Neoliberals often point to improvements in public health and nutrition as examples of globalisation's success, but this book argues that the corporate food and medicine industries are destroying environments and ruining living conditions across the world. Scientist Stan Cox expertly draws out the strong link between Western big business and environmental destruction. This is a shocking account of the huge damage that drug manufacturers and large food corporations are inflicting on the health of people and crops worldwide. Companies discussed include Wal-Mart, GlaxoSmithKline, Tyson Foods and Monsanto. On issues ranging from the poisoning of water supplies in South Asia to natural gas depletion and how it threatens global food supplies, Cox shows how the demand for profits is always put above the public interest. While individual efforts to 'shop for a better world' and conserve energy are laudable, Cox explains that they need to be accompanied by an economic system that is grounded in ecological sustainability if we are to find a cure for our Sick Planet.

Over-the-Counter products comprise a special category of healthcare products. While these formulations have much in common with their prescription counterparts, they are presented in this series separately because of their development approach taken, labeling considerations required, and support available from suppliers of ingredients in designing these products. Highlights from Over-the-Counter Products, Volume Five include: solids, liquids, and suspensions practical advice on how to bring manufacturing practices into compliance with regulatory requirements cGMP considerations in great detail a large number of formulations of coatings of solid dosage forms

Encompassing the full spectrum of project management s role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through clinical development, manufacturing, registration, and launch.

New updated material includes:

• expert recommendations and informative articles on decision-making
• planning principles and planning systems
• management of subcontracted development
• manufacturing project management
• team leadership and skill sets
• drug development strategies

It covers primary project management objectives, functions, and descriptions of the nature and execution of work activities in a clear and reader-friendly format to illustrate key characteristics and objectives, assist managers in projecting the risks and challenges of each development option, and supply concise recommendations for successful project planning.

The pharmaceutical industry is under increasing pressure to do more with less. Drug discovery, development, and clinical trial costs remain high and are subject to rampant inflation. Ever greater regulatory compliance forces manufacturing costs to rise despite social demands for more affordable health care. Traditional methodologies are failing and the industry needs to find new and innovative approaches for everything it does. Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics is the first book to focus on the building blocks of understanding and reducing variation using the Six Sigma method as applied specifically to the pharmaceutical industry. It introduces the fundamentals of Six Sigma, examines control chart theory and practice, and explains the concept of variation management and reduction. Describing the approaches and techniques responsible for their own significant success, the authors provide more than just a set of tools, but the basis of a complete operating philosophy. Allowing other references to cover the structural elements of Six Sigma, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry. The first half of the book uses simple models and descriptions of practical experiments to lay out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Designed primarily for the pharmaceutical industry, Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics provides the fundamentals of variation management and reduction in sufficient detail to assist in transforming established methodologies into new and efficient techniques.

Vast global resources are ploughed into the delivery of treatment interventions ranging from diet and lifestyle advice to complex surgery. In all cases, whatever the intervention, unless the recipient is engaged with the process and understands why the intervention has been offered and the part they play in its success, compliance is an issue. Even where the individual does engage and understand, he or she may choose not to comply. Non-compliance is estimated to cost the pharma industry US$70 billion per year. No figures exist for the cost to healthcare insurers and public health but non-compliance is undoubtedly one of the top five issues facing both drug developers and healthcare providers. During clinical trials, non-compliance undermines the accuracy of the data generated from the whole trial as well as particular aspects such as the efficacy of different dosages. This book explores the key factors which drive compliance and the part that healthcare professionals can play in improving this, with the key underlying goal of improving public health in its broadest sense.

From Physick to Pharmacology addresses the important, albeit neglected history of the distribution and sale of medicinal drugs in England from the sixteenth to the twenty-first century. The social history of early medicine and the evolution of British retailing are two areas that have attracted considerable attention from academics in recent years. That said, little work has been done either by medical or business historians on the actual retailing of drugs. This book merges the two themes by examining the growth in the retailing of medicinal drugs since late-medieval times. The six academics contributing essays include both medical and business historians who provide an informed and stimulating perspective on the subject. After an introduction setting out the context of drug retailing and surveying the current literature, the volume is arranged in a broadly chronological order, beginning with Patrick Wallis's study of apothecaries and other medical retailers in early modern London. The next chapter, by Louise Hill Curth, looks at the way the distribution network expanded to encompass a range of other retail outlets to sell new, branded, pre-packaged proprietary drugs. Steven King then examines various other ways in which medicines were sold in the eighteenth century, with a focus on itinerant traders. This is followed by pieces from Hilary Marland on the rise of chemists and druggists in the nineteenth century, and Stuart Anderson on twentieth-century community pharmacists. The final essay, by Judy Slinn, examines the marketing and consumption of prescription drugs from the middle of that century until the present day. Taken together, these essays provide a fascinating insight into the changes and continuities of five centuries of drug retailing in England.

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards

Melville's Monumental Imagination explores the connection between the contested 19th century American monument tradition and one of the nation's most revered authors, Herman Melville (1819-1891). The book was written to fill a void in recent Melville scholarship. To date, there has not been a monograph that focuses exclusively on Melville's incorporation of monuments in his fictional world. The book charts the territory of Melville's novels in order to provide a trajectory of the monumental image in one particular literary form. This feature allows the reader to gradually see the monumental image as an important marker that sheds light into Melville's eventual abandonment of long fiction. Melville's Monumental Imagination combines literary analysis and cultural criticism for a long neglected aspect of our nation's iconic development in statuary.

Israel's 2003 election took place against the background of a deteriorating security situation (due to Palestinian violence and the impending US War in Iraq) and severe disillusionment with the Oslo peace process. The election, which brought about a decisive victory of the Likud Party and Ariel Sharon, took place amidst strong accusations of corruption and the virtual collapse of the Israeli left. The election also featured the rise of the anti-clerical Shinui party, which resulted in the exclusion of the ultra-Orthodox parties from the new coalition. In this volume, leading Israeli political scientists explore the main actors and processes that shaped the election and its outcome.
This book was previously published as a special issue of the journal Israel Affairs.

When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshals seize products if a voluntary recall is not done. Drugs can be seized and medical devices can be detained and imports can be stopped at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties-including prison sentences-are sought. Ensuring that your company is in compliance at all times in all departments is a never-ending task. Failure to get it right, even once, can mean excessive fines, penalties, or possible debarment. The FDA Administrative Enforcement Manual explores the control of drug research in pharmaceutical, vaccine, biologic, biotechnology, medical device, and cosmeceutical industries. Introducing basic industry techniques, the author explores every day industry problems and presents suggested methods for applying the theory to resolve them. The book covers the ten critical Administrative Enforcement areas, including recalls, application integrity, injunctions, seizures, and more. It supplements these topics with regulations, lawsuit case studies, enforcement information, and reference materials. Offering insight into the impact of FDA enforcement on the national and international pharmaceutical industry, practitioners and industry suppliers, the book provides an understanding of drug development and manufacturing regulations in the United States and shows you what it takes to keep your company in compliance. The only complete, single source available, the FDA Administrative Enforcement Manual draws on the author's experience in the trenches of the pharmaceutical industry with administrative enforcement activities.

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 authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.

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.

Leads readers through the multitude of tasks involved in the control of microbiological contamination in the production of parenteral drugs. This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.

Lists the necessary steps for meeting compliance requirements during the drug development process. Presents comprehensive approaches for validating analytical methods for pharmaceutical applications. Features key discussions on pre-approval inspections.

Contents:
1. Introduction 2. The Pharmaceutical Development Process 3. The Medical Device Development Process 4. Functions and Types of CRO's (referencing function listings in appendices) 5. Selection of CRO 6. Pricing and Cost 7. Monitoring Work 8. Common Problems and their Solutions

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.

The pharmaceutical industry is broken. From the American hedge fund manager who hiked the price of an AIDS pill from $17.50 to $750 overnight to the children's cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system that was designed to drive innovation and patient care has been relentlessly distorted to drive up profits. Medicines have become nothing more than financial assets. The focus of drug research, how drugs are priced and who has access to them is now dictated by shareholder value, not the good of the public. Drug companies fixated on ever-higher profits are being fined for bribing doctors and striking secret price-gouging deals, while patients desperate for life-saving medicines are driven to the black market in search of drugs that national health services can't afford. Sick Money argues that the way medicines are developed and paid for is no longer working. Unless we take action we risk a dramatic decline in the pace of drug development and a future in which medicines are only available to the highest bidder. In this book investigative journalist Billy Kenber offers a diagnosis of an industry in crisis and a prescription for how we can fight back.

The goal of an activity-directed isolation process is to isolate bioactive compounds which may provide structural leads of therapeutic importance. Whereas the traditional process of drug development is long and expensive, simple and rapid bioassays can serve as the starting point for drug discovery. This book presents a range of "bench top" bioassay techniques useful for natural product and pharmaceutical chemists involved in drug discovery and pharmacognosy. The contents detail a number of enzyme-based assays, cell-based functional bioassays and receptor radioligand binding assays along with detailed descriptions of each type. The majority of these bioassays are presented in a step-by-step format, so they could even be implemented by technical personnel with little background in microbiology, biochemistry or pharmacology.

Medicinal Chemistry of Anticancer Drugs, Third Edition provides an updated resource for students and researchers from the point-of-view of medicinal chemistry and drug design, focusing on the mechanism of action of antitumor drugs from the molecular level, and on the relationship between chemical structure and chemical and biochemical reactivity of antitumor agents. The new edition includes updated sections on the hot topic of cancer immunotherapy, cancer polypharmacology, multitargeted cancer therapy, medicinal chemistry of cancer diagnosis, theragnostic anticancer agents, and pre-mRNA processing in cancer. Although many books are available that deal with clinical aspects of cancer chemotherapy, this book provides a unique and valuable perspective from the point-of-view of medicinal chemistry and drug design. It will be useful to undergraduate and postgraduate students of medicinal chemistry, pharmacology, biological chemistry, pharmacy and other health sciences. Researchers and practitioners will find a comprehensive treatment of the topic and a large number of references, reviews and primary literature.

Scientific communication is challenging. The subject matter is complex and often requires a certain level of knowledge to understand it correctly; describing hazard ratios, interpreting Kaplan Meier curves and explaining confounding factors is different from talking about a new car or clothing range. Processes, for example in clinical trials, are laborious and tedious and knowing how much of the detail to include and exclude requires judgement. Conclusions are rarely clear cut making communicating statistical risk and probability tough, especially to non-statisticians and non-scientists such as journalists. Communicating Clearly about Science and Medicine looks at these and many more challenges, then introduces powerful techniques for overcoming them. It will help you develop and deliver impactful presentations on medical and scientific data and tell a clear, compelling story based on your research findings. It will show you how to develop clear messages and themes, while adhering to the advice attributed to Einstein: 'Make things as simple as possible...but no simpler.' John Clare illustrates how to communicate clearly the risks and benefits contained in a complex data set, and balance the hope and the hype. He explains how to avoid the 'miracle cure' or 'killer drug' headlines which are so common and teaches you how to combine the accuracy of peer-to-peer reviewed science with the narrative skills of journalism.

This Book explains and investigates how medicines are controlled in Europe, especially the EU. Based on penetrating documentary and interview research with the pharmaceutical industry, regulators and consumer organisations,it provides the first major critical examination of the new Europeanised systems of medicine regulation. The authors argue that the drive to produce and approve more drugs more quickly for a single European market dominates other considerations, such as improvements in democratic accountability, the independence of regulators and scientific expertise from commercial interests, and drug safety testing and surveillance.

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.