This book is a comprehensive review of the current state of digital innovation, Internet activity, and e-business in the life sciences arena and a practical guide for managers planning, developing, and implementing e-strategies in the pharmaceutical industry. The authors provide numerous examples of innovative, best practice and lay the strategic foundation for using e-business across the pharmaceutical value chain from drug discovery to physician promotion to direct-to-consumer marketing.

This book is intended for scientists, engineers, physicians, business people, and service providers at all levels who are interested in and support the process of life science commercialization. - The authors provide a hands-on template for success based on their years of experience practicing and teaching bioentrepreneurship and consulting to clients, students, economic development agencies, and faculty around the world.

Nanotechnology in Ophthalmology is a comprehensive and up-to-date reference on the role and applications of nanotechnology in ophthalmology, from drug delivery and treatment of ocular diseases to toxicity issues. Written by experts from the nanotechnology, ophthalmology, and pharmacology fields, this book has a unique, broad and diverse scope, including chapters on nanosensor-based diagnostic tools, delivery of nanobiomaterials, implantable materials and devices, delivery of nanobiomaterials, nanotechnology for medical and surgical treatment, regenerative medicine, and more. This book provides a valuable reference to researchers working in the areas of ophthalmology, nanoscience and pharmacology, and clinical fellows who are interested in nanoophthalmology as a reference for their practice and research.

The internationalization of research and technology is one key component of the globalization of trade and business, with potentially major impacts on patterns of economic development and public policies worldwide. Particularly in the already highly globalized pharmaceutical industry, innovation processes have changed considerably in the last 15 - 20 years. One-dimensional, linear single-actor type processes are being replaced by multi-dimensional, complex, multi-actor schemes. As a consequence, new players are becoming more important, with biotechnology firms playing a key role. This study analyzes these new ways in drug development in pharmaceuticals within the concept of "national systems of innovations" as well as from the perspectives of different actors, and collects a lot of empirical evidence for the assumed type of changes, its repercussion on significant input measures and on the differing performance of national pharmaceutical industries.

"This book reports empirical material from three case studies in the pharmaceutical industry, the biotechnology industry and the domain of academic research. New technoscientific frameworks that have not yet translated into new therapies, in the future, may play a more central role in the late-modern society"--

Licensing, Selling and Finance in the Pharmaceutical and Healthcare Industries is an assessment of the turbulent state of pharmaceutical and biotechnology markets as we enter the second decade of the 21st Century. At the same time, the book offers a cautionary evaluation of the future financing of innovation in terms of what's gone wrong and how to succeed in the future. Martin Austin explores the challenge that the pharmaceutical (and related) industries face in terms of balancing short term, cost containment and expenditure control in areas such as internal research and development; whilst embracing in-licensing and the acquisition of innovative therapies to counteract their impending portfolio weaknesses in the mid to longer term. The first part of the book provides an engaging and convincing perspective on the context in which the industry currently finds itself; the second part is a pragmatic guide to commercialising your intellectual property; including how to recognise and value what you have as well as the new ways of working that you will need to adopt when negotiating, collaborating and contracting in partnership and alliance with others. Commentators have described in great detail the cocktail of commercial, clinical and social issues that threaten to overwhelm the pharmaceutical industry; Martin Austin's book offers a very distinctive perspective on these issues and their solution.

A Pharmacology Primer: Techniques for More Effective and Strategic Drug Discovery, Sixth Edition features the latest research surrounding the application of pharmacology in drug discovery in an effort to equip readers with a deeper understanding of complex and rapid changes in this field. Written by well-respected pharmacologist, Terry P. Kenakin, this primer is an indispensable resource for anyone involved in drug discovery. This edition has been reorganized for better flow and clarity and includes material on new technologies for screening (virtual, DNA encoded libraires, fragment-based) and a major section on phenotypic (target agnostic) screening for new leads and determination of drug targets. With full color illustrations as well as new examples throughout, this book remains a top reference for all industry and academic scientists and students directly involved in drug discovery or pharmacologic research. New material includes a discussion of the determination of target engagement, including numerous new ways to demonstrate the physical interaction of molecules with drug targets and new drug candidates such a mRNA, gene therapy, antibodies and information on CRISPR and genomics.

How are pharmaceutical technologies developed and controlled in our societies? To what extent should the availability of these technologies be determined by scientific experts, a democratic state, the interests of final users, or ethical principles? This unique collection brings together the work of social scientists, ethicists, lawyers, and policy analysts on regulation, ethics and innovation in the pharmaceutical industry. Regulatory systems and their implications for public health in North America, Europe, and developing countries are discussed, including case studies of norplant, interferon, and anti-fertility vaccines.

The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.

"This book shows why contests over intellectual property rights and access to affordable medicines emerged in the 1990s and how they have been resolved so far. It argues that the current arrangement mainly ensures wealth for some rather than health for all, and points to broader concerns related to governing intellectual property solely as capital"--Provided by publisher.

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals.

First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations.

Volume one presents:

A historical perspective of injectable drug therapy, common routes of administration, and biopharmaceutics of NCEs and NBEs.

An in-depth discussion on the preformulation and formulation of small and large molecules, including ophthalmic dosage forms.

A presentation of parenteral primary packaging options - glass and plastic containers, as well as elastomeric closures.

A definitive chapter on container-closure integrity.

New chapters on solubility and solubilization, formulation of depot delivery systems and biophysical/biochemical characterization of proteins.

Volume two presents:

Chapters on aseptic facility design, environmental monitoring, and cleanroom operations.

A comprehensive chapter on pharmaceutical water systems.

A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing.

A detailed chapter on processing of parenteral drug products (SVPs and LVPs).

Presentations on widely used sterilization technologies steam, gas / chemical, radiation, filtration and dry heat.

An in-depth chapter on lyophilization.

Volume three presents:

An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables.

Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing.

Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems.

New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.

This book examines the strategic aspects of outsourcing in relation to the firm. It provides a holistic view of the outsourcing process, starting with conceptualization, through to implementation and management of the process. Although the book is based on a case study of the pharmaceutical industry, the general principles derived from the Strategic Sourcing Model are generic in nature and the model can be applied to instances of outsourcing in other industries.

Americans seeking herbal medicines now face confusion and even danger. There is great potential for these medicines to improve the health of consumers--if current regulations can be revised!Herbal Medicine: Chaos in the Marketplace is a prize-winning critique of the regulation and business of herbal medicine in the United States. It is the first book that examines the big picture issues-it tells the story of how the present situation developed, looks at what it means for consumers, compares approaches taken in other industrialized countries, and recommends where we need to go from here. Convenient reference tables provide easy access to information.Concerns about herbal medicines are hitting the headlines regularly, yet no other book has examined the core issues in depth from a public health perspective. Herbal Medicine: Chaos in the Marketplace fills that gap. It is highly relevant today, and you'll find it will continue to be indispensable reading for years to come as the situation plays out.This balanced, unique, and insightful volume will add to your knowledge of herbal medicine regulation and its impact on consumer health by: framing the limitations of the current situation with brief examples reviewing the regulatory history of herbal medicines in the United States placing the situation in an international context by also examining regulations in Canada, Germany, France, and the United Kingdom illustrating the practical implications of U.S. regulations with six examples that demonstrate how herbal medicines could contribute more to consumer health--and the public health risks associated with the current regulatory situation analyzing the public health issues related to safety, research, clinical practice, consumer interests, business, media, and federal government offering key, high-impact recommendations for future policyConsumers, health care professionals, business people in the domestic and foreign herb industries, researchers, health plan executives, food and drug attorneys and policymakers, as well as educators and students, will all find this book essential to their understanding of the workings of the herbal medicine industry. Visit the author's website at http://www.herbalchaos.com

Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators. Contributors: R. Arnold, M.A. Bagley, B. Domeij, J. Drexl, R.C. Dreyfuss, C.R. Fackelmann, T. Imura, R. Iseki, N. Lee, R. Moufang, H. Ullrich

Our recent understanding of the cellular and molecular defects and the regulation of the apoptotic signalling pathways has resulted in rationally designed anticancer strategies and the development of novel agents that regulates apoptosis. A comprehensive review of all apoptotic-related anticancer therapies is not the purpose of this book. However, in the volume of this book with 11 chapters, we have described a number of novel apoptotic regulators that have shown promising value and also great feasibility for cancer treatment. These novel agents either occur naturally or are chemically synthesized. While we are excited about the discovery and development of these novel apoptotic regulators as potential anticancer agents, a degree of caution should be always borne in mind when interpreting the success of preclinical pro-apoptotic candidates since potential problems inevitably lie ahead. These problems usually include target specificity, unanticipated toxicity, compound stability, formulation issues, pharmacokinetic and pharmacodynamic profiles. Nevertheless, we believe that this collection of 11 chapters by established leaders in the area of apoptosis will be of great interest to not only academics working in the field of cancer research and apoptosis but also pharmaceutical and pharmacological industries that . We are looking forward to the further development to push these potential agents toward clinical stage.

Multicultural Pharmaceutical Education spotlights methods and theory on how to increase representation of minorities in pharmacy schools and practice settings. Many of the ideas presented in this book are unique, and all provide an opportunity for institutions with few minority students to greatly improve their recruitment and retention efforts geared toward these students. The contributing authors, representing all levels of academia--deans, undergraduate students, vice provosts, executive directors, a National Professor of the Year, and faculty members--have all had experience in some aspect of minority pharmaceutical education. It is through their practical experiences that they offer suggestions and commentary on pharmacy programs of study. Historical accounts or examples of success that could be emulated at other institutions are included. With the help of Multicultural Pharmaceutical Education, colleges and universities and their faculty can forge ahead in attracting and retaining minority students to their pharmacy programs and into the world of pharmacy practice. Structured around four major areas (foundation, commitment, actuation, and conclusion), the authors remove the option of traditional excuses of failure in this important area of education. All those involved in pharmacy education should read this book whether deans, admissions counselors, professors, or students. Multicultural Pharmaceutical Education provides an easy-to-read, practical and theoretical approach to improving the opportunity and quality of education that minority students can achieve in pharmaceutical programs.

This book critically investigates the patent protection of medication in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter "SSA" or "Africa"). The book outlines the systemic problems associated with the prevailing globalized patent regime and the regime's inability to promote access to life-saving medication at affordable prices in SSA. It argues that for pharmaceutical patents to retain their relevance in SSA countries, human development concepts must be integrated into global patent law- and policy-making. An integrative approach implies developing additional public health and human development exceptions/limitations to the exercise of patent rights with the goal of scaling up access to medication that can treat epidemics in SSA. By drawing on multiple perspectives of laws, institutions, practices, and politics, the book suggests that SSA countries adopt an evidence-based approach to implementing global patent standards in domestic jurisdictions. This evidence-based approach would include mechanisms like local need assessments and the use of empirical data to shape domestic patent law-making endeavors. The approach also implies revising patent rules and policies with a pro-poor and pro-health emphasis, so that medication will be more affordable and accessible to the citizens of SSA countries. It also suggests considering the opinions of individuals and pro-access institutions in enacting crucial pieces of health-related statutes in SSA countries. The approach in this book is sensitive to the public health needs of the citizens affected by epidemics and to the imperative of building local manufacturing facilities for pharmaceutical research and development in SSA.

This volume provides information on how to select and screen plants for their medicinal properties. It describes phytopharmacological techniques for extracting and qualitatively and quantitatively analyzing a plant's phytochemicals. After a detailed in vitro investigation including nutritional and anti-nutritional analyses, medicinal properties were tested with various in vivo models for anti-inflammatory, analgesic, anti-pyretic, anticancer and anti-diabetic properties, as well as wound healing, neurodegenerative diseases, etc. Compound identification and purification techniques include, among others, TLC and column chromatography, as well as molecular docking with specific proteins.

Pharmaceutical Economics begins with an investigation of the structure of the industry and its three main components: the research firms which produce innovative products; the generic drug industry and its expanding role; and the biotech industry, which is regarded as the future for pharmaceuticals. Further sections discuss topics including demand and incentives, pricing and regulation. Professor Comanor and Professor Schweitzer have selected the most significant articles by leading academics, in order to offer a blend of standard economic interpretations of pharmaceutical policy and important new topics including biosimilars, insurance coverage for pharmaceuticals, price-fixing and direct-to-consumer advertising. An authoritative new introduction by the editors provides an insightful guide to these important topics.