Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry.

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control training. It gives readers a toolbox for ensuring that adequate controls are implemented.

The introduction of combinatorial chemistry technology has increased the amount of compounds generated in a year from 50 to 2000. Conventional analytical approaches simply cannot keep up. These circumstances have caused drug discovery to take on the shape of a bottleneck, like traffic through a toll booth. In order to break the bottleneck, a corresponding revolutionary improvement to the conventional methodology must happen.

Parallel trade occurs if international price differences for identical products are high and a policy of regional or international exhaustion of the respective property right has been implemented in the high price country. The work by C. Poget analyses how parallel imports of pharmaceuticals are affecting end consumer prices and drug expenditures in three Scandinavian countries, Sweden, Denmark and Norway. Based on his observations he derives proposals for policy reforms in EU member countries and Switzerland.

This book examines an important phenomenon for competitiveness and innovation in industry: namely the growing use of scientific principles in industrial research. Industrial innovation still arises from systematic trial-and-error experiments with many designs and objects, but these experiments are being guided by a more rational understanding of phenomena. This has important implications for market structure, firm strategies and competition. Science and Innovation focuses on the pharmaceutical industry. It discusses the changes that the notable advances in the life sciences since the 1980s have exerted on the strategies of drug companies, the organization of their internal research, their relationships with scientific institutions, the division of labour between large pharmaceutical firms and small research-intensive suppliers, the productivity of drug discovery and the productivity of R & D.

How to hone your analytical skills and obtain high-quality data in the era of GMP requirements

With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide. Based on Johnson & Johnson's acclaimed in-house training program, this practical guide provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies. Highly qualified industry experts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods-from spectroscopy to chromatography to dissolution. An ideal manual for formal training as well as an excellent self-study guide, Analytical Chemistry in a GMP Environment features:

• The drug development process in the pharmaceutical industry
• Uniform and consistent interpretation of GMP compliance issues
• A review of the role of statistics and basic topics in analytical chemistry
• An emphasis on high-performance liquid chromatographic (HPLC) methods
• Chapters on detectors and quantitative analysis as well as data systems
• Methods for ensuring that instruments meet standard operating procedures (SOP) requirements
• Extensive appendixes for unifying terms, symbols, and procedural information

This book proposes an integrated approach to patent risk and capital budgeting in pharmaceutical research and development (R and D), developing an option-based view (OBV) of imperfect patent protection, which draws upon contingent-claims analysis, stochastic game theory, as well as novel numerical methods. The text re-initiates a discussion about the contribution of quantitative frameworks to value-based R and D management.

The productivity in pharmaceutical research and development faces intense pres sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re cord level of close to US$ 1 billion today. As a result, any failure of a new sub stance in the R&D process can lead to considerable losses, and the risks of introduc ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year."

The art of solving a structure from powder diffraction data has developed rapidly over the last ten years to the point where numerous crystal structures, both organic and inorganic, have been solved directly from powder data. However, it is still an art and, in contrast to its single crystal equivalent, is far from routine. The art lies not only in the correct application of a specific experimental technique or computer program, but also in the selection of the optimal path for the problem at hand. Written and edited by experts active in the field, and covering both the fundamental and applied aspects of structure solution from powder diffraction data, this book guides both novices and experienced practitioners alike through the maze of possibilities.

Merck and the pharmaceutical industry are headline news today. Controversies over public safety, prices, and the ability of the industry to develop the new drugs and vaccines that society needs have been covered worldwide. Roy Vagelos, who was head of research and then CEO at Merck from the mid-1970s through the early 1990s, addresses these issues here. Success with targeted research started Merck on a path that would lead to a series of block-buster therapies that carried the firm to the top of the global industry in the 1990s and Vagelos into the top position at the company. Trained as a physician and scientist, he had to learn how to run a successful business while holding to the highest principles of ethical behavior. He was not always successful. He and his co-author explain where and why he failed to achieve his goals and carefully analyze where he succeeded.

Silas Burroughs arrived in London from America in 1878 and proved himself an exceptional entrepreneur, taking the pharmaceutical business by storm. He was the brains and energy behind Burroughs Wellcome & Co. With his business partner Henry Wellcome he created an internationally successful firm, the legacy of which can be found in the charity the Wellcome Trust, yet few now remember him and the impact he made in his short lifetime. A consummate salesman, Burroughs was also an astute businessman, with new ideas for marketing, advertising and manufacturing: his writings describe sales trips around the world and the people he met. He was also a visionary employer who supported the eight-hour working day, profit-sharing, and numerous social and radical political movements, including the single tax movement, free travel, Irish Home Rule and world peace. In this first biography of Burroughs, Julia Sheppard explores his American origins, his religion and marriage, and his philanthropic work, as well as re-evaluating the dramatic deterioration of his relationship with his partner Wellcome.

For most Western audiences, Cuba is a touristic paradise stuck in time and virtually detached from world technology networks by the US embargo - anything but a hub of industrial innovation and high value-added biotechnology. However, a closer look reveals more subtle but equally powerful stories that challenge the homogenizing assumptions of conventional economics and open up scope for more sophisticated reflections on Cuban economy and industry. From this kind of enquiry emerges the case of the internationally respected Cuban biotech industry as the most successful case of science and technology policy in the country's economic history. The book takes an interdisciplinary approach, exploring issues such as interdependency, purpose and history as natural constituencies of the innovation process. It also examines the dynamic and crucial role played by the state in the formation of innovative business enterprises. This book will be of interest to academic researchers in the fields of innovation and economic development.

Who wins the race to turn molecules into medicines? How much does it cost? What factors influence the choice of synthetic routes and reaction mechanisms? How can pharmaceutical companies protect their discoveries? In From Bench to Market, Walter Cabri and Romano Di Fabio chart the process of industrial chemical synthesis, from the first discovery of a molecule to its entry in the marketplace as a drug. Using real case histories of drug development from several therapeutic areas, they discuss all aspects related to the process research for bulk production, including comparison between different synthetic routes, key methodologies and reaction mechanisms, costs, patent competition, and crystalline forms.

Nanotechnology Based Approaches for Tuberculosis Treatment discusses multiple nanotechnology-based approaches that may help overcome persisting limitations of conventional and traditional treatments. The book summarizes the types of nano drugs, their synthesis, formulation, characterization and applications, along with the most important administration routes. It also explores recent advances and achievements regarding therapeutic efficacy and provides possible future applications in this field. It will be a useful resource for investigators, pharmaceutical researchers, innovators and scientists working on technology advancements in the areas of targeted therapies, nano scale imaging systems, and diagnostic modalities in tuberculosis.

Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries.

In Silico Drug Design: Repurposing Techniques and Methodologies explores the application of computational tools that can be utilized for this approach. The book covers theoretical background and methodologies of chem-bioinformatic techniques and network modeling and discusses the various applied strategies to systematically retrieve, integrate and analyze datasets from diverse sources. Other topics include in silico drug design methods, computational workflows for drug repurposing, and network-based in silico screening for drug efficacy. With contributions from experts in the field and the inclusion of practical case studies, this book gives scientists, researchers and R&D professionals in the pharmaceutical industry valuable insights into drug design.

Collaborative Creativity is a powerful methodology for groups that uses short bursts of creative challenges to help people go beyond rational/conscious thinking and uncover, with constructive consequences, the emotional/irrational sphere that influences behaviour. It was developed by Peter Comber specifically for the complex environment of the healthcare industry, and this how-to manual for managers of healthcare companies offers practical advice on how to employ creative processes in their sector.

While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.

In 2010, Thea Cacchioni testified before the US Food and Drug Administration against flibanserin, a drug proposed to treat low sexual desire in women, dubbed by the media the "pink Viagra." She was one of many academics and activists sounding the alarm about the lack of science behind the search for potentially lucrative female sexual enhancement drugs. In her book, Big Pharma, Women, and the Labour of Love, Cacchioni moves beyond the search for a sexual pharmaceutical drug for women to ask a broader question: how does the medicalization of female sexuality already affect women's lives? Using in-depth interviews with doctors, patients, therapists, and other medical practitioners, Cacchioni shows that, whatever the future of the "pink Viagra," heterosexual women often now feel expected to take on the job of managing their and their partners' sexual desires. Their search for sexual pleasure can be a "labour of love," work that is enjoyable for some but a chore for others. An original and insightful take on the burden of heterosexual norms in an era of compulsory sexuality, Cacchioni's investigation should open up a wide-ranging discussion about the true impact of the medicalization of sexuality.

Situated at the crossroads between the history of colonialism, of modern Southeast Asia, and of medical pluralism, this history of medicine and health traces the life of pharmaceuticals in Vietnam under French rule. Laurence Monnais examines the globalization of the pharmaceutical industry, looking at both circulation and consumption, considering access to drugs and the existence of multiple therapeutic options in a colonial context. She argues that colonialism was crucial to the worldwide diffusion of modern medicines and speaks to contemporary concerns regarding over-reliance on pharmaceuticals, drug toxicity, self-medication, and the accessibility of effective medicines. Retracing the steps by which pharmaceuticals were produced and distributed, readers meet the many players in the process, from colonial doctors to private pharmacists, from consumers to various drug traders and healers. Yet this is not primarily a history of medicines as objects of colonial science, but rather a history of medicines as tools of social change.

Polymers are one of the most fascinating materials of the present era finding their applications in almost every aspects of life. Polymers are either directly available in nature or are chemically synthesized and used depending upon the targeted applications.Advances in polymer science and the introduction of new polymers have resulted in the significant development of polymers with unique properties. Different kinds of polymers have been and will be one of the key in several applications in many of the advanced pharmaceutical research being carried out over the globe. This 4-partset of books contains precisely referenced chapters, emphasizing different kinds of polymers with basic fundamentals and practicality for application in diverse pharmaceutical technologies. The volumes aim at explaining basics of polymers based materials from different resources and their chemistry along with practical applications which present a future direction in the pharmaceutical industry. Each volume offer deep insight into the subject being treated. Volume 1: Structure and Chemistry Volume 2: Processing and Applications Volume 3: Biodegradable Polymers Volume 4: Bioactive and Compatible Synthetic/Hybrid Polymers

Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

"The public health of the developing world is the single issue of greatest significance for humanity over the next half century. This important book offers thoughtful analysis and practical ideas for confronting and addressing this issue through research and development of lifesaving vaccines."--Lawrence H. Summers, President, Harvard University

"Michael Kremer and Rachel Glennerster have produced a work of outstanding importance to the well-being of developing countries. "There are five billion people in the poor world, many suffering from debilitating or fatal diseases. The potential gains in overcoming this human suffering from the development of effective and cost-efficient vaccines are enormous. Yet the economic purchasing power of the rich world favors the development of vaccines and drugs for the rich world. "Strong Medicine" presents workable incentives for research and development to respond more powerfully to the human needs of poor people. Kremer and Glennerster have produced results that deserve the attention of all those who work in development and that chart a way forward for one of the greatest issues of our time."--Nicholas Stern, Second Permanent Secretary at HM Treasury in the United Kingdom, Visiting Professor at the London School of Economics, and former Chief Economist of the World Bank

""Strong Medicine" is full of insights that can make a real difference to the morbid world in which we live. It combines powerful analytical reasoning with practical insights and empirical knowledge to explore a highly promising way of expanding incentives for medicinal research. The possibility of making a significant difference through a commitment to purchase effectivevaccines as and when they are developed is thoroughly scrutinized in this definitive investigation, for which we have reason to be grateful."--Amartya Sen, Harvard University, Nobel Laureate in Economic Sciences

"This important book, on how to design markets for drugs to treat millions of diseased people in the developing world, has the added advantage of being an interesting read. The authors convey very well the intellectual excitement associated today with putting mechanism design into practice. They take the reader, one step at a time, through the various levels at which problems might arise and then show how the design is meant to take care of these problems."--Abhijit Banerjee, Massachusetts Institute of Technology

"Michael Kremer is likely the most thoughtful advocate of an exciting new approach for tackling the scourges of AIDS, malaria, and other diseases that primarily afflict the populations of less developed countries. In this book, he and Rachel Glennerster offer by far the most complete discussion I have seen of why this approach--one that would see authorities stimulate private efforts to develop medical treatment by providing a guaranteed market for them--should be adopted, and of how to deal with problems of implementation and design."--Kenneth Sokoloff, University of California, Los Angeles

This unique reference examines the modern pharmaceutical compacting techniques used to form tablets out of powders-describing the physical structure of pharmaceutical compacts, the bonding phenomena that occur during powder compaction, and the compression mechanisms of pharmaceutical particles.