Covers advances in particulate drying and its importance in the process industry Highlights recent developments in conventional drying techniques and new drying technologies Helps readers gain insight into selecting the appropriate drying techniques for a particular product Summarizes various applications from a wide range of industries, including chemical, food, pharma, biotech, polymer, mineral, and agro-industries Envisages future research trends and demands in particulate drying

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

This book discusses and chronicles various types of manufacturing processes, including casting and molding, machining, joining, shearing, and forming. It refers to repetitive, discrete, job shop, process manufacturing (continuous), and process manufacturing (batch). It also offers detailed examples from the nuclear, electronic, plastics, adhesives, inks, packaging, chemical, and pharmaceutical industries. Advanced Manufacturing Operations Technologies: Principles, Applications, and Design Correlations in Chemical Engineering Fields of Practice fills the gap in the connection between production and regulated applications in several industries. It highlights established concepts and provides a new fresh outlook by concentrating on and creating linkages in the implementation of practices in manufacturing and safe clean energy systems. Case studies for the overall design, installations, and construction of manufacturing operations in various industries as well as the standard operating procedures are offered. The book also discusses the correlation between design strategies including step-by-step processes to ensure the reliability, safety, and efficacy of products. The fundamentals of controlled techniques, quality by design, risk assessment, and management are covered in support of operations applications and continuous improvement. This comprehensive book is helpful to all professionals, students, and academicians in many scientific disciplines that utilize fundamental principles of chemical engineering. It is engineering-driven and will be of use to those in industrial and manufacturing, chemical, biochemical, mechanical engineering, and automated control systems fields.

Americans seeking herbal medicines now face confusion and even danger. There is great potential for these medicines to improve the health of consumers--if current regulations can be revised!Herbal Medicine: Chaos in the Marketplace is a prize-winning critique of the regulation and business of herbal medicine in the United States. It is the first book that examines the big picture issues-it tells the story of how the present situation developed, looks at what it means for consumers, compares approaches taken in other industrialized countries, and recommends where we need to go from here. Convenient reference tables provide easy access to information.Concerns about herbal medicines are hitting the headlines regularly, yet no other book has examined the core issues in depth from a public health perspective. Herbal Medicine: Chaos in the Marketplace fills that gap. It is highly relevant today, and you'll find it will continue to be indispensable reading for years to come as the situation plays out.This balanced, unique, and insightful volume will add to your knowledge of herbal medicine regulation and its impact on consumer health by: framing the limitations of the current situation with brief examples reviewing the regulatory history of herbal medicines in the United States placing the situation in an international context by also examining regulations in Canada, Germany, France, and the United Kingdom illustrating the practical implications of U.S. regulations with six examples that demonstrate how herbal medicines could contribute more to consumer health--and the public health risks associated with the current regulatory situation analyzing the public health issues related to safety, research, clinical practice, consumer interests, business, media, and federal government offering key, high-impact recommendations for future policyConsumers, health care professionals, business people in the domestic and foreign herb industries, researchers, health plan executives, food and drug attorneys and policymakers, as well as educators and students, will all find this book essential to their understanding of the workings of the herbal medicine industry. Visit the author's website at http://www.herbalchaos.com

Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators. Contributors: R. Arnold, M.A. Bagley, B. Domeij, J. Drexl, R.C. Dreyfuss, C.R. Fackelmann, T. Imura, R. Iseki, N. Lee, R. Moufang, H. Ullrich

Pharmaceutical Economics begins with an investigation of the structure of the industry and its three main components: the research firms which produce innovative products; the generic drug industry and its expanding role; and the biotech industry, which is regarded as the future for pharmaceuticals. Further sections discuss topics including demand and incentives, pricing and regulation. Professor Comanor and Professor Schweitzer have selected the most significant articles by leading academics, in order to offer a blend of standard economic interpretations of pharmaceutical policy and important new topics including biosimilars, insurance coverage for pharmaceuticals, price-fixing and direct-to-consumer advertising. An authoritative new introduction by the editors provides an insightful guide to these important topics.

The world production of citrus fruit has risen enormously in the last few decades, leaping from forty-five million tons a year in the early 1970's to eighty-five million in the season of 1996-1997. More than thirty per cent of these fruits go into industrial production in which essential oils and juice are the principal products. The main applications of essential oils are as flavourings for alcohol, soft drinks, food, pharmaceutical products and as fragrances for cosmetics and beauty products. Today, the potential applications of these essential oils are growing wider because they are environmentally 'safer' than the petrochemical products they can sometimes replace.
This book offers comprehensive coverage on all aspects of the botany, cultivation, processing industry, chemistry and uses of Citrus and its oils. Anyone involved in food sciences, pharmaceutical sciences, cosmetics, pharmacy and plant sciences will no doubt find this volume to be of great value and interest.

eBook available with sample pages: 020321661X

India is the largest provider of generic drugs globally. The Indian pharmaceutical sector supplies over 50 per cent of the global demand for various vaccines, and as a result, holds an important position in the global pharmaceutical sector. This book is a comprehensive study of pharmaceutical marketing management in the Indian context and similar growth markets. The book introduces the fast-paced and multi-faceted discipline of pharmaceutical marketing management through an in-depth discussion on the genesis and evolution of its marketing concept. Combining theory and practice, it offers a strategic approach to pharmaceutical marketing from an organisational and business perspective and explicates the practical applications of it. Richly supported by case studies, the book brings together fresh perspectives and approaches equally useful for students and professionals. This book will be of interest to academicians, advanced students, and practitioners of pharmaceutical marketing and pharmaceutical management. It will also be beneficial to those interested in business strategy, decision making, and international marketing.

Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering.

Multicultural Pharmaceutical Education spotlights methods and theory on how to increase representation of minorities in pharmacy schools and practice settings. Many of the ideas presented in this book are unique, and all provide an opportunity for institutions with few minority students to greatly improve their recruitment and retention efforts geared toward these students. The contributing authors, representing all levels of academia--deans, undergraduate students, vice provosts, executive directors, a National Professor of the Year, and faculty members--have all had experience in some aspect of minority pharmaceutical education. It is through their practical experiences that they offer suggestions and commentary on pharmacy programs of study. Historical accounts or examples of success that could be emulated at other institutions are included. With the help of Multicultural Pharmaceutical Education, colleges and universities and their faculty can forge ahead in attracting and retaining minority students to their pharmacy programs and into the world of pharmacy practice. Structured around four major areas (foundation, commitment, actuation, and conclusion), the authors remove the option of traditional excuses of failure in this important area of education. All those involved in pharmacy education should read this book whether deans, admissions counselors, professors, or students. Multicultural Pharmaceutical Education provides an easy-to-read, practical and theoretical approach to improving the opportunity and quality of education that minority students can achieve in pharmaceutical programs.

This path-breaking book addresses the ongoing implications for traditional pharmaceutical companies and biopharmaceutical start-ups of the realignment of the industry knowledge-base. The theoretical approach draws on the modern theory of the firm and related ideas in order to better define the concept of the business model, which is employed to guide the case studies and empirical analysis in the book. The author shows that while traditional pharmaceutical companies have successfully adjusted their business models to meet the challenges of biotechnology, biopharmaceutical start-ups have experienced more problems. Despite the poor financial performance of the vast majority of these firms, the biopharmaceutical sector as a whole has created significant value. However, this has been captured disproportionately by a handful of large, fully-integrated biopharmaceutical firms and, to a lesser extent, by the largest dozen pharmaceutical companies.This highly focused book will be a captivating read for innovation and biopharmaceutical industry analysts, as well as advisers formulating policies to support the development of the biopharmaceutical sector. Academics working on innovation and biotechnology, as well as scientists engaged in research in the life sciences, will also find this book of particular interest.

Trail-blazing social entrepreneurs are tackling the world's most pressing problems that government, business, or charity have failed to solve. They are creating businesses with a primary mission of social change. Scott Boyer is one such social entrepreneur. This 28-year veteran of Big Pharma left a six-figure salary to start OWP Pharmaceuticals and the ROW Foundation. This commercial business and non-profit organization exist in a symbiotic relationship we call a "tandem hybrid social enterprise." This model combines a multimillion dollar business with a foundation that's on track to become the largest funder of projects serving people with epilepsy and associated psychiatric disorders in the world. The tandem hybrid incorporates the principles learned by Scott and others for building a truly unique social enterprise from the ground up; one that is: Driven by a compelling social mission Financed by commercial success Structured to retain control Scalable and sustainable for the long haul Powering Social Enterprises With Profit And Purpose offers a detailed blueprint that has proven commercially and philanthropically successful and that can be replicated in most business sectors.

'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.

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors - states, transnational business corporations, or civil society groups - and their influence on the structures - such as national and international agreements, organizations, and private entities - that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

* provides an in-depth discussion of recent advances in sterilization * identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions * explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results * New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture.

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.

Provides a comprehensive review of challenges and opportunities as related to the applications of big data, AI, and machine learning in the entire spectrum of drug R&D Discusses regulatory developments in leveraging big data and advanced analytics in drug review and approval Offers a balanced approach to data science organization build Presents real-world examples of AI-powered solutions to a host of issues in the lifecycle of drug development Affords sufficient context for each problem and provides detailed description of solutions suitable for practitioners with limited data science expertise

This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.

The pharmaceutical industry, long thought of as a recession-proof investment, now faces a day of reckoning. The reasons for this impending downfall are not hard to discern. The prices the industry charges for its prescription drugs have escalated at four to five times the cost-of-living increases during the past two decades and have reached a point where 30% of Americans must choose between filling a prescription, paying for housing, and buying food. This has brought about public pressure on governments around the world to control drug prices, yet the world's twenty largest pharma companies realized 80% of their growth as a result of exorbitant price hikes. Pharma currently enjoys its extraordinary profitability by exploiting the world's most vulnerable populations. Yet even their ability to increase prices in the face of falling demand does not satisfy their profit demands. The breadth and depth of pharma's marketing transgressions exceed those of any other industry and have now reached a point where authorities around the world have found it necessary to take legal action against its violations. Drastic change is needed if the pharmaceutical industry can equitably advance the health of the world's population and regain public esteem. This book illustrates the range and extent of pharma's violations and addresses the actions that should be implemented in order to make the drug industry a more constructive, less venal part of contemporary society. It will be of interest to researchers, academics, practitioners, and students with an interest in the pharmaceutical industry, healthcare management, regulation, and bioethics.

Key Account Management Excellence in Pharma & Medtech is designed to help life sciences practitioners develop and execute innovative and effective key account management (KAM) strategies and capabilities. Pharmaceutical and medtech companies are increasingly pursuing KAM in response to the rapid rise of large, sophisticated and complex healthcare provider and payer systems and groups. Those that invest the time to get KAM right will protect their business and grow with these rising customers. This book is groundbreaking in both its scope and its tailoring of leading KAM practices specifically for life sciences. The central theme is that "key account management is an organization-wide business strategy, not just a role or a sales-specific initiative." KAM is a strategy focused on providing unique offerings and value through an orchestrated, cross-functional, go-to-market model designed specifically to address the needs and engagement preferences of a unique segment of customers. The insights and practices shared in this book are designed to be a valuable reference at every stage of the KAM journey. The book has been designed to facilitate a common language and deep understanding of KAM issues and leading practices organization-wide-particularly for life sciences leaders, account managers and cross-functional team members responsible for building, transforming and supporting their organization's KAM strategies and capabilities.

Offers a new perspective on "traditional" Asian medicines Provides original insights into "traditional" Asian pharmaceutical industries Broad-ranging, multidisciplinary and comparative research on Asian medicine in China, India, Japan, Mongolia, and Nepal Relevant to scholars, students, health professionals, and policy makers Includes extensive bibliographies of essential but little-known scholarship on Asian medicines from Asia

This book investigates pharmaceutical regulation and the public health issue of fake or illicit medicines in developing countries. The book analyses the evolution of pharmaceutical capitalism, showing how the entanglement of market and health interests has come to shape global regulation. Drawing on extensive fieldwork in India, Kenya, and Europe, it demonstrates how large pharmaceutical companies have used the fight against fake medicines to serve their strategic interests and protect their monopolies, sometimes to the detriment of access to medicines in developing countries. The book investigates how the contemporary dynamics of pharmaceutical power in global markets have gone on to shape societies locally, resulting in more security-oriented policies. These processes highlight the key consequences of contemporary "logistical regimes" for access to health. Providing important insights on how the flows of commodities, persons, and knowledge shape contemporary access to medicines in the developing countries, this book will be of considerable interest to policy makers and regulators, and to scholars and students across sociology, science and technology studies, global health, and development studies.

Dukes, Braithwaite and Moloney reach the depressing conclusion that 'corporate crime in the pharmaceutical industry appears to be on the rise.' Their approach to this problem is much more nuanced than just throwing people in jail. They advocate for a pyramid of regulatory strategies including qui tam legislation and equity fines. There is an opportunity for a radical transformation of the pharmaceutical industry and the authors offer us a road map to begin that journey.' - Joel Lexchin MD, York University, CanadaThe pharmaceutical industry must exist to serve the community, but over the years it has engaged repeatedly in corporate crime and anti-social behavior, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health, with deep experience of the industry, documents problems ranging from false advertising and counterfeiting to corruption, fraud and overpricing. It is a fresh and revealing look at the unacceptable pressures brought to bear on doctors, politicians, patients and the media. Uniquely, the book presents realistic and worldwide solutions for the future, with positive policies encouraging honest dealing, as well as partial privatization of enforcement and a transformation of science policy to develop the medicines that society needs most. The authors examine in turn each of the main facets of the pharmaceutical industry's activities - research, manufacturing, information, distribution and pricing - as well as some questionable aspects of its relationship with society. Offering a considered analysis of pharmaceutical rights and wrongs as they have developed, particularly over the last half-century, this book is rich in new insights for managers in the pharmaceutical industry, regulatory agencies and health agencies. Contents: Essay Part I: Setting the Scene Introduction Part II: A View of Rights and Wrongs 1. Creating a Medicine: Why, How and How Not 2. Safe, Unsafe and Improper Manufacturing Practices 3. Aggressive or Misleading Promotion 4. The Dark Art of Manipulation: The Industry and its Puppets 5. Corruption, Counterfeiting and Fraud 6. Prices, Monopolies, Abuses and the Law Part III: Transforming the Way Ahead 7. A Criminological Perspective on a Worsening Crisis 8. Positive Regulation: The Complementary Role of Supports and Sanctions 9. A Responsive Criminal Law of Pharmaceuticals 10. Privatising Enforcement 11. A New Capitalism: A New Drug Diplomacy Index