In a world that is changing, everybody in business wants to know how to achieve and maintain success. This is the case whether your business is local, national, or global, and no matter the products or services you provide. This book sets out the impressive rise of Tiens Group, which started locally, expanded nationally, and now operates globally from its headquarters in China. The book provides not only an analysis of the factors that have contributed to the success, but also sets out examples of how these factors can be adapted to other business enterprises. In this book, you will discover deep insight into how notions such as swap and transcendence assist in business development, a sense of how Chinese businesses have developed across the world, and an understanding of how both clear focus and an ability to adapt are critical to business success.

There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to ensure that the economic success of the industry does not come at the expense of public safety, yet they have also assumed a cooperative role by providing advice on regulation and by targeting unmet medical needs. Concerns over regulatory standards, conflicts of interest, and the manipulation of information on drug safety and effectiveness have led to public mistrust and a greater need for transparency between the pharmaceutical industry and government regulators. Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry responsible for creating transparency in the industry, from development to market. The contributors to this volume examine the various mechanisms introduced to make the regulatory process more informative and situate these efforts within the larger project of enhancing the safety of drugs, vaccines, and other products.

Formally Plunkett's Biotech & Genetics Industry Almanac, this book is a complete reference guide to the business side of biotechnology, genetics, proteomics and related services. This new book contains complete profiles of the leading biotech companies; in-depth chapters on trends in genetics, technologies, statistics and finances; a handy glossary; and thorough indexes. For the first time, in one carefully-researched volume, you'll get all of the data you need. Topics include: biotechnology funding and investments; activities in Singapore, China and India; FDA; gene therapies; personalized medicine; systems biology; clinical trials; stem cells; therapeutic cloning; nanotechnology; agricultural biotechnology (GM seeds); drug delivery systems; and ethical issues. The book includes complete profiles on 350 top Biotech & Genetics companies, our own unique list of companies that are the leaders in biotechnology. All of the corporate profile information is indexed and cross-indexed. Includes contact names, addresses, Internet addresses, fax numbers and toll-free numbers, plus growth and hiring plans, finances, research, marketing, technology, acquisitions and much more for each firm. You'll find a complete overview, industry analysis and market research report in one superb, value-priced package.

Ultrafiltration technology has been widely used in many fields such as water purification, chemical separation, pharmaceutical production, food processing, seawater desalination pre-treatment, and more. This book provides new research on the processes and uses of ultrafiltration. Chapter One reviews the preparation and application of hollow fibre ultrafiltration membrane. Chapter Two details the ultrafiltration of surfactin (lipopeptide), one of the most well-known biosurfactants and suggests a similar process for mannosylerythritol lipids (glycolipid), one of the most prominent biosurfactants. Chapter Three provides an overview on ultrafiltration in food processing. Chapter Four addresses a suitable methodology for fouling control on an ultrafiltration membrane. Chapter Five discusses the effect of anions on the removal of mercury(II) using FeS-supported crossflow ultrafiltration.

This book includes information about the express assessment of cell viability in biological preparations, interfacial tension, and phase behaviour in emulsions of associative biopolymers. Also discussed are the conditions of shear flow, and interaction and structure formation of gelatin type A with thermo aggregates of bovine serum albumin, and perspectives of application of multi-angle laser light scattering and methods for quality control of medicines. A new approach to the creation of biocompatible magnetically targeted nanosystems for a smart delivery of therapeutic products, polyelectrolyte microsensors as a new tool for metabolites' detection, and improvement of the functional properties of lysozyme by interaction with 5-methylresorcinol is also reviewed. The methods of study of the processes of the issue of the optical information biological object, polyelectrolyte enzyme-bearing microdiagnosticum, and a new step in clinical-biochemistry analysis and introductions in culture in in-vitro rare bulbous plants of the Sochi Black Sea Coast (Scilla, Muscari, Galanthus) are studied.

According to the World Health Organization, one-third of the global population lacks access to essential medicines. Should pharmaceutical companies be ethically or legally responsible for providing affordable medicines for these people, even though they live outside of profitable markets? Can the private sector be held accountable for protecting human beings' right to health? This thought-provoking interdisciplinary collection grapples with corporate responsibility for the provision of medicines in low- and middle-income countries. The book begins with an examination of human rights, norms, and ethics in relation to the private sector, moving to consider the tensions between pharmaceutical companies' social and business duties. Broad examinations of global conditions are complemented by case studies illustrating different approaches for addressing corporate conduct. Access to Medicines as a Human Right identifies innovative solutions applicable in both global and domestic forums, making it a valuable resource for the vast field of scholars, legal practitioners, and policymakers who must confront this challenging issue.

This book overviews and integrates the business and technical issues that pharmaceutical companies need to know in order to combat the major global problem of counterfeit medicines. In addition to discussion of the problems, the author Davison addresses analytical techniques scientists use to detect counterfeits and presents some possible solutions to the threat of counterfeit medical products. Coverage moves from basic overview of the problem, costs / risks to consumers (toxic products, mistrust of drug companies) and business (revenue loss, public trust), government oversight and regulation, authentication strategies (packaging, analytical techniques), product tracking and supply chain, and case studies from around the globe.

Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study -- prepared at the request of the Senate Majority Leader -- reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D.

An analysis of how we regulate the pharmaceutical industry: are we protecting patients or blocking the development of useful new drugs? This book is the first to offer a comprehensive examination of the pharmaceutical industry by following the tortuous course of a new drug as it progresses from early development to final delivery. Richard A. Epstein looks closely at the regulatory framework that surrounds all aspects of making pharmaceutical products today, and he assesses which current legal and regulatory practices make sense and which have gone awry. While critics of pharmaceutical companies call for ever more stringent controls on virtually every aspect of drug development and approval, Epstein cautions that the effect of such an approach will be to stifle pharmaceutical innovation and slow the delivery of beneficial treatments to the patients who need them. The author considers an array of challenges that confront the industry--conflicts of interest among government, academe, and the drug companies; intellectual property rights that govern patents; FDA regulation; pricing disputes; marketing practices; and liability issues, including those brought to light in the recent VIOXX case. Epstein argues that to ensure the continuing creativity, efficiency, and success of the pharmaceutical industry, the best system will feature strong property rights and clearly enforceable contracts, with minimal regulatory and judicial interference.

In some parts of the world spending on pharmaceuticals is astronomical. In others people do not have access to basic or life-saving drugs. Individuals struggle to afford medications; whole populations are neglected, considered too poor to constitute profitable markets for the development and distribution of necessary drugs. The ethnographies brought together in this timely collection analyze both the dynamics of the burgeoning international pharmaceutical trade and the global inequalities that emerge from and are reinforced by market-driven medicine. They demonstrate that questions about who will be treated and who will not filter through every phase of pharmaceutical production, from preclinical research to human testing, marketing, distribution, prescription, and consumption.

Whether considering how American drug companies seek to create a market for antidepressants in Japan, how Brazil has created a model HIV/AIDS prevention and treatment program, or how the urban poor in Delhi understand and access healthcare, these essays illuminate the roles of corporations, governments, NGOs, and individuals in relation to global pharmaceuticals. Some essays show how individual and communal identities are affected by the marketing and availability of medications. Among these are an exploration of how the pharmaceutical industry shapes popular and expert understandings of mental illness in North America and Great Britain. There is also an examination of the agonizing choices facing Ugandan families trying to finance AIDS treatment. Several essays explore the inner workings of the emerging international pharmaceutical regime. One looks at the expanding quest for clinical research subjects; another at the entwining of science and business interests in the Argentine market for psychotropic medications. By bringing the moral calculations involved in the production and distribution of pharmaceuticals into stark relief, this collection charts urgent new territory for social scientific research.

"Contributors." Kalman Applbaum, Joao Biehl, Ranendra K. Das, Veena Das, David Healy, Arthur Kleinman, Betty Kyaddondo, Andrew Lakoff, Anne Lovell, Lotte Meinert, Adriana Petryna, Michael A. Whyte, Susan Reynolds Whyte

First made in the late 19th century, paracetamol is now widely used in a variety of pharmaceutical products. It is used as a painkiller and to reduce the temperature of patients with a fever. Aimed at post-16 students, this book provides a series of classroom activities, both written and practical, relating to paracetamol. The activities can be carried out singly, or as a coherent package, and are supported by a guide for teachers and technicians.

This book tells the story of two generations of Pietist ministers sent from Halle, in Brandenburg Prussia during the eighteenth century, to the German communities of North America. In conjunction with their clerical office, these ministers provided medical services using pharmaceuticals and medical texts brought with them from Europe. Their practice is an example of how different medical markets and medical cultures evolved in North America.

At the heart of the story is the Francke Orphanage, a famous religious and philanthropic foundation started in Halle in 1696. Pharmaceuticals from Halle were manufactured and sold throughout Europe as part of a commercial enterprise designed to support Francke's charitable goals. Halle's reputation for consistent product quality and safety soon spread to North America, where men and women became actively engaged in providing medical care to Lutheran and Reformed congregations along the east coast, mainly the backcountry of Pennsylvania, New Jersey, Maryland, and Virginia. The story continues to about 1810, when Halle's North American clergy had become independent from the motherhouse and American medical practice and education began to follow its own course.

Wilson draws upon a large array of correspondence, trading ledgers, and daybooks in European and American archives. Through these records she enables us to see firsthand the experience of men and women as both patients and practitioners. The result is a rare glimpse into the world of German medicine and the pharmaceutical trade in eighteenth-century North America.

Error-proofing in the production process of pharmaceuticals isn't just a matter of good business, it has life-and-death implications for consumers. To that end, the 2013 Drug Quality and Security Act in large part requires new mandates on tracking and tracing chain of custody in the supply chain. Pharmaceutical Supply Chain: Drug Quality and Security Act overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights. The book focuses on the delicate balance between protecting the public through legislation against negligent compounding pharmacies and protecting patients by assuring a supply of needed compounded drugs by not over-regulating the industry. The author discusses lessons learned from the earlier e-pedigree initiatives, the technology advances that enable supply chain security, and how the industry will need to respond to the myriad of threats facing the pharmaceutical drug supply chain and comply with this act. He goes in depth into each segment of the pharmaceutical drug supply chain, describing the industry segment and how it will need to adapt to the new act. By incorporating real-world examples of industry leaders, the book underlines the contributions of individuals who have made a difference through innovations and execution. It also addresses how laws are made, and specifically how the Drug Quality and Security Act was passed by Congress and signed into law. In an industry that is so big, you may feel that you cannot make a difference. This book provides you with key insights on how the forward supply chain process should work and how anyone can make a difference at all levels.

Over the past few decades, there has been unprecedented progress in the design of versatile biopolymer-based nanoplatforms for pharmaceutical and biomedical applications, particularly due to their attractive traits, including excellent biocompatibility, outstanding biodegradability, low immunogenicity, and facile chemical modifiability. Biopolymer-Based Nanomaterials in Drug Delivery and Biomedical Applications serves as a clear and detailed body of information on the synthesis and characterization of biopolymer-based materials in nanomedicine. This book describes various nanomaterials consisting of biopolymers including polysaccharides (i.e., derived from plants, animals, bacteria, algae, and fungi) and polypeptides in terms of their structures, synthetic protocols, and characterization and uses as therapeutic drugs and gene delivery carriers and in other biomedical fields. The chapters of this book, which are contributed by internationally renowned scholars working in the arena of biopolymer-based nanomaterials, would offer a wide vision on the potential future applications of these nanomaterials in the delivery and targeting of bioactive molecules of pharmaceutical interests and in tissue engineering, biosensing, bioimaging, and diagnostic purposes. The state-of-the-art information presented in the book would also encourage young investigators and researchers to further bring cutting-edge developments in the field of nanomedicine in the near future.

The biopharmaceutical industry as we know it today is going through a massive upheaval as a result of the uncertainty of healthcare reform and increasing regulatory pricing pressure. A wake-up call to all sectors of the healthcare value chain, Patient-Focused Network Integration in BioPharma: Strategic Imperatives for the Years Ahead explores patient-focused network integration as quite possibly the only way for organizational evolution to occur. The book discusses how to align enterprises with the patient at the center. It details the historical context of the biopharmaceutical value chain and the current set of challenges facing the industry, and then details the author's unique and sustainable agenda for change. The book traces the critical but often ignored relationships between hospitals, insurance companies, biopharma manufacturers, government regulators, and clinical scientists. For too long, these parties have been operating in a void, without recognizing the interconnectedness of their objectives, even though these objectives are often competing and misaligned. This book points out the gaps that exist and develops a set of recommendations regarding disease treatments, clinical development of new products, and collaboration between these players that can result in a sustainable solution to the healthcare mess. Each chapter can be viewed as an independent essay, in that it deals with a specific dimension of the healthcare value chain. However, together they provide an integrated discussion on how to begin the task of creating an integrated value chain network for healthcare. The book begins with the patient, and then works its way back down the value chain, all the way to the drug development and clinical trials stage of the value chain. The common thread throughout the chapters is the emphasis on collaboration, strategic alignment, and a focus on delivering value to the end patient. Very simply, all parties in the healthcare value chain network must align their strategic planning to derive innovation solutions. It is only through true collaboration and aligned thinking that the parties in the drug development, distribution, insurance payors, and hospital provider network can deal with the incredible complexity and massive challenges that face the industry. The book provides a compelling maturity model that enables readers to gauge the level of network integration their enterprise is at today, and where they need to move in the future.

Every year the average number of prescriptions purchased by Americans increases, as do healthcare expenditures, which are projected to reach one-fifth of the U.S. gross domestic product by 2020. In "Drugs for Life," Joseph Dumit considers how our burgeoning consumption of medicine and cost of healthcare not only came to be, but also came to be taken for granted. For several years, Dumit attended pharmaceutical industry conferences; spoke with marketers, researchers, doctors, and patients; and surveyed the industry's literature regarding strategies to expand markets for prescription drugs. He concluded that underlying the continual growth in medications, disease categories, costs, and insecurity is a relatively new perception of ourselves as inherently ill and in need of chronic treatment. This perception is based on clinical trials that we have largely outsourced to pharmaceutical companies. Those companies in turn see clinical trials as investments and measure the value of those investments by the size of the market and profits that they will create. They only ask questions for which the answer is more medicine. "Drugs for Life" challenges our understanding of health, risks, facts, and clinical trials, the very concepts used by pharmaceutical companies to grow markets to the point where almost no one can imagine a life without prescription drugs.

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.

Vaccines have saved more lives than any other single medical advance. Yet today only four companies make vaccines, and there is a growing crisis in vaccine availability. Why has this happened? This remarkable book recounts for the first time a devastating episode in 1955 at Cutter Laboratories in Berkeley, California, thathas led many pharmaceutical companies to abandon vaccine manufacture. Drawing on interviews with public health officials, pharmaceutical company executives, attorneys, Cutter employees, and victims of the vaccine, as well as on previously unavailable archives, Dr. Paul Offit offers a full account of the Cutter disaster. He describes the nation’s relief when the polio vaccine was developed by Jonas Salk in 1955, the production of the vaccine at industrial facilities such as the one operated by Cutter, and the tragedy that occurred when 200,000 people were inadvertently injected with live virulent polio virus: 70,000 became ill, 200 were permanently paralyzed, and 10 died. Dr. Offit also explores how, as a consequence of the tragedy, one jury’s verdict set in motion events that eventually suppressed the production of vaccines already licensed and deterred the development of new vaccines that hold the promise of preventing other fatal diseases.

This book is published in association with the Office of Health Economics. This book is a vital, non-technical guide illuminating recent developments within the five major European pharmaceutical markets. It clearly explains pharmaceutical regulatory policies on pricing and reimbursement, and their effects. Each chapter gives an overview of the current market, including aims, effectiveness, local markets, frameworks and politics, and then offers predictions for the next decade. Pharmaceutical executives with interests in marketing, market access and pricing will find this guide invaluable, as will health economists, government advisors and public affairs consultants. Public policy makers in areas such as the Department of Health and The Treasury and senior health service managers in hospitals will find it enlightening. It is also highly relevant to policy shapers in academia and the media, and undergraduate and postgraduate students of health economics, health policy, pharmaceutical economics and healthcare management. "This book aims not only to understand and discuss the mix of regulatory measures introduced by national policy makers in order to achieve their goals, but also to ascertain how these policies have actually shaped and influenced the characteristics and functioning of national pharmaceutical markets. In particular, each author has provided an analysis of existing pricing and reimbursement arrangements operating in their own country and an outline of policy scenarios that might emerge in the next decade." - Martina Garau and Jorge Mestre-Ferrandiz, in the Introduction.

The bestselling and most useful aid available for finding all references to FDA and DEA regulations, Interpharm Master Keyword Guide: 21 CFR Regulations of the Food and Drug Administration, is used in hundreds of active pharmaceuticals, pharmaceutical, biotechnology, diagnostic, and device manufacturing companies. And it is in use by every FDA district in the United States to sort their way through their own regulations. Each of the over 20,000 entries is quoted in context to provide instant access to every noun, phrase, and concept used by the DEA and FDA. The KEYWORD and SECTION TITLE are shown in upper case, the Subpart Title and/or Part Title are shown in capitals and lower case.

How to use this guide:
1. Look up the keyword of interest
2. Note the context in which the keyword is mentioned in the section of title and the details of the subpart or part title to determine if it is the reference you need
3. When you find the correct reference, use the section number provided to look up the details of the regulations in the Code of Federal Regulations Title 21

Updated to include the latest changes in 21 CFR, the Interpharm Master Keyword Guide: 21 CFR Regulations of the Food and Drug Administration, 2002-2003 Edition makes it easy to find the exact section you need and apply it correctly.

Health activist, scholar, award-winning journalist, and cancer survivor Sharon Batt investigates the relationship between patient advocacy groups and the pharmaceutical industry as well as the contentious role of pharma funding. Over the past several decades, a gradual reduction in state funding has pressured patient groups into forming private-sector partnerships. This analysis of Canada's breast cancer movement from 1990 to 2010 shows that the resulting power imbalance undermined the groups' ability to put patients' interests ahead of those of the funders. A movement that once encouraged democratic participation in the development of health policy now eerily echoes the demands of the pharmaceutical industry.

The increasing resistance of bacteria to antibiotics, and pests to pesticides, threatens to undo some of the most remarkable advances made in public health and agriculture during the past century. Though the potential consequences of increased antibiotic and pesticide resistance are far reaching, regulatory efforts to address the problem are at a very early stage. Battling Resistance to Antibiotics and Pesticides moves such discussions forward by presenting cutting edge research and the first comprehensive application of economic tools to analyze how antibiotics and pesticides should be used to maximize their value to society. Laxminarayan and his contributors explore lessons from past experiences with resistance, especially in agriculture. They consider what incentives would be ideal for the individuals who prescribe or apply antibiotics and pesticides, and what would be ideal for the firms engaged in developing and producing these products. The chapters in this groundbreaking book reflect the fact that efforts to combat resistance will require contributions from a broad range of scholars and professionals, representing a broad range of expertise. The analysis demonstrates that, for all these participants, an understanding of economic issues is an essential complement to knowledge of medical or biological factors. The book provides economists with an overview of relevant scientific issues, as well as a variety of analytical approaches to studying the economics of resistance. It offers policymakers detailed analyses of the multiple dimensions of resistance and discusses the future strategies to combat and manage resistance. For professionals in medicine, public health, and agriculture, the book translates the economic approaches into usable guidance for daily practice and decisionmaking.

This book evaluates the performance of the Indian pharmaceutical industry, which plays an important role in economic development. It highlights the role the government has had in facilitating the growth of the industry from non-existence, before the 1970s, to being one of the largest pharmaceutical industries in the world today. The text employs various useful techniques to provide an understanding of productivity and efficiency, such as data envelopment analysis, stochastic frontier analysis, the Malmquist Productivity Index and the Hicks-Moorsteen Productivity Index. The book will be useful to health administrators, students of public policy, and health economists with an interest in the pharmaceutical sector.