This book examines the impact of economic reforms in India on the pharmaceutical industry and access to medicines. It traces the changing production and trade pattern of the industry, research and development (R&D) preferences and strategies of Indian pharmaceutical firms, patent system alongside pricing policy measures and their shortcomings. It also analyses the public health financing system in India driven largely by out-of-pocket expenditure - about 60 per cent - and characterised by very high share of medicines in total health expenditure. A masterful insight into a topical area, the work will be indispensable to those working on pharmaceutical industry and public policy. It will be of interest to researchers, scholars, students, and policy-makers of economics, industrial policy, public policy, intellectual property rights and health financing.

The global pharmaceutical industry is currently estimated to be worth $1 trillion. Contributors chart the rise of scientific marketing within the industry from 1920-1980. This is the first comprehensive study into pharmaceutical marketing, demonstrating that many new techniques were actually developed in Europe before being exported to America.

First published in 1979, Supplies Management for Health Services looks at the characteristics and problems of hospital suppliers and examines the way in which the hospital and the National Health Service deal with supplies problems and relations with suppliers. Beginning with a description of the National Health Service and its supplies' organisations and the role of the Department of Health and Social Security in this field, the book then reports on the detailed studies made over two years of the supplies' problems of ten London area health authorities and ten London manufacturers of medical equipment. The NHS situation is then contrasted with the supplies' situation in three non-health organisations and with the health supplies situation in France and West Germany. The final part of the book analyses the information obtained, proposes a means of assessing supplies systems, and evaluates the NHS situation. This is followed by the realistic proposals for reform, advocating a system similar to that used in British defence services, based on a central procurement agency, close cooperation with private manufacturers, and manufacture by government where necessary. This book will surely interest students of economics and global health.

Many countries and regions are actively promoting high technology industries as a means of stimulating the economy. The authors point out that these efforts are not only encouraging economic development, but they also reduce an economy's vulnerability to the negative consequences of world trade. By weaving together the fields of health economics, industrial organisation and industrial development, this book describes the benefits of promoting a country's health industry as a way of stimulating its high-technology industrial capacity. The authors illustrate that the development of a country's health industry not only improves the country's health status, but also promotes an industry with relatively stable, high-wage employment, creates the potential for exporting goods and services, and produces scientific spillovers that will favourably impact other high-technology industries. Health Policy and High-Tech Industrial Development will be of great interest to health policy analysts by showing that health policies have broader implications than merely affecting health systems. Health economists should consider the advantages of viewing a country's health system not only as a unique industry that produces both health care and high-technology goods and services, but that also possesses the ability to stimulate development of a broader array of high-technology industries. Development and industrial economists and policymakers will also see the health sector from this different and innovative perspective.

This book examines the nature and extent of competition in the pharmaceutical industry and analyses the interaction between market structure and selected elements of the marketing mix. It provides valuable insights into the level of promotional expenditure required to achieve a significant market share for new products; the use of price, new products and promotional strategies to protect market share; the effects of patent expiration on price levels and the use of pricing strategy to achieve market share. The book includes a brief comparative analysis of competition and marketing strategies in the US ethical pharmaceutical market.

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.

Encapsulation of bioactives is a fast-growing approach in the food and pharmaceutical industry. Spray Drying Encapsulation of Bioactive Materials serves as a source of information to offer specialized and in-depth knowledge on the most well-known and used encapsulation technology (i.e., spray drying) and corresponding advances. It describes the efficacy of spray drying in terms of its advantages and challenges for encapsulation of bioactive ingredients. Discusses the potential of this technique to pave the way toward cost-effective, industrially relevant, reproducible, and scalable processes that are critical to the development of delivery systems for bioactive incorporation into innovative functional food products and pharmaceuticals Presents the latest research outcomes related to spray drying technology and the encapsulation of various bioactive materials Covers advances in spray drying technology that may result in a more efficient encapsulation of bioactive ingredients Includes computational fluid dynamics, advanced drying processes, as well as the morphology of the dried particles, drying kinetics analyzers, process controllers and adaptive feedback systems, inline powder analysis technologies, and cleaning-in-place equipment Aimed at food manufacturers, pharmacists, and chemical engineers, this work is of interest to anyone engaged in encapsulation of bioactive ingredients for both nutraceutical and pharmaceutical applications.

Pharmaceuticals play a central role in health care throughout the world. The pharmaceutical industry is beset with difficulties as increasing research and development expenditure yields fewer new treatments. Public and private budgets strain under the weight of high prices and limited access. The world's poor see little effort to address diseases prevalent in less affluent societies, while the world's wealthy are overusing prescription drugs, risking their health and wasting resources. The debate over health care reform and the ongoing global economic crisis form the backdrop for this extraordinarily timely examination of the global system for the development, production, distribution and use of medicines. The authors are acknowledged experts in the fields of pharmaceutical law and policy, with many years experience advising governments, multilateral organizations and policy-makers on issues involving innovation, access and use of medicines. Supported by a team of independent scientists, doctors and lawyers, they take an insightful look at the issues surrounding global regulation of the pharmaceutical sector, and offer pragmatic suggestions for reform. This book will be of interest to government policy-makers, members of industry, healthcare professionals, teachers, students and lawyers in the fields of public health, intellectual property and international trade.

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

A comprehensive exploration of the massive changes in the biopharmaceutical supply chain that have occurred during the past 10 years, and predicted future trends, Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead documents the specific impacts of these changes for key players in the supply chain.

Based on interviews with industry professionals, the book presents an overview of the key challenges and discusses how leading biopharmaceutical companies handle these challenges. It exposes the underlying structures that support the biopharmaceutical supply chain, focusing specifically on distribution-the point at which manufacturers release a finished product to the time that it is administered, and the complicated set of channels that exist between these two points. This overarching view of the supply chain provides an important piece of intelligence that can inform business strategy for life sciences manufacturers and distributors and help them achieve success in this industry.

Freeze-drying, in the past popular in the food industry, has more recently been adopted by the pharmaceutical industry as a standard method for the production of stable solid preparations. Freeze-drying of Pharmaceuticals and Biopharmaceuticals is the first book to specifically describe this process, as related to the pharmaceutical industry. The emphasis of this book is on the properties of the materials processed, how effective formulations are arrived at, and how they are stored and marketed. Beginning with a historical overview of the process, Freeze-drying of Pharmaceuticals and Biopharmaceuticals briefly describes the processes and equipment involved, including: the physics, chemistry and biochemistry associated with freezing, aspects of formulation development, primary and secondary drying; the economics and engineering of scaling up; and, most importantly, attributes of the dried product. It also discusses in detail the science behind freeze-drying, such as the properties of crystalline and amorphous solids. The book concludes with selected case studies and discusses the future of freeze-drying, advances in alternative drying methods, and concludes with an extensive bibliography. This book, written by a leading expert in the field, is aimed primarily at product and process developers in the biopharmaceutical industry and academia.

Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.

Neoliberals often point to improvements in public health and nutrition as examples of globalisation's success, but this book argues that the corporate food and medicine industries are destroying environments and ruining living conditions across the world. Scientist Stan Cox expertly draws out the strong link between Western big business and environmental destruction. This is a shocking account of the huge damage that drug manufacturers and large food corporations are inflicting on the health of people and crops worldwide. Companies discussed include Wal-Mart, GlaxoSmithKline, Tyson Foods and Monsanto. On issues ranging from the poisoning of water supplies in South Asia to natural gas depletion and how it threatens global food supplies, Cox shows how the demand for profits is always put above the public interest. While individual efforts to 'shop for a better world' and conserve energy are laudable, Cox explains that they need to be accompanied by an economic system that is grounded in ecological sustainability if we are to find a cure for our Sick Planet.

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Freeze drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulations that impact lyophilization practices. This new edition of Freeze Drying/ Lyophilization of Pharmaceutical and Biological Products addresses these changes with updated and new chapters on emerging developments in lyophilization technology, research, and industry procedures. Providing both a scientific and industrial perspective, this comprehensive text is a valuable resource for all those who use freeze drying technology.

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

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

This "Second Edition" brings you up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
REVISION OF A BESTSELLER - provides updates on the quality control regulations for APIs that have been added or amended since the first edition to ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries
NEW CHAPTERS - on safety, efficacy, and environmental/regulatory requirements keeps readers up-to-date with the latest in the field
EXPERT ANALYSIS - of the recent movement of API manufacturing from the US and Europe to countries such as India and China keeps pharmaceutical professionals and drug manufacturers aware of current and potential changes in regulations
DETAILED DISCCUSIONS - of both US and international regulatory requirements and the FDA's intensified foreign inspection program enables readers to adequately prepare for and pass inspections

"Practical Utility of Biomarkers in Drug Discovery and Development" covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.

"Pharmaceutical Process Engineering, Second Edition" is the ideal introductory text for pharmaceutical scientists and technologists.
With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry.
Key features:
REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmaceutical scientists and technologists up-to-date
IDEAL INTRODUCTORY TEXT - Covers basic engineering principles, drug production, and development processes, so scientists can easily convert bulk pharmaceutical products into patient-ready dosage forms
NEW INFORMATION - on quality principles that include quality by design; mathematical and statistical approaches to experimental design; computer aided design; and PAT (process analytical technology) keeps professionals at the forefront of their field
COMPREHENSIVE COVERAGE - Step-by-step methods of drug production, knowledge of major unit operations, and key concepts of pharmaceutical engineering will help to improve communication among the varied professionals working in the pharmaceutical industry

This new volume, Herbal Product Development: Formulation and Applications, addresses some of the challenges that hinder the path of successful natural products from laboratory to market. Highly skilled, experienced, and renowned scientists and researchers from around the globe offer up-to-date information that describes characteristics of herbs and herbal products, applications, evaluation techniques, and more. There is also a section dedicated to alternative medicinal strategies for the treatment and cure of diverse diseases. Also considered, of course, is the efficacy and safety of herbal products, which are of major concern. This valuable volume will be an important addition to the library of those involved in herbal product development and testing, including researchers, scientists, academicians, industry professionals, and students in this area.

The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields

This timely Second Edition reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, and the shift from developing small molecules to the growth of biopharmaceuticals. It meets the need for up-to-date and advanced information for drug preformulation and formulation, and addresses the current trends in the continually evolving pharmaceutical industry.

Ideal for practitioners working in the pharmaceutical industry (including R&D scientists, technicians, and managers), as well as undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology, this text addresses:

• candidate drug selection
• drug discovery and development
• preformulation predictions and drug
• selections
• product design to commercial dosage form
• biopharmaceutical support in formulation
• development
• and more

The first book to details the history and social implications of the little blue pill Since its introduction in 1998, Viagra has launched a new kind of sexual revolution. Quickly becoming one of the most sought after drugs in history, the little blue pill created a sea change within the pharmaceutical industry-from how drugs could be marketed to the types of drugs put into development-as well as the culture at large. Impotency is no longer an embarrassing male secret; now it is called "erectile dysfunction," and is simply something to "ask your doctor" about. And over 16 million men have. The Rise of Viagra is the first book to detail the history and the vast social implications of the Viagra phenomenon. Meika Loe argues that Viagra has changed what qualifies as normal sex in America. In the quick-fix, pill-for-everything culture that Viagra helped to create, erections can now be had by popping a pill, making sex on demand, regardless of age or infirmity, and, potentially, for the rest of one's life. Drawing on interviews with men who take the drug, their wives, doctors and pharmacists as well as scientists and researchers in the field, this fascinating account provides an intimate history of the drug's effect on America. Loe also examines the quest for the female Viagra, the impact of the drug around the world, the introduction of new erection drugs, like Levitra and Cialis, and the rapid growth of the multi-billion dollar pharmaceutical industry. This wide-ranging book explains how this medical breakthrough and cultural phenomenon have forever changed the meaning of sex in America.

From a managerial perspective, the biopharmaceutical industry represents a competitive, fast-changing, intellectually-powered, innovation-driven sector. Many management scholars have studied this discontinuous era to make sense of strategic behavior and the cognition of firms and top managers. A past look at the biopharmaceutical industry provides answers to questions that most managers have. For example, what options do you have and what actions do you take when new firms enter your industry? In the 1970s, new biotechnology firms, funded by venture capitalists, appeared in the pharmaceutical industry with new knowledge. Successful pharmaceutical firms decided to collaborate with the new entrants and forge relationships to develop and create new, biotechnology engineered drugs. Thus, the addition of new biotechnology firms ushered in a new business model based on strategic alliances. Strategic alliances have now become an industrial norm called open innovation. The author looks at the historical path of the biopharmaceutical industry, particularly in the United States. While the pharmaceutical industry's main contributions to society are substantial, there are pressing challenges the industry must face, such as an increase in infectious disease outbreaks or the global aging population, which require new types of care, additionally, mental health care and prescription painkiller addiction are persistent issues with economic repercussions to both federal and local governments. This book presents a holistic view of the biopharmaceutical industry, putting it in a historical context. It will best serve those who are eager to learn about this dynamic, fast-evolving industry and who would like to tackle current biopharmaceutical industry issues in the United States and be prepared for future industry challenges.