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.

"Smart, funny, clear, unflinching: Ben Goldacre is my hero." --Mary Roach, author of "Stiff," "Spook," and "Bonk
"We like to imagine that medicine is based on evidence and the results of fair testing and clinical trials. In reality, those tests and trials are often profoundly flawed. We like to imagine that doctors who write prescriptions for everything from antidepressants to cancer drugs to heart medication are familiar with the research literature about these drugs, when in reality much of the research is hidden from them by drug companies. We like to imagine that doctors are impartially educated, when in reality much of their education is funded by the pharmaceutical industry. We like to imagine that regulators have some code of ethics and let only effective drugs onto the market, when in reality they approve useless drugs, with data on side effects casually withheld from doctors and patients.
All these problems have been shielded from public scrutiny because they are too complex to capture in a sound bite. Ben Goldacre shows that the true scale of this murderous disaster fully reveals itself only when the details are untangled. He believes we should all be able to understand precisely how data manipulation works and how research misconduct in the medical industry affects us on a global scale.
With Goldacre's characteristic flair and a forensic attention to detail, "Bad Pharma "reveals a shockingly broken system in need of regulation. This is the pharmaceutical industry as it has never been seen before.

This work examines an increasingly 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 now 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.

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.

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.

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

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.

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.

The fascinating story of Tamiflu's development and stockpiling against global health threats.orld's most prominent medical countermeasure, Tamiflu. A pill can strengthen national security? The suggestion may seem odd, but many states around the world believe precisely that. Confronted with pandemics, bioterrorism, and emerging infectious diseases, governments are transforming their security policies to include the proactive development, acquisition, stockpiling, and mass distribution of new pharmaceutical defenses. What happens-politically, economically, and socially-when governments try to protect their populations with pharmaceuticals? How do competing interests among states, pharmaceutical companies, regulators, and scientists play out in the quest to develop new medical countermeasures? And do citizens around the world ultimately stand to gain or lose from this pharmaceuticalization of security policy? Stefan Elbe explores these complex questions in Pandemics, Pills, and Politics, the first in-depth study of the world's most prominent medical countermeasure, Tamiflu. Taken by millions of people around the planet in the fight against pandemic flu, Tamiflu has provoked suspicions about undue commercial influence in government decision-making about stockpiles. It even found itself at the center of a prolonged political battle over who should have access to the data about the safety and effectiveness of medicines. Pandemics, Pills, and Politics shows that the story of Tamiflu harbors deeper lessons about the vexing political, economic, legal, social, and regulatory tensions that emerge as twenty-first-century security policy takes a pharmaceutical turn. At the heart of this issue, Elbe argues, lies something deeper: the rise of a new molecular vision of life that is reshaping the world we live in.

The Price of Global Health is a unique book that describes the pharmaceutical pricing process and its business, economic and social challenges. Global drug pricing is one of the most hotly debated yet least understood aspects of the pharmaceutical industry. How should drug prices be set and what does it mean for patients? Why do governments increasingly get involved, and what is its impact on the global competitive environment? How can a life-saving industry have a poorer image than gun and tobacco industries, whose products are associated with death? The pharmaceutical industry is under unprecedented pressure due to a combination of declining R&D productivity, payer/provider demands for better value and public pressures to show pricing restraint. Rapidly increasing cost of healthcare, shifts from fee-for-service to value-based reimbursement, public pressure on drug pricing and an increasingly vocal medical community have empowered public and private payers worldwide to be more demanding on evidence of value for the prescription drugs that are brought to market. Pharmaceutical companies have often failed to deliver evidence of patient value, as development decision-making is overly focused on speed to FDA approval rather than speed to commercial success by effectively addressing the many "Access Journey" obstacles that typify today's much changed pharmaceutical environment. This 3rd edition is significantly expanded with ten new chapters and revised and updated throughout to reflect today's environment. The contents are reorganized to directly address critical pricing and patient access issues. Ed Schoonveld explains how pharmaceutical prices are determined in a complex global payer environment and what factors influence the process. His insights will help a wide range of audiences from healthcare industry professionals to policy makers, consumers, pharmaceutical company leaders and access and pricing professionals to gain a better understanding of this highly complex and emotionally charged field.

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

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.

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

Give and Take looks at local drug manufacturing in Kenya, Tanzania, and Uganda, from the early 1980s to the present, to understand the impact of foreign aid on industrial development. While foreign aid has been attacked by critics as wasteful, counterproductive, or exploitative, Nitsan Chorev makes a clear case for the effectiveness of what she terms "developmental foreign aid." Against the backdrop of Africa's pursuit of economic self-sufficiency, the battle against AIDS and malaria, and bitter negotiations over affordable drugs, Chorev offers an important corrective to popular views on foreign aid and development. She shows that when foreign aid has provided markets, monitoring, and mentoring, it has supported the emergence and upgrading of local production. In instances where donors were willing to procure local drugs, they created new markets that gave local entrepreneurs an incentive to produce new types of drugs. In turn, when donors enforced exacting standards as a condition to access those markets, they gave these producers an incentive to improve quality standards. And where technical know-how was not readily available and donors provided mentoring, local producers received the guidance necessary for improving production processes. Without losing sight of domestic political-economic conditions, historical legacies, and foreign aid's own internal contradictions, Give and Take presents groundbreaking insights into the conditions under which foreign aid can be effective.

Using clear and practical examples, Polymorphism in Pharmaceutical Solids, Second Edition presents a complete examination of polymorphic behavior in pharmaceutical development.
Ideal for pharmaceutical development scientists and graduate students in pharmaceutical science, this updated edition includes:
NEW CHAPTERS - on the latest developments and methods in the field that give pharmaceutical development scientists the up-to-date information they need to successfully implement new drug development techniques and methods
EXPERT EDITORSHIP - from Dr. Harry G. Brittain, whose vast experience and knowledge of the pharmaceutical industry provides readers with the authoritative advice they need and trust
COMPREHENSIVE CONTENT - that includes information appropriate for all levels of expertise in the field, from experienced pharmaceutical scientists to graduate students in physical pharmacy
200 HIGH QUALITY ILLUSTRATIONS - that present readers with a visual blueprint to the methods and techniques involved in polymorphism and solvatomorphism

The Pharmaceutical Studies Reader is an engaging survey of the field that brings together provocative, multi-disciplinary scholarship examining the interplay of medical science, clinical practice, consumerism, and the healthcare marketplace. * Draws on anthropological, historical, and sociological approaches to explore the social life of pharmaceuticals with special emphasis on their production, circulation, and consumption * Covers topics such as the role of drugs in shaping taxonomies of disease, the evolution of prescribing habits, ethical dimensions of pharmaceuticals, clinical trials, and drug research and marketing in the age of globalization * Offers a compelling, contextually-rich treatment of the topic that exposes readers to a variety of approaches, ideas, and frameworks * Provides an accessible introduction for readers with no previous background in this area

Transdermal Drug Delivery: Concepts and Application provides comprehensive background knowledge and documents the most recent advances made in the field of transdermal drug delivery. It provides comprehensive and updated information regarding most technologies and formulation strategies used for transdermal drug delivery. There has been recent growth in the number of research articles, reviews, and other types of publications in the field of transdermal drug delivery. Research in this area is active both in the academic and industry settings. Ironically, only about 40 transdermal products with distinct active pharmaceutical ingredients are in the market indicating that more needs to be done to chronicle recent advances made in this area and to elucidate the mechanisms involved. This book will be helpful to researchers in the pharmaceutical and biotechnological industries as well as academics and graduate students working in the field of transdermal drug delivery and professionals working in the field of regulatory affairs focusing on topical and transdermal drug delivery systems. Researchers in the cosmetic and cosmeceutical industries, as well as those in chemical and biological engineering, will also find this book useful.

An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Using clear language and real-world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety in topics presented offers multiple perspectives on how to integrate the Internet of Things into pharmaceutical manufacturing. This book represents a useful resource for researchers in pharmaceutical sciences, information and communication technologies, and those who specialize in healthcare and pharmacovigilance.

The use of analytical sciences in the discovery, development and manufacture of pharmaceuticals is wide-ranging. From the analysis of minute amounts of complex biological materials to the quality control of the final dosage form, the use of analytical technology covers an immense range of techniques and disciplines. This book concentrates on the analytical aspects of drug development and manufacture, focusing on the analysis of the active ingredient or drug substance. It provides those joining the industry or other areas of pharmaceutical research with a source of reference to a broad range of techniques and their applications, allowing them to choose the most appropriate analytical technique for a particular purpose. The volume is directed at analytical chemists, industrial pharmacists, organic chemists, pharmaceutical chemists and biochemists.

While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.

Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

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