This book is the definitive work on the theory and practice of pharmaceutical tablet and pellet coating. It describes both the practical and theoretical aspects of tablet coating, including the equipment and methods used in laboratory development, scale-up and production systems, More...as well as automation and validation. This book also discusses the problems of conforming to world-wide regulations, and the hazards of environmental pollution.

In the US alone, pharmaceutical companies spend around $7 billion a year on clinical trials for drugs; all this in a global market where increasing competition and pressure on healthcare financing are both impacting on margins and profitability. One solution for pharmaceutical companies lies within the clinical trials themselves. If only you can communicate the trial findings to the right people, in the right way, you can benefit from this huge investment and add significant value to your product range and your brand. Successfully Marketing Clinical Trials Results is a comprehensive guide for every marketing professional faced with the challenge of using marketing to convert scientific data into sales. The book offers you practical knowledge on how to use medical research data to maximise the revenue from your products. There are sections explaining how to: identify your market and devise your strategy; develop your content and translate data into a message that has impact; use language, layout and illustrations to best effect; communicate internally as well as externally; make best use of the resources available; align your sales force and the external agencies with whom you work; lead the people in the project team; co-operate with the medical researchers, external experts and the press. In this book are answers for everything from how to handle class-effect questions to developing a shared brand vocabulary. There are plenty of vivid examples and real-life applications to reinforce the ideas. Cases studies illustrate solutions to problems; checklists and tips will help to implement the suggestions and recommendations. Gunter Umbach has distilled the essence both of 25 years' experience in the healthcare market and of his highly successful seminar series on marketing clinical trials into the professional advice given in this book. The text is accompanied by a CD ROM containing detailed Powerpoint slides supporting e

In the US alone, pharmaceutical companies spend around $7 billion a year on clinical trials for drugs; all this in a global market where increasing competition and pressure on healthcare financing are both impacting on margins and profitability. One solution for pharmaceutical companies lies within the clinical trials themselves. If only you can communicate the trial findings to the right people, in the right way, you can benefit from this huge investment and add significant value to your product range and your brand. Successfully Marketing Clinical Trials Results is a comprehensive guide for every marketing professional faced with the challenge of using marketing to convert scientific data into sales. The book offers you practical knowledge on how to use medical research data to maximise the revenue from your products. There are sections explaining how to: identify your market and devise your strategy; develop your content and translate data into a message that has impact; use language, layout and illustrations to best effect; communicate internally as well as externally; make best use of the resources available; align your sales force and the external agencies with whom you work; lead the people in the project team; co-operate with the medical researchers, external experts and the press. In this book are answers for everything from how to handle class-effect questions to developing a shared brand vocabulary. There are plenty of vivid examples and real-life applications to reinforce the ideas. Cases studies illustrate solutions to problems; checklists and tips will help to implement the suggestions and recommendations. Gunter Umbach has distilled the essence both of 25 years' experience in the healthcare market and of his highly successful seminar series on marketing clinical trials into the professional advice given in this book. The text is accompanied by a CD ROM containing detailed Powerpoint slides supporting e

Antioxidants Effects in Health: The Bright and the Dark Side examines the role that antioxidants play in a variety of health and disease situations. The book discusses antioxidants' historical evolution, their oxidative stress, and contains a detailed approach of 1) endogenous antioxidants, including endogenous sources, mechanisms of action, beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies; 2) synthetic antioxidants, including sources, chemistry, bioavailability, legal status, mechanisms of action, beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies; and 3) natural antioxidants, including sources, chemistry, bioavailability, mechanisms of action, possible prooxidant activity; beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies. Throughout the boo, the relationship of antioxidants with different beneficial and detrimental effects are examined, and the current controversies and future perspectives are addressed and explored. Antioxidants Effects in Health: The Bright and the Dark Side evaluates the current scientific evidence on antioxidant topics, focusing on endogenous antioxidants, naturally occurring antioxidants and synthetic antioxidants. It will be a helpful resource for pharmaceutical scientists, health professionals, those studying natural chemistry, phytochemistry, pharmacognosy, natural product synthesis, and experts in formulation of herbal and natural pharmaceuticals.

What's the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.

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.

From prolonged duration of a disease, to permanent injury, to death, drug shortages have led to harmful outcomes for patients of all ages. Over the last decade, an increasing number of prescription drugs -- including life-saving and life-sustaining drugs -- have been in short supply, preventing health care providers and patients from accessing medications that are essential for treatment. During shortages, providers -- including hospitals, physicians, and pharmacists -- may have to use medications that could be less effective for treating conditions or carry unwanted side-effects, if alternatives are available at all. The immediate cause of drug shortages can generally be traced to a manufacturer halting or slowing production to address quality problems, triggering a supply disruption. Other manufacturers have a limited ability to respond to supply disruptions due to constrained manufacturing capacity. This book reviews the trends in recent drug shortages and describes what is known about their effect on patients and providers; examines the causes of drug shortages; and evaluates the progress FDA has made in addressing drug shortages.

Can academia save the pharmaceutical industry? The pharmaceutical industry is at a crossroads. The urgent need for novel therapies cannot stem the skyrocketing costs and plummeting productivity plaguing R&D, and many key products are facing patent expiration. Dr. Rathnam Chaguturu presents a case for collaboration between the pharmaceutical industry and academia that could reverse the industry's decline. Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships provides insight into the potential synergy of basing R&D in academia while leaving drug companies to turn hits into marketable products. As Founder and CEO of iDDPartners, focused on pharmaceutical innovation, Founding president of the International Chemical Biology Society, and Senior Director-Discovery Sciences, SRI International, Dr. Chaguturu has assembled a panel of experts from around the world to weigh in on issues that affect the two driving forces in medical advancement. * Gain global perspectives on the benefits and potential issues surrounding collaborative innovation * Discover how industries can come together to prevent another "Pharma Cliff" * Learn how nonprofits are becoming the driving force behind innovation * Read case studies of specific academia-pharma partnerships for real-life examples of successful collaboration * Explore government initiatives that help foster cooperation between industry and academia Dr. Chaguturu s thirty-five years of experience in academia and industry, managing new lead discovery projects and forging collaborative partnerships with academia, disease foundations, nonprofits, and government agencies lend him an informative perspective into the issues facing pharmaceutical progress. In Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships, he and his expert team provide insight into the various nuances of the debate.

As the scope of available drug therapies expands, spending on prescription drugs has become the fastest-growing category of total spending on health care in the United States. Recently, that growth has slowed and that slowdown reflects changes in both the supply and demand for prescription drugs. This book examines the innovation, development and complexity issues present in the pharmaceutical industry.

This volume fills an important need for understanding about the interplay between China's intellectual property protection system and the potential for innovation in China's economy. Using examples from the pharmaceutical and biotech industries, the author suggests that, despite the widely documented challenges facing China's IPR protection system, the system has a demonstrable effect on innovation. The author suggests that China's patent system promotes innovation through economic incentives, soft factors of public encouragement, and intentional development strategies. This book is also useful as an overview of China's biotech and pharmaceutical sectors, offering a range of richly detailed case studies on China's industrial development strategies in these sectors. A number of important patent disputes between Chinese and foreign companies are also examined to useful effect. In the highly contentious policy world of intellectual property protection and pharmaceutical and biotech industry development, the volume offers a refreshing combination of detail and insight.'uPitman B. Potter, University of British Columbia, Canada'Yahong Li's pioneering study, Imitation to Innovation in China, breaks new ground in closely examining the extent to which the Chinese government's patent policies and patent activity by Chinese firms are influencing China's coming transformation from an imitation-oriented country to an innovation-oriented one. Her combination of theoretical and empirical approaches exploring the links between public policy, patenting activity and technological innovation (commercialization) is an important contribution to development studies, not just for China but for other newly innovative countries as well.'uWilliam O. Hennessey, Franklin Pierce Law Center, USA Following decades in which China's approach to technology has been to imitate, the country is now transforming itself to become innovation-oriented. This pioneering study examines whether patents play as similar a role in promoting innovation in China as they do in the West, exploring the interplay between patents and China's biotechnology and pharmaceutical industries in particular. The author argues for a stronger patent regime based on an extensive review of the technological capacity, R&D models, patent filings and litigations, and issues in patent law, which involve China's biotechnology and pharmaceutical industries. By comparing China with other developing countries and analyzing China's uniqueness in terms of its development stage, technological capacity and the strengths and weaknesses in its patent system, the author concludes that China is distinguished from the prevailing view that patents play a limited role in innovation in developing countries. The book also discusses whether and how patents can promote innovation in China's biotechnology and pharmaceutical industries, based on the study of market scale, R&D capacity, innovation model and patent legislation and cases.

Written by Lawton R. Burns and a panel of expert contributors, from the prestigious Wharton School, The Health Care Value Chain analyzes the key developments and future trends in the United States' health care supply chain. Based on a groundbreaking research initiative underwritten by the industry/university consortium— the Center for Health Management Research— this important book offers an in-depth examination of how the health care supply chain helps create value and competitive advantage.
The Health Care Value Chain offers a thorough examination of the trading relationships among the manufacturers of health care products, the distributors, the group purchasing organizations, and the hospital customers and end users of those products. And the authors show how health care professionals and manufacturers can work together to form beneficial strategic alliances.

"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 book provides evidence to support the health-promoting components of green tea for human health. It explores the significance of green tea and its catechins represented by epigallocatechin gallate (EGCG), demonstrating their beneficial effects on diseases including cancer, obesity, arteriosclerosis, diabetes, hepatitis, and neurodegenerative diseases. The present status of human studies and avenues for future research are discussed. It is written by a team of experts from across the globe and makes significant Japanese findings available to international researchers. It is an essential resource for researchers interested in the biochemistry and pharmacology of green tea, and functional foods and beverages.

Alzheimer's Disease (AD) is a growing global public health challenge. The development of new therapies is urgently needed, and a complex ecosystem of organizations has grown to facilitate AD drug discovery and development. Masterfully collating information on the drug development ecosystem, this book emphasizes the contributions of each aspect in the pipeline with a uniform approach to chapters, enabling readers to access relevant information quickly. Topics covered include the use of non-clinical laboratory studies, biomarker development, artificial intelligence, design and management of clinical trials, and funding and financing models. Also discussed is the critical role of advocacy fundraising for drug development. With the approval of aducanumab, the function of the ecosystem has become apparent. This is a definitive overview of how the ecosystem works in transferring an AD drug from its discovery in the laboratory through clinical trial testing to regulatory review and eventual marketing.

The development and marketing of drugs since the Second World War offers an exemplary demonstration of the impact of technology on competitiveness in a major industry. While focusing primarily on the market in the USA, this study examines also the activities of European firms, their contribution to the industry's technological evolution and the impact of their entry into the US market.

The main concern of the book, however, is to examine all the elements which go to make up the evolving landscape of competition, and their interaction. Thus, the effects of technological change are viewed in the context of changes in the legal and regulatory environment, and in competitive practice. For both the market as a whole and the individual firm this analysis illustrates how competitive positions actually emerge as a result of such interactions.

Consistent with this wider view, both the technological and the non-technological competencies of firms are discussed, and the concept of core competence is used extensively to show how individual firms developed and maintained their competitive strengths, as the industry moved from deep-tank fermentation through to the first decade of biotechnology. The final chapter highlights the key role of biotechnology in shaping the future of the industry, at a time of increased regulation and accelerating market driven change.

Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation. The benefit to Society is self-evident in that affordable treatments would be rapidly forthcoming. We have aggregated these phenomena into one topic "Pharmaco-complexity: Non-linear Phenomena and Drug Product Development".

The pharmaceutical industry has long and vehemently insisted that it has the willingness, the dedication, and the ability to police itself to insure that the public will not be unnecessarily harmed or defrauded. As the record shows with painful clarity, however, virtually no industry or professional group has ever adequately policed itself, and the pharmaceutical industry is no exception. Where the most flagrant abuses have been exposed and corrected, major credit must probably be divided among the media that publicized the situation, consumer groups that applied pressure, government officials who took actions that were often unpopular, and individual members of the pharmaceutical industry who had the courage to face up to their social responsibilities.
In this book, the authors turn their attention to what happened in Third World countries when, because of worldwide pressures, the multinational drug companies largely corrected their notorious abuses. On the basis of painstaking research, much of it conducted in a great many Third World countries, the authors conclude that a plethora of small local firms have filled the dishonest sales channels vacated by the multinationals. The authors show in great detail how local drug firms in the Third World have taken advantage of loose regulatory practices and unscrupulous behavior on the part of regional and national health care professionals to promote the sale of dangerous or worthless drugs as remedies for diseases for which they were never intended. Warnings of bad side effects are omitted from promotional literature, drugs are sold that have not had proper trials, and drug firms have often bribed government officials, doctors, and hospital administrators in order to gain favorable treatment in the importation and sale of their products. Among the many topics treated in this book are the controversy over inexpensive generic drugs (including disclosures of fraud and bribery in the U.S. Food and Drug Administration), the actions of consumer groups, and the key role of government in preventing abuses by drug firms. The authors describe a remarkable attempt in Bangladesh, one of the poorest of all the developing countries, to develop a high-quality local drug industry. They also present as case histories reports on three extremely important drug products or groups--the dipyrones (for control of pain and fever), high-dosage estrogen-progesterone hormone products (for use in pregnancy tests), and clioquinol or Enterovioform (for treatment of diarrhea)--all of which were or still are centers of worldwide, heated controversy.

Five years after publication of the third edition, and reflecting the dynamic nature of the pharmaceutical and medical device industries (as well as the many different areas of law that pertain to the management of these medical technologies), the Fourth Edition incorporates the latest legislative, regulatory, and judicial developments, describes recent scientific advances, and excerpts or references new scholarly contributions to this broad field (the wealth of citations should facilitate use in a seminar setting). Measured by volume, more than 20% of the previous edition has been replaced with new material. The latest edition retains the same basic thematic approach and modular structure of the original, which allows instructors to pick and choose the materials to cover based on their own tastes and areas of expertise.

Most people marvel at the level of innovation demonstrated by the biopharmaceutical industry in bringing new products to the market - especially in the past 20 years. However, there is a crisis looming in the industry that should be a concern to all of us who take for granted the constant pace at which new treatments, and increasingly cures, have emerged from the laboratories of current sector incumbents. In the book, we examine the evolution of the biopharmaceutical industry to understand how it became what we term a "unicorn industry" with a unique, US-centered business model that has led to multiple blockbuster products (aka, unicorns) year after year. We explore how past success has created perceived barriers to innovation diversification beyond the chemical or biological-based biopharmaceutical product, and highlight the warning signs of the industry's decline. We define a potential pathway for transforming the industry's business model by broadening the definition, sources, and enablers of innovation beyond the traditional biopharmaceutical product. We introduce and advocate for the 80-80 Rule - "Being 80% confident that you will only be 80% right the first time should feel normal." The 80-80 Rule is a theme that emphasizes speed and willingness to embrace uncertainty and overcome internal barriers to change. It sets the standard for redefining innovation as a platform to reignite growth of the biopharmaceutical industry.

Power Recruiting unfolds the mystery of how to effectively recruit for every industry. Diana Y. Ji is the founder and president of Bongene Search, an executive search firm dedicated to handling critical talent search needs in the biopharma industry. In Power Recruiting, she brings her twenty years of experience in corporate talent acquisition and executive search fields to teach hiring managers and recruiting professionals: The key to finding top talents and getting them onboard How to identify a good hire and avoid the bad ones The best strategies to make their company more attractive to potential hires Guarantee a successful hire every time Tips to getting ahead in the hiring game

Smart Polymeric Nano-Constructs in Drug Delivery: Concept, Design and Therapeutic Applications provides a thorough discussion of the most state of the art material and polymer exploitations for the delivery of bioactive(s) as well as their current and clinical status. The book enables researchers to prepare a variety of smart drug delivery systems to investigate their properties as well as to discover their uses and applications. The novelty of this approach addresses an existing need of exhaustively understanding the potential of the materials including polymeric drug delivery systems that are smartly designed to deliver bioactive(s) into the body at targeted sites without showing side effects. The book is helpful for those in the health sector, specifically those developing nanomedicine using smart material-based nano-delivery systems. Polymers have unique co-operative properties that are not found with low-molecular-weight compounds along with their appealing physical and chemical properties, constituting the root of their success in drug delivery. Smart Polymeric Nano-Constructs in Drug Delivery: Concept, Design and Therapeutic Applications discusses smart and stimuli responsive polymers applicable in drug delivery, followed detailed information about various concepts and designing of polymeric novel drug delivery systems for treatment of various type of diseases, also discussing patents related to the field. The book helps readers to design and develop novel drug delivery systems based on smart materials for the effective delivery of bioactive that take advantage of recent advances in smart polymer-based strategies. It is useful to those in pharmaceutical sciences and related fields in developing new drug delivery systems.