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.

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.

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.

Global Issues in Pharmaceutical Marketing presents a balanced, research-based perspective combined with a practical outlook on the current issues faced by the ethical, biotech, and generic segments of the pharmaceutical industry. It integrates an analytical approach with a global view to examine such issues as market access, digital marketing, emerging markets, branding, and more. The book covers not only the North American and Western European markets, but focuses on non-Western markets, such as Latin America and Asia. Each chapter is written as an individual essay about a given issue, and where relevant, original cases are provided to illustrate how these issues are currently managed by the global industry. This book offers a thoughtful and thorough description of the industry's current situation and integrates the latest scholarly and industry research from different disciplines in one place for convenient reference. It may be used in the following ways: To stimulate class discussions and inspire new streams of research for academics and graduate students; To introduce the industry to those interested in a career, to orient new industry hires, or to provide experienced practitioners with current research that will enhance their knowledge; To provide an understanding of the industry for those in the healthcare sector, such as physicians, pharmacists, as well as medical and pharmacy students; and To present recent and relevant research for those in government, public or private payers, and public policy environments to facilitate their decision making. This book will prove to be a useful resource and an important source of information for academics and their students, professionals, and policymakers around the world.

Global Issues in Pharmaceutical Marketing presents a balanced, research-based perspective combined with a practical outlook on the current issues faced by the ethical, biotech, and generic segments of the pharmaceutical industry. It integrates an analytical approach with a global view to examine such issues as market access, digital marketing, emerging markets, branding, and more. The book covers not only the North American and Western European markets, but focuses on non-Western markets, such as Latin America and Asia. Each chapter is written as an individual essay about a given issue, and where relevant, original cases are provided to illustrate how these issues are currently managed by the global industry. This book offers a thoughtful and thorough description of the industry's current situation and integrates the latest scholarly and industry research from different disciplines in one place for convenient reference. It may be used in the following ways: To stimulate class discussions and inspire new streams of research for academics and graduate students; To introduce the industry to those interested in a career, to orient new industry hires, or to provide experienced practitioners with current research that will enhance their knowledge; To provide an understanding of the industry for those in the healthcare sector, such as physicians, pharmacists, as well as medical and pharmacy students; and To present recent and relevant research for those in government, public or private payers, and public policy environments to facilitate their decision making. This book will prove to be a useful resource and an important source of information for academics and their students, professionals, and policymakers around the world.

Research and Development is the vehicle by which organizations and economies create opportunity, innovation and secure a stream of future products and services.These outcomes are all critically important sources of sustainability in a world that is changing faster than most companies can keep up.The challenge behind them is the fundamental unpredictability of R which is why effective project management is so important. Ron Basu's Managing Projects in Research and Development explains how and why project management can provide a means of helping to plan, organise and control multi-disciplinary research activities without stifling innovation. Combining research with practical examples and experience from a career that has included blue chip organizations such as GSK, GlaxoWellcome and Unilever, Ron Basu offers a rigorous guide to the fundamentals of R&D project management including project lifecycle management, risk management, cost, time quality and other success measures as well as the keys to operational excellence in this complicated world.

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.

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.

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.

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.

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

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.

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.

The fields of pharmaceutical economics and health economics/policy are reaching a point of convergence. This is due to both the widespread availability of pharmaceutical treatments, accompanied by broader insurance coverage, and the regulation of prescription drugs in both private and government plans. This book will bridge the gap. We will explore developments in both U.S. and International setting. The system of the U.S. is characterized by a mix of private and government insurance for prescription drugs with the expansion of Medicare Part D. Most other developed countries are characterized by social insurance with either the government as a single payer such as in Canada or Australia, or a national health service as in many other European countries.

Originally published in 1999 The Commercial Use of Biodiversity examines how biodiversity and the genetic material it contains are now as valuable resources. Access to genetic resources and their commercial development involve a wide range of parties such as conservation and research institutes, local communities, government agencies and companies. Equitable partnerships are not only crucial to conservation and economic development but are also in the interests of business and often required by law. In this authoritative and comprehensive volume, the authors explain the provisions of the Convention on Biological Diversity on access and benefit-sharing, the effect of national laws to implement these, and aspects of typical contracts for the transfer of materials. They provide a unique sector-by-sector analysis of how genetic resources are used, the scientific, technological and regulatory trends and the different markets in Pharmaceuticals, Botanical Medicines, Crop Development, Horticulture, Crop Protection, Biotechnology (in fields other than healthcare and agriculture) and Personal Care and Cosmetics Products. This will be an essential sourcebook for all those in the commercial chain, from raw material collection to product discovery, development and marketing, for governments and policy-makers drafting laws on access and for all the institutions, communities and individuals involved in the conservation, use, study and commercialisation of genetic resources.

Providing methodologies that can serve as a reference point for new formulations, the second volume covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution, and other similar products. Highlights from Uncompressed Solid Products, Volume Two include: the fundamental issues of good manufacturing practices formulations for more than 400 pharmaceutical products, including currently approved products and innovative products such as small proteins, instantly liquifiable powders, and nanoparticles access to US FDA guidelines, as well as all major guidelines around the world identification and inclusion of the most often approved capsules and powders in the US

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.

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.

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.

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.

This title was first published in 2003. Presenting information is a vital part of the job of both the medical director and other senior executives in the pharmaceutical industry, and yet the majority receive no training for this. Presentations have to be made internally to colleagues, clinical staff, marketing and product managers and medical sales representatives; and externally to professional medical specialists and NHS staff, the media and the general public. Anyone who manages or communicates adverse news needs to do so quickly and effectively, and be prepared to face difficult questions under media scrutiny. In this book, John Lidstone, an author acknowledged by the industry as an expert in marketing and presentation skills, provides readers with the tools and skills to make their presentations and media dealings a success. The book is divided into two parts. Part One, Preparing and Delivering Formal Presentations, provides extensive practical guidance on the techniques of effective presenting: establishing objectives and preparing the presentation, delivering the opening, core and conclusion, using visual aids and dealing with questions. It also includes a chapter on the skills required for video conferencing. The second part, Handling the Media, contains invaluable insight and instruction for a pharmaceutical executive facing any element of the media. It draws on the author's extraordinary experience and provides examples and advice with direct relevance to the pharmaceutical industry throughout, making this the only specialist book available on the subject.

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

"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