Medicine Price Surveys, Analyses and Comparisons establishes guidelines for the study and implementation of pharmaceutical price surveys, analyses, and comparisons. Its contributors evaluate price survey literature, discuss the accessibility and reliability of data sources, and provide a checklist and training kit on conducting price surveys, analyses, and comparisons. Their investigations survey price studies while accounting for the effects of methodologies and explaining regional differences in medicine prices. They also consider policy objectives such as affordable access to medicines and cost-containment as well as options for improving the effectiveness of policies.

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors - states, transnational business corporations, or civil society groups - and their influence on the structures - such as national and international agreements, organizations, and private entities - that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

Polymeric Nanosystems: Theranostic Nanosystems, Volume One examines the applications of nanotherapeutic systems and nanodiagnostics in relation to polymeric nanosystems. In the last decade, numerous biopolymers have been utilized to prepare polymeric nanosystems for therapeutic applications. These biopolymers include polylactic acid, polylactide-co-glycolide, polycaprolactone, acrylic polymers, cellulose and cellulose derivatives, alginates, chitosan, gellan gum, gelatin, albumin, chontroitin sulfate, hyaluronic acid, guar gum, gum Arabic, gum tragacanth, xanthan gum, and starches. Besides these biopolymers, grafted polymers are also being used as advanced polymeric materials to prepare many theranostic nanocarriers and nanoformulations. This book explores the array of polymeric nanosystems to understand therapeutic potentials. It will be useful to pharmaceutical scientists, including industrial pharmacists and analytical scientists, health care professionals, and regulatory scientists actively involved in the pharmaceutical product and process development of tailor-made polysaccharides in drug delivery applications.

Inorganic Nanosystems: Theranostic Nanosystems, Volume Two examines the applications of nanotherapeutic systems and nanodiagnostics in relation to polymeric nanosystems. In the last decade, numerous biopolymers have been utilized to prepare polymeric nanosystems for therapeutic applications. These biopolymers include polylactic acid, polylactide-co-glycolide, polycaprolactone, acrylic polymers, cellulose and cellulose derivatives, alginates, chitosan, gellan gum, gelatin, albumin, chontroitin sulfate, hyaluronic acid, guar gum, gum Arabic, gum tragacanth, xanthan gum, and starches. Besides these biopolymers, grafted polymers are also being used as advanced polymeric materials to prepare many theranostic nanocarriers and nanoformulations. This book explores the array of polymeric nanosystems to understand therapeutic potentials. It will be useful to pharmaceutical scientists, including industrial pharmacists and analytical scientists, health care professionals, and regulatory scientists actively involved in the pharmaceutical product and process development of tailor-made polysaccharides in drug delivery applications.

Nanotechnology for Drug Delivery and Pharmaceutical Sciences presents various drug-delivery techniques that utilize nanotechnology for the biomedical domain, highlighting both therapeutic and diagnostic applications. The book provides important facts and detailed studies on different promising nanocarriers like liposomes, exosomes and virus-based nanocarriers. Moreover, it explores these nanocarriers' utilization in the therapeutic applications of various diseases such as cancer, inflammation, neurodegenerative disorders like Huntington's disease, Alzheimer's disease, human immunodeficiency virus (HIV), and inflammatory bowel disease. In addition, the book describes how nanotechnology has efficiently overtaken conventional dosage forms and provided comfort and ease to patients. Relevant information regarding market trends, patents and social-economic factors are also provided, making this the perfect reference for doctors, researchers and scientists working in the fields of medicine, biochemistry, biotechnology, nanobiotechnology and the pharmaceutical sciences.

Trail-blazing social entrepreneurs are tackling the world's most pressing problems that government, business, or charity have failed to solve. They are creating businesses with a primary mission of social change. Scott Boyer is one such social entrepreneur. This 28-year veteran of Big Pharma left a six-figure salary to start OWP Pharmaceuticals and the ROW Foundation. This commercial business and non-profit organization exist in a symbiotic relationship we call a "tandem hybrid social enterprise." This model combines a multimillion dollar business with a foundation that's on track to become the largest funder of projects serving people with epilepsy and associated psychiatric disorders in the world. The tandem hybrid incorporates the principles learned by Scott and others for building a truly unique social enterprise from the ground up; one that is: Driven by a compelling social mission Financed by commercial success Structured to retain control Scalable and sustainable for the long haul Powering Social Enterprises With Profit And Purpose offers a detailed blueprint that has proven commercially and philanthropically successful and that can be replicated in most business sectors.

This invaluable volume serves as a guide to up-to-the-minute techniques for the discovery and evaluation of pharmacologically active compounds for therapeutic development. Focusing on practical applications, provided by expert practitioners from both industry and academic research laboratories, Advances in Drug Discovery Techniques covers rational drug design, high-throughput screening and genetic approaches to drug discovery. Moreover, chapters also focus on advances in the use of combinatorial chemistry and natural products, both of which support the chemical diversity for many drug screening programmes. Typical screening studies and their link to robotics and informatics are also presented in detail, together with an overview of current progress within antisense therapeutics. Overall, this book will be an excellent reference source for all individuals interested in making sense of the rapid changes in drug discovery that result from developments in molecular biology, robotics and informatics.

This book presents the findings of systematic research into the healthcare medicine management policies of China. In-depth comprehensive research has been carried out, targeting multiple issues of particular importance in healthcare medicine management, such as the purchasing, pricing, payment, usage, and the function of commercial healthcare insurance in medical payment. The book goes on to put forward policy advice regarding the aforementioned issues.

Provides a comprehensive review of challenges and opportunities as related to the applications of big data, AI, and machine learning in the entire spectrum of drug R&D Discusses regulatory developments in leveraging big data and advanced analytics in drug review and approval Offers a balanced approach to data science organization build Presents real-world examples of AI-powered solutions to a host of issues in the lifecycle of drug development Affords sufficient context for each problem and provides detailed description of solutions suitable for practitioners with limited data science expertise

For most Western audiences, Cuba is a touristic paradise stuck in time and virtually detached from world technology networks by the US embargo - anything but a hub of industrial innovation and high value-added biotechnology. However, a closer look reveals more subtle but equally powerful stories that challenge the homogenizing assumptions of conventional economics and open up scope for more sophisticated reflections on Cuban economy and industry. From this kind of enquiry emerges the case of the internationally respected Cuban biotech industry as the most successful case of science and technology policy in the country's economic history. The book takes an interdisciplinary approach, exploring issues such as interdependency, purpose and history as natural constituencies of the innovation process. It also examines the dynamic and crucial role played by the state in the formation of innovative business enterprises. This book will be of interest to academic researchers in the fields of innovation and economic development.

This volume fills an important need for understanding about the interplay between China's intellectual property protection system and the potential for innovation in China's economy. Using examples from the pharmaceutical and biotech industries, the author suggests that, despite the widely documented challenges facing China's IPR protection system, the system has a demonstrable effect on innovation. The author suggests that China's patent system promotes innovation through economic incentives, soft factors of public encouragement, and intentional development strategies. This book is also useful as an overview of China's biotech and pharmaceutical sectors, offering a range of richly detailed case studies on China's industrial development strategies in these sectors. A number of important patent disputes between Chinese and foreign companies are also examined to useful effect. In the highly contentious policy world of intellectual property protection and pharmaceutical and biotech industry development, the volume offers a refreshing combination of detail and insight.'uPitman B. Potter, University of British Columbia, Canada'Yahong Li's pioneering study, Imitation to Innovation in China, breaks new ground in closely examining the extent to which the Chinese government's patent policies and patent activity by Chinese firms are influencing China's coming transformation from an imitation-oriented country to an innovation-oriented one. Her combination of theoretical and empirical approaches exploring the links between public policy, patenting activity and technological innovation (commercialization) is an important contribution to development studies, not just for China but for other newly innovative countries as well.'uWilliam O. Hennessey, Franklin Pierce Law Center, USA Following decades in which China's approach to technology has been to imitate, the country is now transforming itself to become innovation-oriented. This pioneering study examines whether patents play as similar a role in promoting innovation in China as they do in the West, exploring the interplay between patents and China's biotechnology and pharmaceutical industries in particular. The author argues for a stronger patent regime based on an extensive review of the technological capacity, R&D models, patent filings and litigations, and issues in patent law, which involve China's biotechnology and pharmaceutical industries. By comparing China with other developing countries and analyzing China's uniqueness in terms of its development stage, technological capacity and the strengths and weaknesses in its patent system, the author concludes that China is distinguished from the prevailing view that patents play a limited role in innovation in developing countries. The book also discusses whether and how patents can promote innovation in China's biotechnology and pharmaceutical industries, based on the study of market scale, R&D capacity, innovation model and patent legislation and cases.

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Oral Delivery of Therapeutic Peptides and Proteins provides a complete overview of the journey scientists pursue to attain protein and peptide oral delivery. The book highlights the physiological challenges that must be accounted for in addition to overcoming protease inhibition and acid stability issues that are commonly mentioned in this area of research. Primary topics include formulation technologies being adopted for oral delivery of proteins and peptides, modification of actives to make them more suited for oral delivery, animal models and their shortcomings in assessing oral bioavailability, and in vitro models to simulate drug absorption and transport. Academics and industry researchers working in formulation development and researchers and advanced students in biotechnology and pharmacy will find this a useful resource.

Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers' needs, the drug will fail to reach its intended market value. Introduction to Market Access for Pharmaceuticals is based on an accredited course in this area, taken from the European Market Access University Diploma (EMAUD), and is affiliated with Aix Marseille University. Key Features: The first guide to market access for pharmaceuticals based on tested teaching materials Addresses both pharmaceutical and vaccine products Includes case studies and scenarios Covers market access consdierations for Western Europe, the USA, Japan and China Explains the impact the changing healthcare market will have on your product

Key Account Management Excellence in Pharma & Medtech is designed to help life sciences practitioners develop and execute innovative and effective key account management (KAM) strategies and capabilities. Pharmaceutical and medtech companies are increasingly pursuing KAM in response to the rapid rise of large, sophisticated and complex healthcare provider and payer systems and groups. Those that invest the time to get KAM right will protect their business and grow with these rising customers. This book is groundbreaking in both its scope and its tailoring of leading KAM practices specifically for life sciences. The central theme is that "key account management is an organization-wide business strategy, not just a role or a sales-specific initiative." KAM is a strategy focused on providing unique offerings and value through an orchestrated, cross-functional, go-to-market model designed specifically to address the needs and engagement preferences of a unique segment of customers. The insights and practices shared in this book are designed to be a valuable reference at every stage of the KAM journey. The book has been designed to facilitate a common language and deep understanding of KAM issues and leading practices organization-wide-particularly for life sciences leaders, account managers and cross-functional team members responsible for building, transforming and supporting their organization's KAM strategies and capabilities.

This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.

Economic Evaluation of Pharmacy Services provides the latest on the trend to a more product-centered and service-centered practice, eschewing traditional economic evaluation techniques that focus on product-to-product comparisons in favor of evaluating processes that measure costs and health outcomes. Complete with examples focusing on best practices, including various study designs, types of pharmacy services, and types of outcomes being evaluated, the book emphasizes case studies and examples that help readers understand economic evaluation techniques. Many of these techniques are transferable across countries, especially where there are advanced and stable health systems in place. With the help of this practical guide, readers will gain a thorough understanding of the application of economic evaluation of pharmacy services.

Endothelium, the new volume in the Advances in Pharmacology series, presents readers with a variety of chapters that cover various endothelium-derived mediators and their changes with gender, and during vascular development, senescence, and hypertensive disorders. Topics include endothelium, nitric oxide, gap junctions, potassium channels, endothelin, vascular development, vascular permeability, gender, aging, and preeclampsia. With contributions from the best authors in the field, the volume is an essential resource for pharmacologists, immunologists, and biochemists alike.

The pharmaceutical industry, long thought of as a recession-proof investment, now faces a day of reckoning. The reasons for this impending downfall are not hard to discern. The prices the industry charges for its prescription drugs have escalated at four to five times the cost-of-living increases during the past two decades and have reached a point where 30% of Americans must choose between filling a prescription, paying for housing, and buying food. This has brought about public pressure on governments around the world to control drug prices, yet the world's twenty largest pharma companies realized 80% of their growth as a result of exorbitant price hikes. Pharma currently enjoys its extraordinary profitability by exploiting the world's most vulnerable populations. Yet even their ability to increase prices in the face of falling demand does not satisfy their profit demands. The breadth and depth of pharma's marketing transgressions exceed those of any other industry and have now reached a point where authorities around the world have found it necessary to take legal action against its violations. Drastic change is needed if the pharmaceutical industry can equitably advance the health of the world's population and regain public esteem. This book illustrates the range and extent of pharma's violations and addresses the actions that should be implemented in order to make the drug industry a more constructive, less venal part of contemporary society. It will be of interest to researchers, academics, practitioners, and students with an interest in the pharmaceutical industry, healthcare management, regulation, and bioethics.

The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship.

Offers a new perspective on "traditional" Asian medicines Provides original insights into "traditional" Asian pharmaceutical industries Broad-ranging, multidisciplinary and comparative research on Asian medicine in China, India, Japan, Mongolia, and Nepal Relevant to scholars, students, health professionals, and policy makers Includes extensive bibliographies of essential but little-known scholarship on Asian medicines from Asia

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Allosteric Modulation of G Protein-Coupled Receptors reviews fundamental information on G protein-coupled receptors (GPCRs) and allosteric modulation, presenting original research in the area and collectively providing a comprehensive description of key issues in GPCR allosteric modulation. The book provides background on core concepts of molecular pharmacology while also introducing the most important advances and studies in the area. It also discusses key methodologies. This is an essential book for researchers and advanced students engaged in pharmacology, toxicology and pharmaceutical sciences training and research. Many of the GPCR-targeted drugs released in the past decade have specifically worked via allosteric mechanisms. Unlike direct orthosteric-acting compounds that occupy a similar receptor site to that of endogenous ligands, allosteric modulators alter GPCR-dependent signaling at a site apart from the endogenous ligand. Recent methodological and analytical advances have greatly improved our ability to understand the signaling mechanisms of GPCRs. We now know that allostery is a common regulatory mechanism for all GPCRs and not - as we once believed - unique to a few receptor subfamilies.

Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients. Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-related healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution.