The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, and with over 700 illustrations it guides pharmaceutical scientists and engineers through difficult and technical procedures in a simple easy-to-follow format. New to the third edition:

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now, it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing, and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices.This book is a must-have for pharmaceutical, biotechnology, and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget.

Written by John Lidstone and Janice MacLennan, the second edition of Marketing Planning for the Pharmaceutical Industry became accepted as the bible for the industry. In this new companion book Janice MacLennan picks up two of the themes touched on in Marketing Planning - market segmentation and branding, and the inter-relationship between these two - and with this book makes them key topics for discussion. Brand Planning for the Pharmaceutical Industry begins by exploring what branding is and why it is of importance, particularly to the pharmaceutical sector. The book then goes on to show how branding can be integrated into the early stages of the commercialization process for new products, both in theory and in the 'real' world. The book provides a step-by-step guide to brand planning, using market segmentation as the starting point. The book is split into two parts, the first dealing comprehensively with brand planning for products yet to get to the market, with the second part applying the same process to products that are already on the market. Both parts are extremely pragmatic, full of pertinent examples and insights from the pharmaceutical industry, and are directly applicable to your own brand planning. Brand Planning for the Pharmaceutical Industry concludes by confronting the problems that organizations are likely to have in actually making brand planning an integral part of their work and presents strategies for dealing with them.

Extensively revised, with an updated title that reflects its expanded scope, International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic Products, Second Edition provides the practical labeling information you need to achieve rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, the book explains the relevant laws, regulations, and requirements in major markets worldwide. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, OTC products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more. This is not a "cookbook" of easy-to-follow recipes. It is a comprehensive resource that gives you the tools to stay ahead in the ever-changing regulatory environment.

Presenting recent applications in clinical development, pharmacokinetic/ pharmacodynamic modeling, and clinical trial simulation, this in-depth reference studies the role of biomarkers in successful drug formulation and development-utilizing the latest discoveries in biomarker science to determine the safety and efficacy of emerging drug compounds.

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.

Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this three-volume reference provides detailed information on specialized products, such as emulsions, liposomes, polymers, and polymeric pharmaceutical excipients. Written by over twenty-five international experts, it explains the requirements for conducting clinical research and obtaining approval for new drug products-furnishing a current, comprehensive review of U.S. drug regulations.

Pharmaceutical Marketing in the 21st Century helps professionals in the pharmaceutical field anticipate and prepare for market changes and advances, and it guides them in adjusting their marketing strategies to remain competitive in the coming era. Ideal for product managers, planners, and strategists, this book puts the past twenty years of pharmacy into perspective and uses it as a basis for predicting the next twenty years. Internationally relevant, this book is now available in Japanese!Distinguished contributors provide a formal conjecture on the nature of various aspects of pharmaceutical marketing in the early part of the 21st century. Utilizing their experience and expertise, they provide pharmaceutical professionals with guidelines for marketing in the coming years. Readers gain insight into what the future may hold in these areas: pricing, product development, distribution, promotion, retailing, market research, and other areas. Experts who make professional speculations in Pharmaceutical Marketing in the 21st Century include these among others: William R. Mattson, Jr. (President, The Mattson Jack Group, St. Louis) and Evan G. Dick (Vice President and General Manager, MedStrategy Management Reports, St. Louis). They compare pharmaceutical marketing of 20 years ago with that of today and use the comparison as a basis for making projections 20 years into the future. David W. Newton (Albany College of Pharmacy). He predicts an increased importance and possible necessity of the pharmacist's role in direct/indirect patient care services. Jerome A. Reinstein (industry consultant and Director-General, World Federation of Proprietary Medicine Manufacturers, London). He explores the increasing number of prescription drugs becoming available over the counter. Pharmaceutical marketers and benefits managers, regulatory officials, drug product managers, advertising agency executives, and politicians will find Pharmaceutical Marketing in the 21st Century a must read as they work today in preparation for the future of pharmaceutical care and marketing.

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.

This book discusses the influence of the pharmaceutical industry on the practice of medicine, and the observed and potential pitfalls of such partnerships. It argues that the pharmaceutical industry has become indispensable to many of the activities of the medical profession across the pharmaceutical product lifecycle, and examines the regulatory, ethical, professional and institutional difficulties that arise from these interactions. With data drawn from over 80 qualitative accounts from medical, pharmaceutical, regulatory and healthcare professionals, this book uses both Hungary and the Netherlands as case studies to demonstrate the potential problem of undue pharmaceutical industry influence within the relationships fostered with the profession of medicine. Chapters systematically describe the lifecycle of a pharmaceutical product from research to distribution, demonstrating the interdependency of industry and medicine. Arguing that the medical profession should be a buffer between the pharmaceutical industry interests and patient interests, the book explores how undue industry influence weakens the ability of the medical profession to do so. Using the theory of institutional corruption, the book aims to analyze how conflict of interest and the weakening of institutional imperatives is a result of institutional interactions rather than individual actions. Appropriate for students and researchers of the pharmaceutical industry, corporate corruption, and those working in NGOs and policy making, this unique volume is an comprehensive look at the complex relationship between medicine and pharmacy.

Advances and Challenges in Pharmaceutical Technology: Materials, Process Development and Drug Delivery Strategies examines recent advancements in pharmaceutical technology. The book discusses common formulation strategies, including the use of tools for statistical formulation optimization, Quality by design (QbD), process analytical technology, and the uses of various pharmaceutical biomaterials, including natural polymers, synthetic polymers, modified natural polymers, bioceramics, and other bioinorganics. In addition, the book covers rapid advancements in the field by providing a thorough understanding of pharmaceutical processes, formulation developments, explorations, and exploitation of various pharmaceutical biomaterials to formulate pharmaceutical dosage forms.

In Longshot, investigative journalist David Heath takes readers inside the small group of scientists whose groundbreaking work was once largely dismissed but whose feat will now eclipse the importance of Jonas Salk's polio vaccine in medical history. With never-before-reported details, Heath reveals how these scientists overcame countless obstacles to give the world an unprecedented head start when we needed a COVID-19 vaccine. The story really begins in the 1990s, with a series of discoveries that were timed perfectly to prepare us for the worst pandemic since 1918. Readers will meet Katalin Kariko, who made it possible to use messenger RNA in vaccines but struggled for years just to hang on to her job. There's also Derrick Rossi, who leveraged Kariko's work to found Moderna but was eventually expelled from his company. And then there's Barney Graham at the National Institutes of Health, who had a career-long obsession with solving the riddle of why two toddlers died in a vaccine trial in 1966, a tragedy that ultimately led to a critical breakthrough in vaccine science. With both foresight and luck, Graham and these other crucial scientists set the course for a coronavirus vaccine years before COVID-19 emerged in Wuhan, China. The author draws on hundreds of hours of interviews with key players to tell the definitive story about how the race to create the vaccine sparked a revolution in medical science.

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.

This authoritative reference covers recent advances in the field, stressing an interdisciplinaryapproach to the development and use of biosensor technology in physics,engineering, analytical chemistry, and biochemistry (including immunochemistry).about the editors ...RICHARD P. BucK is a Professor in the Chemistry Department, University of Northcarolina, Chapel Hill. Professor Buck serves on the editorial boards of severaljournals including Analytical Instrumentation: Applications and Designs for Chemica~Biomedica~ and Environmental Science (Marcel Dekker, Inc.). He is a member of theAmerican Chemical Society, Electrochemical Society, and International Society ofElectrochemistry. He received the B.S. (1950) and M.S. (1951) degrees from thecalifornia Institute of Tochnology, Pasadena, and Ph.D. degree (1954) from theMassachusetts Institute of Tochnology, cambridge.W1WAM E. HATFIELD is Mary Ann Smith Professor and Vice Chairman of Chemistry,and Acting Chairman of the Curriculum in Applied Sciences, University of Northcarolina, Chapel Hill. He is the author or coauthor of over 300 publications, andcoeditor, with John H. Miller, Jr., of High-Temperature Superconducting Materials:Preparations, Properties, and Processing (Marcel Dekker, Inc.). He is a member of theAmerican Chemical Society, American Association for the Advancement of Science,and Materials Research Society. He received the B.S. (1958) and M.S. (1959) degreesfrom Marshall University, Huntington, West Virginia, Ph.D. degree (1962) from theUniversity of Arizona, Tucson, and completed postdoctoral research at the Universityof Illinois, Urbana.M1KTHA UMANA is an independent consultant to Glaxo Inc. and Research 'IriangleInstitute, Research 'Iriangle Park, and Duke University Engineering Research Center,Durham, North carolina. The coauthor of numerous scientific journal articles, herresearch interests include surface chemistry, electrochemistry, and biosensors. Shereceived the B.Sc. degree (1969) from the University of Chile, Santiago, and Ph.D.degree (1972) from the University of London, England.EDMOND E BowoEN is an Associate Professor in the Department of Chemistry andin the Biotechnology Program, North carolina State University, Raleigh. Thecoauthor of numerous journal articles, his research interests include bioelectrochemistry,biological electron transfer, biosensors, and surface chemistry. He receivedthe B.S. degree (1970) from Syracuse University, Syracuse, New York, and Ph.D.degree (1982) from Virginia Commonwealth University, Richmond.

The pharmaceutical industry worldwide is a rapidly burgeoning industry contributing to growth of gross domestic product and employment. Technological change in this field has been very rapid, with many new products being introduced. For this reason in part, health care budgets throughout the world have increased dramatically, eliciting growing pressures for cost containment. This book explores four important issues in pharmaceutical innovations: (1) the industry structure of pharmaceutical innovation; (2) incentives for correcting market failures in allocating resources for research and development; (3) competition and marketing; and (4) public evaluation of the benefits and costs of innovation. The lessons are applicable to countries all over the world, at all levels of economic development. By discussing existing evidence this book proposes incentive arrangements to accomplish social objectives.

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.

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.

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.

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 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. ​        

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