is a gripping history of the hundred-year struggle to improve the safety of American automobiles and save lives on the highways. Described as the "equivalent of war" by the Supreme Court, the battle involved the automobile industry, unsung and long-forgotten safety heroes, at least six US Presidents, a reluctant Congress, new auto technologies, and, most of all, the mindset of the American public: would they demand and be willing to pay for safer cars? The "Car Safety Wars" were at first won by consumers and safety advocates. The major victory was the enactment in 1966 of a ground breaking federal safety law. The safety act was pushed through Congress over the bitter objections of car manufacturers by a major scandal involving General Motors, its private detectives, Ralph Nader, and a gutty cigar-chomping old politician. The act is a success story for government safety regulation. It has cut highway death and injury rates by over seventy percent in the years since its enactment, saving more than two million lives and billions of taxpayer dollars. But the car safety wars have never ended. GM has recently been charged with covering up deadly defects resulting in multiple ignition switch shut offs. Toyota has been fined for not reporting fatal unintended acceleration in many models. Honda and other companies have-for years-sold cars incorporating defective air bags. These current events, suggesting a failure of safety regulation, may serve to warn us that safety laws and agencies created with good intentions can be corrupted and strangled over time. This book suggests ways to avoid this result, but shows that safer cars and highways are a hard road to travel. We are only part of the way home.

This book provides insight into the potential for the market to protect and improve labour standards and working conditions in global apparel supply chains. It examines the possibilities and limitations of market approaches to securing social compliance in global manufacturing industries. It does so by tracing the historic origins of social labelling both in trade union and consumer constituencies, considering industry and consumer perspectives on the benefits and drawbacks of social labelling, comparing efforts to develop and implement labelling initiatives in various countries, and locating social labelling within contemporary debates and controversies about the implications of globalization for workers worldwide. Scholars and students of globalisation, development, corporate social responsibility, human geography, labour and industrial relations, business ethics, consumer behaviour and fashion will find its contents of relevance. CSR practitioners in the clothing and other industries will also find this useful in developing policy with respect to supply chain assurance.