Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation. The benefit to Society is self-evident in that affordable treatments would be rapidly forthcoming. We have aggregated these phenomena into one topic "Pharmaco-complexity: Non-linear Phenomena and Drug Product Development".

Everyone expects something from the drug industry. Physicians and patients, investors, regulators and administrators all have an active interest. Everyone wants to know what makes drugs 'work' medically and economically. Why are drugs so expensive? Is it the drug companies or investors who demand high profits? What governs the pharmacoeconomics? Why are so few diseases treatable?
This book opens the windows and doors of the industry telling the story of drug development by using real stories from inside the process.
* Co-written by Graham Lees and Tamas Bartfai who has been involved in the development of drugs taken by more that 20 million people every day
* Opens the windows and doors of the most regulated industry in the world, the pharmaceutical industry
* Tells the story of drug development by using real examples based on current research and events
* Provides an objective, lucid account of the successes and failures, shortcomings and constraints of the pharmaceutical and biotech industries
* Gives insights into the development of new drugs to combat multiple conditions including cancer and pain
* Balanced, unbiased account of how better to translate basic science into drug discovery

Blockbuster drugs-each of which generates more than a billion dollars a year in revenue-have revolutionized the industry since the early 1980s, when sales of Tagamet alone transformed a minor Philadelphia-based firm into the world's ninth-largest pharmaceutical company. In Blockbuster Drugs, Jie Jack Li tells the fascinating stories behind the discovery and development of these highly lucrative medicines, while also exploring the tumult the industry now faces as the "patent cliff" nears. Having spent most of his career in drug research and development, Li brings an insider's eye to the narrative as he recounts the tales of discovery behind such drugs as Tagamet, Zantac, Claritin, Prilosec, Nexium, Serouquel, Plavix, and Ambien. As he discusses each breakthrough, Li also shows that scientific research is filled with human drama-serendipitous discoveries, sudden insights, tense confrontations. For instance, the author tells of James Black, who persisted in the research that led to Tagamet-and that would ultimately win him a Nobel Prize-despite pressure from top executives to pursue "more profitable" work. The book shows how research behind Prilosec combined creativity, international cooperation, and luck-the turning point being a chance encounter of American and Swedish scientists at a conference in Uppsala. There are also tales of fabulous rewards-George Rieveschl, the chemist who invented Benadryl, made a fortune on royalties-and of unjust desserts. Finally, Li shows that for the world's largest prescription drug manufacturers, recent years have been harrowing, as many popular drugs have come off patent in the U.S. market, meaning hundreds of billions of dollars in lost revenue. Anyone who enjoys tales of scientific discovery, or is curious about the history behind the prescriptions they take, or wants a revealing inside look at the pharmaceutical industry will find this book well worth reading.

Nervous System Drug Delivery: Principles and Practice helps users understand the nervous system physiology affecting drug delivery, the principles that underlie various drug delivery methods, and the appropriate application of drug delivery methods for drug- and disease-specific treatments. Researchers developing nervous system putative therapeutic agents will use this book to optimize drug delivery during preclinical assessment and to prepare for regulatory advancement of new agents. Clinicians will gain direct insights into pathophysiologic alterations that impact drug delivery and students and trainees will find this a critical resource for understanding and applying nervous system drug delivery techniques.

The Core Model: A Collaborative Paradigm for the Pharmaceutical Industry and Global Health Care develops the innovative core model, an organizational research and design paradigm and economic theory that proposes a collaborative approach to resolving global health issues and improving the productivity of drug development. The model proposes that scientific collaboration does not occur in an unstructured manner, but actually takes place within a highly structured order where knowledge is transferred, integrated and finally translated into commercial products. An understanding of this model will help solve the global pharmaceutical industrys productivity problems and address important global health care and economic issues. This book is useful to researchers, advanced students, regulators, and management in pharmaceutical industries, as well as healthcare professionals, those working in health economics, and those interested in scientific innovation processes.

Technological innovations have become the impetus for continuous developments in medical research. With the assistance of new technologies, effective drug delivery techniques have been improved for optimal patient care. Recent Advances in Drug Delivery Technology is a pivotal reference source for the latest scholarly research on the application of pharmaceutical technology to optimize techniques for drug delivery in patients. Focusing on novel approaches in pharmaceutical science, this book is ideally designed for medical practitioners, upper-level students, scientists, and researchers.

Pharmaceutics: Basic Principles and Application to Pharmacy Practice, Second Edition is a valuable textbook covering the role and application of pharmaceutics within pharmacy practice. This updated resource is geared toward meeting and incorporating the current curricular guidelines on pharmaceutics and laboratory skills mandated by the American Council for Pharmacy Education. It includes a number of student-friendly features, including chapter objectives and summaries, practical examples, case studies, numerous images and key-concept text boxes. Two new chapters are included, as well as a new end of chapter section covering "critical reflections and practice applications". Divided into three sections – Physical Principles and Properties of Pharmaceutics; Practical Aspects of Pharmaceutics; and Biological Applications of Pharmaceutics – this new edition covers all aspects of pharmaceutics and providing a single and compelling source for students.

New Look to Phytomedicine: Advancements in Herbal Products as Novel Drug Leads is a compilation of in-depth information on the phytopharmaceuticals used in modern medicine for the cure and management of difficult-to-treat and challenging diseases. Readers will find cutting-edge knowledge on the use of plant products with scientific validation, along with updates on advanced herbal medicine in pharmacokinetics and drug delivery. This authoritative book is a comprehensive collection of research based, scientific validations of bioactivities of plant products, such as anti-infective, anti-diabetic, anti-cancer, immune-modulatory and metabolic disorders presented by experts from across the globe. Step-by-step information is presented on chemistry, bioactivity and the functional aspects of biologically active compounds. In addition, the pharmacognosy of plant products with mechanistic descriptions of their actions, including pathogenicity is updated with information on the use of nanotechnology and molecular tools in relation to herbal drug research.

How often do we stop to recognize what pharmaceutical advertisements are telling us? Broadcast Pharmaceutical Advertising in the United States: Prime Time Pill Pushers engages with this question to include how pharmaceutical companies are shaping the meaning of drug interventions for individuals and the ways in which pharmaceutical advertisements frame issues of identity and representation for patients and health care. Such issues highlight how patients are being framed as consumers in these advertisements, which then permits the commodification of health care to be celebrated. Such a celebration has strong ideological implications, including definitions of "the good life," patient agency, and the role of DTCAs in such depictions. By defining and discussing medicalization, pharmaceuticalization, and commodity fetishism, this book introduces how the term "pharmaceutical fetishism" can act as a means for describing the commodification of brand-name pharmaceutical drugs, which, via advertising and promotional culture, ignores large-scale production and for-profit motives of "big pharma."

Eyecare Business: Marketing and Strategy will help you gain a competitive edge in the changing world of eyecare. Covers the basics of marketing, finance, strategy development, management, communication, and technology. Self-assessment exams serve as educational tools. Short teaching cases, clinical examples, and exercises help you adapt theory and concepts to your own practice. Action plans at the end of each chapter help jump-start the development of your own eyecare marketing program.

In the last quarter of the 20th century, politicians in Washington, as well as interest groups, regulatory policy makers, and drug industry leaders were forced to confront the hot-button issue of pharmaceutical regulation. The struggle always centered on product innovation, consumer protection, and choice in the free market. As the American economy stuttered in the late 1970s, the stakes were extremely high for the powerful drug industry and the American public. At the center of this drama was the Food and Drug Administration, which was censured from both the left and right of the political spectrum for being too strict and too lenient in the application of its regulatory powers. Lucas Richert explores the FDA, drugs, and politics in the context of the watershed Reagan era, a period when the rhetoric of limited government, reduced regulation, and enhanced cooperation between businesses and U.S. regulatory agencies was on the ascent. As he investigates the controversies surrounding Laetrile, Reye's Syndrome, Oraflex, patient package inserts, diet pills, and HIV/AIDS drugs, Richert argues that the practical application of conservative economic principles to the American drug industry was A Prescription for Scandal.

Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines.

In 1950, a diagnosis of cancer was all but a death sentence. Mortality rates only got worse, and as late as 1986, an article in the New England Journal of Medicine lamented: We are losing the war against cancer." Cancer is one of humankind's oldest and most persistent enemies it has been called the existential disease.But we are now entering a new, and more positive, phase in this long campaign. While cancer has not been cured,and a cure may elude us for a long time yet,there has been a revolution in our understanding of its nature. Years of brilliant science have revealed how this individualistic disease seizes control of the foundations of life,our genes,and produces guerrilla cells that can attack and elude treatments. Armed with those insights, scientists have been developing more effective weapons and producing better outcomes for patients. Paul A. Marks, MD, has been a leader in these efforts to finally control this devastating disease.Marks helped establish the strategy for the war on cancer" in 1971 as a researcher and member of President Nixon's cancer panel. As the president and chief executive officer for nineteen years at the world's pre-eminent cancer hospital, the Memorial Sloan-Kettering Cancer centre, he was instrumental in ending the years of futility. He also developed better therapies that promise a new era of cancer containment. Some cancers, like childhood leukemia and non-Hodgkin's lymphoma, that were once deadly conditions, are now survivable,even curable. New steps in prevention and early diagnosis are giving patients even more hope. On the Cancer Frontier is Marks' account of the transformation in our understanding of cancer and why there is growing optimism in our ability to stop it.

Prozac. Paxil. Zoloft. Turn on your television and you are likely to see a commercial for one of the many selective serotonin reuptake inhibitors (SSRIs) on the market. We hear a lot about them, but do we really understand how these drugs work and what risks are involved for anyone who uses them? Let Them Eat Prozac explores the history of SSRIs-from their early development to their latest marketing campaigns-and the controversies that surround them. Initially, they seemed like wonder drugs for those with mild to moderate depression. When Prozac was released in the late 1980s, David Healy was among the psychiatrists who prescribed it. But he soon observed that some of these patients became agitated and even attempted suicide. Could the new wonder drug actually be making patients worse? Healy draws on his own research and expertise to demonstrate the potential hazards associated with these drugs. He intersperses case histories with insider accounts of the research leading to the development and approval of SSRIs as a treatment for depression. Let Them Eat Prozac clearly demonstrates that the problems go much deeper than a side-effect of a particular drug. The pharmaceutical industry would like us to believe that SSRIs can safely treat depression, anxiety, and a host of other mental problems. But, as Let Them Eat Prozac reveals, this "cure" may be worse than the disease.

Evidence-Based Validation of Herbal Medicines brings together current thinking and practice in the areas of characterization and validation of natural products. This book reviews all aspects of evaluation and development of medicines from plant sources, including their cultivation, collection, phytochemical and phyto-pharmacological evaluation, and therapeutic potential. Emphasis is placed on describing the full range of evidence-based analytical and bio-analytical techniques used to characterize natural products, including -omic technologies, phyto-chemical analysis, hyphenated techniques, and many more.

This collection takes the perspective that the historiography of science, technology, and medicine needs a broader approach toward regulation. The authors explore the distinct social worlds involved in regulation, the forms of evidence and expertise mobilised, and means of intervention chosen to tame drugs in factories, consulting rooms and courts.

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. "Contract Research and Development Organizations: Their Role in Global Product Development" has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants.

Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs. "