Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this three-volume reference provides detailed information on specialized products, such as emulsions, liposomes, polymers, and polymeric pharmaceutical excipients. Written by over twenty-five international experts, it explains the requirements for conducting clinical research and obtaining approval for new drug products-furnishing a current, comprehensive review of U.S. drug regulations.

This work considers the concepts and constraints that have to be considered in the design of small, medium and large scale production plants. The layout, along with the flow of materials and personnel through facilities are considered with reference to ensuring compliance with current good manufacturing practice. The book explains how clean rooms have developed, and how recent regulations affect their design. The latest concepts for reducing contamination levels from the operator and the product are discussed. It assess current changes in standards and quality control and makes suggestions for the "ideal production environment" to enable standards to be validated to current standards.

eBook available with sample pages: 0203483111

Elements of Pharmaceutical Pricing shows account managers, product managers, marketing researchers, and other practitioners in the pharmaceutical industry how to improve your marketing and pricing skills. By describing the process for reaching pricing decisions and clarifying the environment of pharmaceutical marketing, this book demystifies the area of pharmaceutical pricing and shows how to use prices to capture the value of products instead of lowering their value. Recent pharmaceutical pricing decisions have reflected uninformed, emotional, and short-term thinking. Elements of Pharmaceutical Pricing shows you how to avoid these kinds of decisions, helping you refine your pricing skills and increase your firm's profitability by: showing you how to determine the value of a pharmaceutical product outlining a pricing philosophy that addresses the politics and problems you'll encounter tracing the pricing research process examining the role of price in the decision to purchase, prescribe, or use pharmaceuticals addressing the challenges facing the industry in the future As Dr. Kolassa explains in the Foreword, Elements of Pharmaceutical Pricing aims to "help create within [pharmaceutical] firms, and the industry, something that has been long overdue--the ability to 'price on purpose,'to make pricing decisions that are less emotional and more informed. This volume does not contain all the answers, but I believe it does pose many of the right questions, to help those charged with pricing to make informed decisions, to understand the likely implications of their pricing actions before taking them. This information should lead to better, more profitable pricing in the industry."

Elements of Pharmaceutical Pricing shows account managers, product managers, marketing researchers, and other practitioners in the pharmaceutical industry how to improve your marketing and pricing skills. By describing the process for reaching pricing decisions and clarifying the environment of pharmaceutical marketing, this book demystifies the area of pharmaceutical pricing and shows how to use prices to capture the value of products instead of lowering their value. Recent pharmaceutical pricing decisions have reflected uninformed, emotional, and short-term thinking. Elements of Pharmaceutical Pricing shows you how to avoid these kinds of decisions, helping you refine your pricing skills and increase your firm's profitability by: showing you how to determine the value of a pharmaceutical product outlining a pricing philosophy that addresses the politics and problems you'll encounter tracing the pricing research process examining the role of price in the decision to purchase, prescribe, or use pharmaceuticals addressing the challenges facing the industry in the future As Dr. Kolassa explains in the Foreword, Elements of Pharmaceutical Pricing aims to "help create within [pharmaceutical] firms, and the industry, something that has been long overdue--the ability to 'price on purpose,'to make pricing decisions that are less emotional and more informed. This volume does not contain all the answers, but I believe it does pose many of the right questions, to help those charged with pricing to make informed decisions, to understand the likely implications of their pricing actions before taking them. This information should lead to better, more profitable pricing in the industry."

For decades, medical professionals have betrayed the public's trust by accepting various benefits from the pharmaceutical industry. Both drug company representatives and doctors employ artful spin to portray this behavior positively to the public, and to themselves. In Hooked, Howard Brody argues that we can neither understand the problem, nor propose helpful solutions until we identify the many levels of activity connecting these purportedly noble industries. We can pass laws and enact regulations, but ultimately the medical profession must take responsibility for its own integrity. Hooked is a wake-up call for anyone expecting high quality, ethical medical care.

This unique reference provides the first systematic coverage available in a single-source volume on the application of materials science techniques to the pharmaceutical field-offering a comprehensive program for the physical characterization of raw materials, drug substances, and formulated products.

This title was first published in 2003. Presenting information is a vital part of the job of both the medical director and other senior executives in the pharmaceutical industry, and yet the majority receive no training for this. Presentations have to be made internally to colleagues, clinical staff, marketing and product managers and medical sales representatives; and externally to professional medical specialists and NHS staff, the media and the general public. Anyone who manages or communicates adverse news needs to do so quickly and effectively, and be prepared to face difficult questions under media scrutiny. In this book, John Lidstone, an author acknowledged by the industry as an expert in marketing and presentation skills, provides readers with the tools and skills to make their presentations and media dealings a success. The book is divided into two parts. Part One, Preparing and Delivering Formal Presentations, provides extensive practical guidance on the techniques of effective presenting: establishing objectives and preparing the presentation, delivering the opening, core and conclusion, using visual aids and dealing with questions. It also includes a chapter on the skills required for video conferencing. The second part, Handling the Media, contains invaluable insight and instruction for a pharmaceutical executive facing any element of the media. It draws on the author's extraordinary experience and provides examples and advice with direct relevance to the pharmaceutical industry throughout, making this the only specialist book available on the subject.

This book explores why Japan, despite being a world leader in many high technology industries such as automobiles and consumer electronics, is only a minor player in the global pharmaceutical industry. Japan provides a huge market for pharmaceuticals as the second largest consumer of prescription drugs after the United States, and is a massive importer of prescription drugs, relying on discoveries made elsewhere. This book charts the development of the industry, from the devastation resulting from the Second World War to its performance in the present day. Focusing in particular on antibiotics and anticancer drugs, the book analyses factors that have prevented Japan from leading the rapid advances in science and technology that have occurred globally over recent decades. Looking at the pharmaceutical industry, the book argues that the Japanese government's research and development policies were not sufficiently incentivising. It also shows how the nature of capitalism in Japan - which featured close relations between government and industry as well as between and within firms - was appropriate for nurturing industrial development in the immediate post-war decades, but became much less effective in later years.

'Bad Science' hilariously exposed the tricks that quacks and journalists use to distort science, becoming a 400,000 copy bestseller. Now Ben Goldacre puts the $600bn global pharmaceutical industry under the microscope. What he reveals is a fascinating, terrifying mess. Doctors and patients need good scientific evidence to make informed decisions. But instead, companies run bad trials on their own drugs, which distort and exaggerate the benefits by design. When these trials produce unflattering results, the data is simply buried. All of this is perfectly legal. In fact, even government regulators withhold vitally important data from the people who need it most. Doctors and patient groups have stood by too, and failed to protect us. Instead, they take money and favours, in a world so fractured that medics and nurses are now educated by the drugs industry. The result: patients are harmed in huge numbers. Ben Goldacre is Britain's finest writer on the science behind medicine, and 'Bad Pharma' is the book that finally prompted Parliament to ask why all trial results aren't made publicly available - this edition has been updated with the latest news from the select committee hearings. Let the witty and indefatigable Goldacre show you how medicine went wrong, and what you can do to mend it.

In the post-liberalization period, India has slowly but steadily tried to foster innovation to improve competitive efficiency of Indian manufacturing and thus boost global competitiveness of the industrial sector. Foreign direct investment was looked upon as a major source of technology paradigm shift; in recent times, industrial firms have been investing overseas, even in countries to which they used to export, based on their technological capabilities. Firms in Indian manufacturing industries have also attempted to bring about technological upgrades through imports of design and drawings (disembodied technology) against lump sum, royalty and technical knowhow fees, and imports of capital machinery (embodied technology) where the technology is embodied in the capital good itself. This volume comprises empirical contributions on this emerging phenomenon, on a range of issues including the role of R mergers, acquisitions and technological efforts; technological determinants of competitive advantages; the role of small and medium enterprises and regional patterns; technological efforts and global operations; and the role of industrial clusters in promoting innovation and competitiveness. This book was originally published as a special issue of Innovation and Development.

In virtually every decision, a pharmaceutical executive considers some type of forecast. This process of predicting the future is crucial to many aspects of the company - from next month's production schedule, to market estimates for drugs in the next decade. The pharmaceutical forecaster needs to strike a delicate balance between over-engineering the forecast - including rafts of data and complex 'black box' equations that few stakeholders understand and even fewer buy into - and an overly simplistic approach that relies too heavily on anecdotal information and opinion. Art Cook's highly pragmatic guide explains the basis of a successful balanced forecast for products in development as well as currently marketed products. The author explores the pharmaceutical forecasting process; the varied tools and methods for new product and in-market forecasting; how they can be used to communicate market dynamics to the various stakeholders; and the strengths and weaknesses of different forecast approaches. The text is liberally illustrated with tables, diagrams and examples. The final extended case study provides the reader with an opportunity to test out their knowledge. Forecasting for the Pharmaceutical Industry is a definitive guide for forecasters as well as the multitude of decision makers and executives who rely on forecasts in their decision making.

This authoritative reference covers recent advances in the field, stressing an interdisciplinaryapproach to the development and use of biosensor technology in physics,engineering, analytical chemistry, and biochemistry (including immunochemistry).about the editors ...RICHARD P. BucK is a Professor in the Chemistry Department, University of Northcarolina, Chapel Hill. Professor Buck serves on the editorial boards of severaljournals including Analytical Instrumentation: Applications and Designs for Chemica~Biomedica~ and Environmental Science (Marcel Dekker, Inc.). He is a member of theAmerican Chemical Society, Electrochemical Society, and International Society ofElectrochemistry. He received the B.S. (1950) and M.S. (1951) degrees from thecalifornia Institute of Tochnology, Pasadena, and Ph.D. degree (1954) from theMassachusetts Institute of Tochnology, cambridge.W1WAM E. HATFIELD is Mary Ann Smith Professor and Vice Chairman of Chemistry,and Acting Chairman of the Curriculum in Applied Sciences, University of Northcarolina, Chapel Hill. He is the author or coauthor of over 300 publications, andcoeditor, with John H. Miller, Jr., of High-Temperature Superconducting Materials:Preparations, Properties, and Processing (Marcel Dekker, Inc.). He is a member of theAmerican Chemical Society, American Association for the Advancement of Science,and Materials Research Society. He received the B.S. (1958) and M.S. (1959) degreesfrom Marshall University, Huntington, West Virginia, Ph.D. degree (1962) from theUniversity of Arizona, Tucson, and completed postdoctoral research at the Universityof Illinois, Urbana.M1KTHA UMANA is an independent consultant to Glaxo Inc. and Research 'IriangleInstitute, Research 'Iriangle Park, and Duke University Engineering Research Center,Durham, North carolina. The coauthor of numerous scientific journal articles, herresearch interests include surface chemistry, electrochemistry, and biosensors. Shereceived the B.Sc. degree (1969) from the University of Chile, Santiago, and Ph.D.degree (1972) from the University of London, England.EDMOND E BowoEN is an Associate Professor in the Department of Chemistry andin the Biotechnology Program, North carolina State University, Raleigh. Thecoauthor of numerous journal articles, his research interests include bioelectrochemistry,biological electron transfer, biosensors, and surface chemistry. He receivedthe B.S. degree (1970) from Syracuse University, Syracuse, New York, and Ph.D.degree (1982) from Virginia Commonwealth University, Richmond.

Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers needs, the drug will fail to reach its intended market value. Introduction to Market Access for Pharmaceuticals is based on an accredited course in this area, taken from the European Market Access University Diploma (EMAUD), and is affiliated with Aix Marseille University.

This book is devoted to building up the case that the drug industry has systematically corrupted science to play up the benefits and play down the harms of their drugs. It describes the activities of the drug industry to organised crime.

This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation's knowledge assets can provide a path towards business excellence.

'What gets measured gets fixed' and this is as true of the pharmaceutical industry as any other. The problem is that pharmaceutical businesses are complex. Drug research and development involves extended and expensive processes; defining appropriate metrics for these processes is not easy, yet ineffective or misguided metrics can be more damaging than none at all. David Zuckerman's Pharmaceutical Metrics is an extremely practical guide to selecting a system, selling it to top management, choosing and defining the right metrics for your system, communicating and displaying the results. And because metrics are about how to shape and develop your business, he explores how to deploy them organization-wide and make sure that they are driving business improvement. In order to reflect the needs of different types of pharmaceutical company the author uses four sample companies, throughout the book, to illustrate the principles for 'big pharma', 'micro pharma', a virtual development company and a CRO. This highly practical book provides a step-by-step guide to creating a state-of-the-art, strategy-driven metrics system for pharmaceutical R&D, supported by case studies of the techniques applied and tips for optimizing the system.

During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices. This book is a must-have for pharmaceutical, biotechnology and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget.

Drug-related morbidity and mortality is rampant in contemporary industrial society, despite or perhaps because, government has assumed a critical role in the process by which drugs are developed and approved. Parrish asserts that, as a people, Americans need to understand how it is that government became the arbiter of pharmaceutical fact. The consequences of our failure to understand, he argues, may threaten individual choice and forestall the development of responsible therapeutics. Moreover, if current standards and control continues unabated, the next therapeutic reformation might well make possible the sanctioned commercial exploitation of patients. In Defining Drugs, Parrish argues that the federal government became arbiter of pharmaceutical fact because the professions of pharmacy and medicine, as well as the pharmaceutical industry, could enforce these definitions and standards only through police powers reserved to government. Parrish begins his provocative study by examining the development of the social system for regulating drug therapy in the United States. He reviews the standards that were negotiated, and the tensions of the period between Progressivism and the New Deal that gave cultural context and historical meaning to drug use in American society. Parrish describes issues related to the development of narcotics policy through education and legislation facilitated by James Beal and Edward Kremers, and documents the federal government's evolving role as arbiter of market tensions between pharmaceutical producers, government officials, and private citizens in professional groups, illustrating the influence of government in writing enforceable standards for pharmaceutical therapies. He shows how the expansion of political rights for practitioners and producers has shifted responsibility for therapeutic consequences from individual practitioners and patients to government. This timely and controversial volume is written for the scholar and the compassionate practitioner alike, and a general public concerned with pharmacy regulation in a free society.

The pharmaceutical industry faces a well-documented perfect storm: on the one hand, the patent cliff; the lack of new blockbusters and, on the other, economic pressure on pricing from markets with growing expectations and shrinking budgets. In the face of such pressure, traditional health economics models no longer seem appropriate and yet what do we have to replace them? The growing focus on 'value' and 'cost effectiveness' are evidence of new emerging thinking although, even here, with the shift from medicine as cure to medicine as palliative, as a treatment for chronic illness and with the growing emphasis on preventative approaches, the landscape is complex and challenging. The Future of Health Economics offers a window into some of the most influential emerging issues in pharmacoeconomics; issues such as risk-sharing and alternative pricing models or the potential impact of radical new approaches such as personalized medicine; as well as exploring the changing role of government and regulators. Ulf Staginnus and Olivier Ethgen, themselves two of the most well-regarded practitioners in this field, have brought together some leading-edge thinkers from industry and academia around the world to provide the industry, policy-makers, regulators, health practitioners and academics with the raw material for their future scenarios.

By any standard, the pharmaceutical industry's history has been a successful one. In addition to its profits and shareholder dividends, it has been seen by investors as relatively low risk and, largely, counter-cyclical to stock market trends. However, that important contribution appears to be petering out, with significant global implications for employees, shareholders, governments and patients. This is not just caused by the economic crisis. Long before this, several distinct but related streams of evidence emerged that now point to the stalling of the pharmaceutical industry. The Future of Pharma examines the causes of the industry's potential decline and offers a convincing and rigorous analysis of the options open to it. What emerges is a landscape defined, on the one hand, by the changing marketplace of mass-market consumers, institutional healthcare systems and wealthy individuals; and on the other by the alternate sources of commercial value - innovative therapies; super-efficient processes, supply chains and operations; and closer customer relations and increasingly tailored health services. The challenges to the pharmaceutical industry now and in the medium and long-term are very significant. Brian Smith's highly readable research findings are a wake-up call and a first step forward for anyone concerned with the future of the industry; whether executive, customer, policymaker or investor.

The Open Access version of this book, available at http://www.tandfebooks.com, has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. An exploration of how global pharmaceutical products are localized - of what happens when they become 'glocal' - this book examines the tensions that exist between a global pharmaceutical market and the locally bounded discourses and regulations encountered as markets are created for new drugs in particular contexts. Employing the case study of the emergence, representation and regulation of Viagra in the Swedish market, Glocal Pharma offers analyses of commercial material, medical discourses and legal documents to show how a Swedish, Viagra-consuming subject has been constructed in relation to the drug and how Viagra is imagined in relation to the Swedish man. Engaging with debates about pharmaceuticalization, the authors consider the ways in which new identities are created around drugs, the redefinition of health problems as sites of pharmaceutical treatment and changes in practices of governance to reflect the entrance of pharmaceuticals to the market. With attention to 'local' contexts, it reveals elements in the nexus of pharmaceutcalization that are receptive to cultural elements as new products become embedded in local markets. An empirically informed study of the the ways in which the presence of a drug can alter the concept of a disease and its treatment, understandings of who suffers from it and how to cure it - both locally and internationally - this book will appeal to scholars of sociology and science and technology studies with interests in globalization, pharmaceuticals, gender and the sociology of medicine.

As the most common health-care intervention, prescription drug use shares the most important characteristics of the health-care system in the United States. When everything works well, it makes possible breathtakingly successful applications of science to the prevention and cure of human suffering. But everything doesn't always work well. Pharmaceutical Public Policy provides the understanding and framework required for effective organization, financing, and delivery of pharmaceutical products and services. It supplies an overview of the policy process as well as the roles of legislation and regulation in pharmaceutical policy. The book identifies the goals, objectives, and key policy issues of concern to stakeholders involved in the development of products, use of pharmaceuticals in healthcare, and administration of insurance programs by both the private and government sectors. Policy issues examined include the appropriateness of prescribing and patient adherence. Addressing questions of access, quality, and cost, the book considers the operation of the Affordable Care Act and Medicare Part D. It details the responsibilities of Federal providers of pharmaceutical care and private and public payers such as managed care organizations, pharmacy benefit managers, Medicare, and Medicaid. The book covers the policies and practices involved in promoting pharmaceutical products. It also considers pharmacoeconomics as a response to market failure. Finally, the book describes the market, the role of the manufacturer, drug shortages, and the responsibilities of the FDA. The book includes a Foreword by Jerry Avorn, MD, Professor of Medicine, Harvard Medical School; and Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Woman's Hospital.

The process of discovery in science and technology may require investigation of a large number of features, such as factors, genes or molecules. In Screening, designed experiments and statistical analyses of the resulting data sets are used to identify efficiently the few features that determine key properties of the system under study.

This book brings together accounts by leading international experts that are essential reading for those working in fields such as industrial quality improvement, engineering research and development, genetic and medical screening, drug discovery, and computer simulation of manufacturing systems or economic models. Our aim is to promote cross-fertilization of ideas and methods through detailed explanations, a variety of examples and extensive references.

Topics cover both physical and computer simulated experiments. They include screening methods for detecting factors that affect the value of a response or its variability, and for choosing between various different response models. Screening for disease in blood samples, for genes linked to a disease and for new compounds in the search for effective drugs are also described. Statistical techniques include Bayesian and frequentist methods of data analysis, algorithmic methods for both the design and analysis of experiments, and the construction of fractional factorial designs and orthogonal arrays.

The material is accessible to graduate and research statisticians, and to engineers and chemists with a working knowledge of statistical ideas and techniques. It will be of interest to practitioners and researchers who wish to learn about useful methodologies from within their own areaas well as methodologies that can be translated from one area to another.

Research and Development is the vehicle by which organizations and economies create opportunity, innovation and secure a stream of future products and services.These outcomes are all critically important sources of sustainability in a world that is changing faster than most companies can keep up.The challenge behind them is the fundamental unpredictability of R which is why effective project management is so important. Ron Basu's Managing Projects in Research and Development explains how and why project management can provide a means of helping to plan, organise and control multi-disciplinary research activities without stifling innovation. Combining research with practical examples and experience from a career that has included blue chip organizations such as GSK, GlaxoWellcome and Unilever, Ron Basu offers a rigorous guide to the fundamentals of R&D project management including project lifecycle management, risk management, cost, time quality and other success measures as well as the keys to operational excellence in this complicated world.

Forecasting for the Pharmaceutical Industry is a definitive guide for forecasters as well as the multitude of decision makers and executives who rely on forecasts in their decision making. In virtually every decision, a pharmaceutical executive considers some type of forecast. This process of predicting the future is crucial to many aspects of the company - from next month's production schedule, to market estimates for drugs in the next decade. The pharmaceutical forecaster needs to strike a delicate balance between over-engineering the forecast - including rafts of data and complex 'black box' equations that few stakeholders understand and even fewer buy into - and an overly simplistic approach that relies too heavily on anecdotal information and opinion. Arthur G. Cook's highly pragmatic guide explains the basis of a successful balanced forecast for products in development as well as currently marketed products. The author explores the pharmaceutical forecasting process; the varied tools and methods for new product and in-market forecasting; how they can be used to communicate market dynamics to the various stakeholders; and the strengths and weaknesses of different forecast approaches. The text is liberally illustrated with tables, diagrams and examples. The final extended case study provides the reader with an opportunity to test out their knowledge. The second edition has been updated throughout and includes a brand new chapter focusing on specialized topics such as forecasting for orphan drugs and biosimilars.