The last two decades have seen great economic change in Asia and this has impacted upon the vexed question of access to affordable healthcare and medicines in many Asian states. In this book Locknie Hsu examines the issue of access to medicines in Asia from a fresh perspective which embraces trade and investment law, innovation, intellectual property law, competition policy and public health issues. Hsu explores the key evolving legal issues in these areas, including ASEAN integration, free trade agreement negotiations (such as those for the TPP), bilateral investment agreements and significant court decisions. The book goes on to present proposals for steps to be taken in addressing access to medicines in Asia and will be useful to academic researchers, regulators, law-makers and global organizations involved in the issues surrounding access to affordable healthcare and medicines.

The last two decades have seen great economic change in Asia and this has impacted upon the vexed question of access to affordable healthcare and medicines in many Asian states. In this book Locknie Hsu examines the issue of access to medicines in Asia from a fresh perspective which embraces trade and investment law, innovation, intellectual property law, competition policy and public health issues. Hsu explores the key evolving legal issues in these areas, including ASEAN integration, free trade agreement negotiations (such as those for the TPP), bilateral investment agreements and significant court decisions. The book goes on to present proposals for steps to be taken in addressing access to medicines in Asia and will be useful to academic researchers, regulators, law-makers and global organizations involved in the issues surrounding access to affordable healthcare and medicines.

As business processes are crucial success factors for companies, software-based Business Process Management (BPM) is becoming more and more important. In this area SAP, the market leader for enterprise application software, has already gathered substantial experience. For the characterization, modeling and especially the optimization of business processes, SAP’s consultants use their own BPM approach. In addition to their considerable methodological know-how, the consultants’ profound knowledge of the industries facilitates the focus on core and business-critical processes. This book examines the current market situation, as well as the specific challenges and trends for the chemical and pharmaceutical industries. It also explains business process management basics and the specific SAP Consulting methodology, before illustrating the use of such methods and procedures with sample industry-specific core business processes. With the help of these examples from the chemical and pharmaceutical industries, SAP Consulting provides methodological guidelines on how Business Process Management can be used in practice to optimize business processes and make adjustments in response to constantly changing economic and environmental factors.

This book is a complete, authoritative resource on the coating of tablets, capsules, and other solid dosage forms of therapeutic agents. Fourteen authors cover the industry's technologies. The book begins with a full discussion of the primary processes -- sugar coating, film coating, and microencapsulation -- as well as the rationale for coating, methodologies, formulations, processing methods, and equipment and cleaning. Then it explores automation of the coating process, including hardware and software requirements. Finally, the book examines major stability and quality control issues. Regulations underlie all discussions.

In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest - with the most up to date research updates - in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

The pharma and medtech sectors are evolving rapidly, driven by science, technology, economics, politics and globalization. In the new industry landscape, creating strong brand strategies is ever more difficult and ever more vital. Brand Therapy gives pharma and medtech brand teams the tools to understand their market, create strong strategies and translate them into actionable plans. Written in 16 short, easy chapters, it is essential reading for anyone who works in or with brand teams in the life sciences industry.

The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region. ​        

This book explains how government support and institutional set up facilitated the evolution of the Indian pharmaceutical industry and provides an economic analysis of firm strategies due to recent policy changes. The book is useful for researchers interested in understanding the transition of a lifeline sector for an emerging economy like India. Students of public policy, health administrators and health economists who are interested in the functioning of the pharmaceutical sector that produces life saving drugs in developing nations will find this book useful. The book also provides good coverage on data envelopment analysis (DEA), a useful technique for understanding productivity and efficiency. It can provide guidance to the research students on the applicability of DEA technique to address various research questions for analysis. The book will be a valuable addition to libraries in colleges of pharmacy and medicine as well as to all other academic and research centers.

This book critically investigates the patent protection of medication in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter "SSA" or "Africa"). The book outlines the systemic problems associated with the prevailing globalized patent regime and the regime's inability to promote access to life-saving medication at affordable prices in SSA. It argues that for pharmaceutical patents to retain their relevance in SSA countries, human development concepts must be integrated into global patent law- and policy-making. An integrative approach implies developing additional public health and human development exceptions/limitations to the exercise of patent rights with the goal of scaling up access to medication that can treat epidemics in SSA. By drawing on multiple perspectives of laws, institutions, practices, and politics, the book suggests that SSA countries adopt an evidence-based approach to implementing global patent standards in domestic jurisdictions. This evidence-based approach would include mechanisms like local need assessments and the use of empirical data to shape domestic patent law-making endeavors. The approach also implies revising patent rules and policies with a pro-poor and pro-health emphasis, so that medication will be more affordable and accessible to the citizens of SSA countries. It also suggests considering the opinions of individuals and pro-access institutions in enacting crucial pieces of health-related statutes in SSA countries. The approach in this book is sensitive to the public health needs of the citizens affected by epidemics and to the imperative of building local manufacturing facilities for pharmaceutical research and development in SSA.

Our recent understanding of the cellular and molecular defects and the regulation of the apoptotic signalling pathways has resulted in rationally designed anticancer strategies and the development of novel agents that regulates apoptosis. A comprehensive review of all apoptotic-related anticancer therapies is not the purpose of this book. However, in the volume of this book with 11 chapters, we have described a number of novel apoptotic regulators that have shown promising value and also great feasibility for cancer treatment. These novel agents either occur naturally or are chemically synthesized. While we are excited about the discovery and development of these novel apoptotic regulators as potential anticancer agents, a degree of caution should be always borne in mind when interpreting the success of preclinical pro-apoptotic candidates since potential problems inevitably lie ahead. These problems usually include target specificity, unanticipated toxicity, compound stability, formulation issues, pharmacokinetic and pharmacodynamic profiles. Nevertheless, we believe that this collection of 11 chapters by established leaders in the area of apoptosis will be of great interest to not only academics working in the field of cancer research and apoptosis but also pharmaceutical and pharmacological industries that . We are looking forward to the further development to push these potential agents toward clinical stage.

Combination Therapy against Multidrug Resistance explores the potential of combination therapy as an efficient strategy to combat multi-drug resistance. Multidrug resistance (MDR) occurs when microorganisms such as bacteria, fungi, viruses, and parasites are excessively exposed to antimicrobial drugs such as antibiotics, antifungals, or antivirals, and in response the microorganism undergoes mutations or develops different resistance mechanisms to combat the drug for its survival. MDR is becoming an increasingly serious problem in both developed and developing nations. Bacterial resistance to antibiotics has developed faster than the production of new antibiotics, making bacterial infections increasingly difficult to treat, and the same is true for a variety of other diseases. Combination therapy proves to be a promising strategy as it offers potential benefits such as a broad spectrum of efficacy, greater potency than the drugs used in monotherapy, improved safety and tolerability, and reduction in the number of resistant organisms. This book considers how combination therapy can be applied in multiple situations, including cancer, HIV, tuberculosis, fungal infections, and more. Combination Therapy Against Multidrug Resistance gathers the most relevant information on the prospects of combination therapy as a strategy to combat multridrug resistance and helping to motivate the industrial sector and government agencies to invest more in research and development of this strategy as a weapon to tackle the multidrug resistance problem. It will be useful to academics and researchers involved in the development of new antimicrobial or antiinfective agents and treatment strtategies to combat multidrug resistance. Clinicians and medical nurses working in the field of infection prevention and control (IPC) will also find the book relevant

Ernest Solvay, philanthropist and organizer of the world-famous Solvay conferences on physics, discovered a profitable way of making soda ash in 1861. Together with a handful of associates, he laid the foundations of the Solvay company, which successfully branched out into other chemicals, plastics and pharmaceuticals. Since its emergence in 1863, Solvay has maintained world leadership in the production of soda ash. This is the first scholarly book on the history of the Solvay company, which was one of the earliest chemical multinationals and today is among the world's twenty largest chemical companies. It is also one of the largest companies in the field to preserve its family character. The authors analyze the company's 150-year history (1863-2013) from economic, political and social perspectives, showing the enormous impact geopolitical events had on the company and the recent consequences of global competition.

Bernadette Gral examines the relationship between financial slack and corporate performance in the European pharmaceutical industry during the financial crisis of 2007 to 2010. Her investigation includes correlational and regression analyses as well as the qualitative content analysis of newspaper articles. The results show that financial slack influences corporate performance measured as ROA based on net income, thus implying that firms use slack resources to enhance performance during crises. The findings support the arguments for a beneficial effect of financial slack on performance according to the resource based view and behavioral theory of the firm.

Originally published in 1992, this study of Glaxo, from its beginnings to 1962, was based on unprecedented and unparalleled archival access to the company records. It gives a detailed account of the global operations of Glaxo, and describes not only the evolution of its international business, but studies its research and development programmes, its products, and its marketing and management. It was the first comprehensive study of a UK-based drugs company and one of the relatively few scholarly studies written of front-ranking world companies.

PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the pharmaceutical industries and their charade of fraudulent behaviour, both in research and marketing where the morally repugnant disregard for human lives is the norm. He convincingly draws close comparisons with the tobacco conglomerates, revealing the extraordinary truth behind efforts to confuse and distract the public and their politicians. The book addresses, in evidence-based detail, an extraordinary system failure caused by widespread crime, corruption, bribery and impotent drug regulation in need of radical reforms. "The main reason we take so many drugs is that drug companies don't sell drugs, they sell lies about drugs. This is what makes drugs so different from anything else in life...Virtually everything we know about drugs is what the companies have chosen to tell us and our doctors...the reason patients trust their medicine is that they extrapolate the trust they have in their doctors into the medicines they prescribe. The patients don't realise that, although their doctors may know a lot about diseases and human physiology and psychology, they know very, very little about drugs that hasn't been carefully concocted and dressed up by the drug industry...If you don't think the system is out of control, please email me and explain why drugs are the third leading cause of death...If such a hugely lethal epidemic had been caused by a new bacterium or a virus, or even one-hundredth of it, we would have done everything we could to get it under control." FROM THE INTRODUCTION

"Polymorphism in the Pharmaceutical Industry - Solid Form and Drug Development" highlights the relevance of polymorphism in modern pharmaceutical chemistry, with a focus on quality by design (QbD) concepts. It covers all important issues by way of case studies, ranging from properties and crystallization, via thermodynamics, analytics and theoretical modelling right up to patent issues. As such, the book underscores the importance of solid-state chemistry within chemical and pharmaceutical development. It emphasizes why solid-state issues are important, the approaches needed to avoid problems and the opportunities offered by solid-state properties. The authors include true polymorphs as well as solvates and hydrates, while providing information on physicochemical properties, crystallization thermodynamics, quantum-mechanical modelling, and up-scaling. Important analytical tools to characterize solid-state forms and to quantify mixtures are summarized, and case studies on solid-state development processes in industry are also provided. Written by acknowledged experts in the field, this is a high-quality reference for researchers, project managers and quality assurance managers in pharmaceutical, agrochemical and fine chemical companies as well as for academics and newcomers to organic solid-state chemistry.

"This fascinating and most timely critical medical anthropology study successfully binds two still emergent areas of contemporary anthropological research in the global world: the nature and significant impact of multinational pharmaceutical manufacturers on human social life everywhere, and the contribution of corporations to the fast-paced degradation of our life support system, planet Earth. . . . Focusing on a pharmaceutically-impacted town on the colonized island of Puerto Rico, Dietrich ably demonstrates the value of ethnography carried out in small places in framing the large issues facing humanity." -Merrill Singer, University of Connecticut The production of pharmaceuticals is among the most profitable industries on the planet. Drug companies produce chemical substances that can save, extend, or substantially improve the quality of human life.However, even as the companies present themselves publicly as health and environmental stewards, their factories are a significant source of air and water pollution--toxic to people and the environment. In Puerto Rico, the pharmaceutical industry is the backbone of the island's economy: in one small town alone, there are over a dozen drug factories representing five multinationals, the highest concentration per capita of such factories in the world. It is a place where the enforcement of environmental regulations and the public trust they ensure are often violated in the name of economic development. The Drug Company Next Door unites the concerns of critical medical anthropology with those of political ecology, investigating the multi-faceted role of pharmaceutical corporations as polluters, economic providers, and social actors. Rather than simply demonizing the drug companies, the volume explores the dynamics involved in their interactions with the local community and discusses the strategies used by both individuals and community groups to deal with the consequences of pollution. The Drug Company Next Door puts a human face on a growing set of problems for communities around the world. Accessible and engaging, the book encourages readers to think critically about the role of corporations in everyday life, health, and culture.

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'sMonumental Imagination combines literary analysis and cultural criticism for a long neglected aspect of our nation's iconic development in statuary.

Physician-pharmaceutical industry interactions continue to generate heated debate in academic and public domains, both in the United States and abroad. Despite this, recent research suggests that physicians and physicians-in-training remain uninformed of the core issues and are ill-prepared to understand pharmaceutical industry promotion. Furthermore, few medical curricula address this issue, despite warnings of the imperative need to address this gap in the education of tomorrow's physicians. There is a vast medical literature on this topic, but no single, concise resource. This book aims to fill that gap by providing a resource that explains the essential elements of this subject. The text makes the reader more aware of the key ethical issues and allows the reader to be a more savvy interpreter of industry promotion, have a heightened awareness of the public and medical legal consequences of some physician-pharmaceutical industry interactions, and be better equipped to handle real-life encounters with industry.

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.

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 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.

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.