The gripping and shocking story of three generations of the Sackler family and their roles in the stories of Valium and Oxycontin, by the prize-winning, bestselling author of Say Nothing.

The Sackler name adorns the walls of many storied institutions – Harvard; the Metropolitan Museum of Art; Oxford; the Louvre. They are one of the richest families in the world, known for their lavish donations in the arts and the sciences. The source of the family fortune was vague, however, until it emerged that the Sacklers were responsible for making and marketing Oxycontin, a blockbuster painkiller that was a catalyst for the opioid crisis-an international epidemic of drug addiction which has killed nearly half a million people.

In this masterpiece of narrative reporting and writing, Patrick Radden Keefe exhaustively documents the jaw-dropping and ferociously compelling reality. Empire of Pain is the story of a dynasty: a parable of 21st century greed.

Now in its third edition, Pharmacology in Clinical Practice has been updated to ensure it remains up-to-date and relevant.

Particular care has been taken to simplify and clarify difficult concepts by explaining the links between pharmacology and physiology by providing definitions of new concepts, and using plain language for ease of understanding. Fundamental concepts, such as pharmacodynamics and pharmacokinetics, are well covered in a matter that is accessible and clear. Individual chapters cover the various systems of the body.

Updates include:

• A colour plate to illustrate the links between pharmacology and physiology
• Additional information on side-effects, contra-indications and patient education for groups of drugs
• A guide on how to access this information, to assist with exam preparation and nursing practice
• An updated chapter on nursing management of drug preparations and treatment
• An updated chapter on clinical applications
• A chapter on the legal framework for dispensing and prescribing.

Advanced Nanoformulations: Theranostic Nanosystems, Volume Three 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.

Drug Delivery Systems for Metabolic Disorders presents the most recent developments on the targeted delivery of drugs to deal with metabolic disorders in a safe, compliant and continuous way. The book covers recent developments in advanced drug delivery systems in various metabolic disorders, including disturbances in protein, lipid, carbohydrate and hormone metabolism and lysosomal and mitochondrial disorders. It provides a brief introduction to metabolic disorders, along with a focus on the current landscape and trends in understanding disease pathology using different in vitro and in vivo models required for clinical applications and developments of new therapeutics. Each subsequent chapter covers drug delivery systems dedicated to metabolic diseases caused by disturbances in protein, lipid, carbohydrate and hormone metabolism. Then, it moves on to cover lysosomal storage disorders and applications of phytopharmaceuticals in this context. This is the perfect reference for researchers in pharmaceutical science who are interested in developing new treatments for metabolic diseases.

Targeted Nanomedicine for Breast Cancer Therapy provides a compilation of treatment approaches for breast cancer, including conventional receptor targeting methods and novel strategies like stimuli responsive methods and tumor micro-environment responsive strategies. This book compiles the most important information on the state-of-the-art therapeutics, including breast cancer biomarkers and design principles of bio-responsive nanosystems. Presented in two parts, sections cover basic and receptor mediated targeting approaches and examine tumor microenvironment mediated approaches. This is a useful book for pharmaceutical scientists and basic and clinical scientists working in the research area of breast cancer and drug discovery both from academics and industry. Worldwide, breast cancer is the most common cancer in women, however, breast cancer therapy is always challenging. This book aims to help researchers remain updated on the most targeted nanomedicine research available.

Tamoxifen Tales: Suggestions for Scientific Survival presents a case study describing the academic journey of teams behind major advances in medical sciences, highlighting lessons learned that are applicable to the next generation of scientists. This book provides a manual on the successful mentoring of young scientists, including stories describing how training experience shaped careers to become leaders in academia and the pharmaceutical industry. The book documents Professor V. Craig Jordan's 50-year career in medical sciences that led to the discovery and development of Selective Estrogen Receptor Modulators (SERMs), which became the standard of women's healthcare around the world. Additionally, it illustrates the versatility of a scientist with a commitment to serving societies. This important resource will be a useful and interesting book for established medical scientists, research mentors and advanced students wanting to chart a successful and impactful research career.

Herbal Bioactive-Based Drug Delivery Systems: Challenges and Opportunities provides a wide-ranging, in-depth resource for herbal bioactives, including detailed discussion of standardization and regulations. The book first explores specific drug delivery systems such as gastrointestinal, ocular, pulmonary, transdermal, and vaginal and rectal. It then discusses novel applications for nano, cosmetics, nutraceuticals, wound healing and cancer treatment. Finally, there is a section focusing on standardization and regulation which includes an enhancement of properties. This book is an essential resource for pharmacologists, pharmaceutical scientists, material scientists, botanists, and all those interested in natural products and drug delivery systems developments.

Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering.

This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. Before the orphan drug legislation enacted in the US in 1983, there was a limited interest from industry to develop treatment for very small patient groups. One of the difficulties is, of course, that similar levels of investment are needed from a pharmaceutical company to bring a drug to the market for both small and large patient groups.
The journey from application of an orphan drug designation to a reimbursed market- approved drug is long and many obstacles occur during the journey.
After reading the book, readers will: Understand who the players/stakeholders are in the rare orphan disease field and their specific needs and concerns: patients and patient organizations, researchers and treating physicians within the field, industry, regulatory and reimbursement bodies* Understand the strong partnership between the different players and the various initiatives to improve and increase access to treatment for patients; minimizing the gap between numbers of known diseases, orphan designations, approved drugs and paid drugs.
The book also provides short practical case stories from patients and researchers, as well as representatives from industry and authorities on the challenges they came across in developing orphan drugs or getting access to orphan drugs.
A comprehensive overview of strategy, key activities and considerations of how to bring an orphan drug from concept to the market and make it available to patientsA source of updated information, news and trends for those who are already active in this fast-evolving fieldCovers the global definitions and the criteria for getting an orphan drug designation in, for example, the US and Europe

Patently innovative provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products.
Includes empirical research to relate innovation to drug lawA multidisciplinary approach is taken, including the intersection of IP (intellectual property) law, drug law and innovationDiscusses the impact of government regulation on firm innovation

This introductory textbook of pharmacoeconomics is ideal for all those working in, aspiring to work in or interested in the pharmaceutical industry. It assumes no prior knowledge of this subject but is written at a level appropriate, for example, for those studying for a postgraduate degree or diploma in pharmaceutical medicine and who already have a first degree in science or medicine. Emphasizes how pharmacoeconomics can be of assistance in "real world" decision making. Covers the development of insuring, financing and delivery of health care in the developed world and the increasing role of governments. Explains the trend towards the critical scrutiny of health service activity. All topics explained assuming no specialist knowledge.

To understand technological dependence and self-reliance in the manufacturing industries of the Third World, Sahu tests the main propositions of the two theories on technology transfer. He focuses particularly on understanding the shifting bargaining power of the multinationals, the state and private national capital; the process of acquisition, assimilation, adaptation, and generation of technology at the firm level; the role of the public sector and state regulations and control in the development of technological capability and self-reliant development; the conditions—domestic and international—that allow a developing country to move from a situation of dependency to self-reliance; and the phenomenon of reverse flow of technology from the Third World. According to Sahu, dependency theory is inadequate because of its structural mode of analysis, which portrays dependency as a determinant international structure rather than as a set of shifting constraints within which states seek to maneuver. Though its single-cause explanation of technological dependence in the Third World is helpful in explaining the phenomenon of the technological gap between India and its technology suppliers, it does not explain the growing bargaining power of the state and the national capital vis-a-vis multinationals in the last two decades. But according to Professor Sahu, the more sophisticated and dynamic bargaining framework, which considers dependency to be one of the many possible outcomes of technology transfer, helps researchers better understand the changing situations of developing countries, particularly the Indian situation since the early 1970s. An important study for researchers and policy makers dealing with economic development in emerging markets, particularly India.

This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control. The author team comprises academic experts and private practitioners who analyse recent case law at both EU (and UK) and Member State levels - in the context of current issues and future trends, including those related to COVID-19 - and examine the impact of competition law on the behaviour of the pharmaceutical industry. The book carefully considers the balance between competition and innovation, as well as between competition and regulation. It concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed. Integrating an overview of competition law, IP law and pharmaceutical regulation, this book will be an ideal read for scholars and graduate students, as well as private and public practitioners interested in pharmaceutical and European law.

Smart Polymeric Nano-Constructs in Drug Delivery: Concept, Design and Therapeutic Applications provides a thorough discussion of the most state of the art material and polymer exploitations for the delivery of bioactive(s) as well as their current and clinical status. The book enables researchers to prepare a variety of smart drug delivery systems to investigate their properties as well as to discover their uses and applications. The novelty of this approach addresses an existing need of exhaustively understanding the potential of the materials including polymeric drug delivery systems that are smartly designed to deliver bioactive(s) into the body at targeted sites without showing side effects. The book is helpful for those in the health sector, specifically those developing nanomedicine using smart material-based nano-delivery systems. Polymers have unique co-operative properties that are not found with low-molecular-weight compounds along with their appealing physical and chemical properties, constituting the root of their success in drug delivery. Smart Polymeric Nano-Constructs in Drug Delivery: Concept, Design and Therapeutic Applications discusses smart and stimuli responsive polymers applicable in drug delivery, followed detailed information about various concepts and designing of polymeric novel drug delivery systems for treatment of various type of diseases, also discussing patents related to the field. The book helps readers to design and develop novel drug delivery systems based on smart materials for the effective delivery of bioactive that take advantage of recent advances in smart polymer-based strategies. It is useful to those in pharmaceutical sciences and related fields in developing new drug delivery systems.

Antioxidants Effects in Health: The Bright and the Dark Side examines the role that antioxidants play in a variety of health and disease situations. The book discusses antioxidants' historical evolution, their oxidative stress, and contains a detailed approach of 1) endogenous antioxidants, including endogenous sources, mechanisms of action, beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies; 2) synthetic antioxidants, including sources, chemistry, bioavailability, legal status, mechanisms of action, beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies; and 3) natural antioxidants, including sources, chemistry, bioavailability, mechanisms of action, possible prooxidant activity; beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies. Throughout the boo, the relationship of antioxidants with different beneficial and detrimental effects are examined, and the current controversies and future perspectives are addressed and explored. Antioxidants Effects in Health: The Bright and the Dark Side evaluates the current scientific evidence on antioxidant topics, focusing on endogenous antioxidants, naturally occurring antioxidants and synthetic antioxidants. It will be a helpful resource for pharmaceutical scientists, health professionals, those studying natural chemistry, phytochemistry, pharmacognosy, natural product synthesis, and experts in formulation of herbal and natural pharmaceuticals.

Soon to be the major motion picture Pain Hustlers starring Emily Blunt and Chris Evans streaming on Netflix ‘A pacey crime caper set against the backdrop of the opioid crisis . . . When I tell you that reading The Hard Sell is like watching a Scorsese film, you will assume I am exaggerating. Pick it up and tell me I’m wrong.' - Patrick Radden Keefe, The New York Times In the early 2000s, John Kapoor had already amassed a small fortune in pharmaceuticals when he founded Insys Therapeutics. A boom time for painkillers, he had developed a novel formulation of fentanyl, the most potent opioid on the market. Kapoor, a brilliant scientist with relentless business instincts, was eager to make the most of his innovation. But there was a problem: the drug was approved only for cancer patients in dire condition. So he recruited an avaricious team, who employed a variety of deceptive techniques, from falsifying patient records to deceiving insurance companies. Insys became a Wall Street sensation. That is, until insiders reached their breaking point and blew the whistle, sparking a sprawling investigation in the government’s fight to hold the drug industry accountable in the spread of addictive opioids. With colourful characters and true suspense, The Hard Sell lays bare the pharma playbook. Evan Hughes offers a bracing look not just at Insys, but at how opioids are sold at the point they first enter the national bloodstream – in the doctor’s office . . .

Medicinal Chemistry of Anticancer Drugs, Third Edition provides an updated resource for students and researchers from the point-of-view of medicinal chemistry and drug design, focusing on the mechanism of action of antitumor drugs from the molecular level, and on the relationship between chemical structure and chemical and biochemical reactivity of antitumor agents. The new edition includes updated sections on the hot topic of cancer immunotherapy, cancer polypharmacology, multitargeted cancer therapy, medicinal chemistry of cancer diagnosis, theragnostic anticancer agents, and pre-mRNA processing in cancer. Although many books are available that deal with clinical aspects of cancer chemotherapy, this book provides a unique and valuable perspective from the point-of-view of medicinal chemistry and drug design. It will be useful to undergraduate and postgraduate students of medicinal chemistry, pharmacology, biological chemistry, pharmacy and other health sciences. Researchers and practitioners will find a comprehensive treatment of the topic and a large number of references, reviews and primary literature.

Presenting detailed analysis of the industrialization and commercialization of pharmaceutical patents in China, this timely book explores a range of related topics including a comparison of the ideal and existing state of the pharmaceutical market and patent industrialization. It argues that the core purpose of the industrialization of pharmaceutical patents is to promote the development of the local pharmaceutical industry whist also protecting society's right to safe and effective medication. Chapters examine the special application issues of patent law in relation to the field of pharmaceuticals, compare the Chinese and American legal systems and their approach to pharmaceutical patents, and provide in depth political and legal analysis of the industry. James Hou suggests methods by which the Chinese legal system can seek to improve its governance of pharmaceutical patents and balance the conflicts of interest arising between new drug developers, established drug manufacturers and the end users. Featuring comprehensive coverage of patents in the Chinese pharmaceutical industry, this book will be a key resource for scholars and students of commercial, pharmaceutical and intellectual property law, whilst also being of interest to industry talents discovering the potential of their own innovations.

Coronavirus Drug Discovery, Volume Three: Druggable Targets and In Silico Update presents comprehensive information on drug discovery against COVID-19. Chapters in Part One of this volume describe the various druggable targets and associated signaling pathways for effective targeting of SARS-CoV-2. In Part Two, chapters discuss the various computational approaches and in silico studies against SARS-CoV-2. Written by global team of experts, this book is an excellent resource that will be extremely useful to drug developers, medicinal chemists, pharmaceutical companies in R&D, research institutes in both academia and industry, and the National Library of Medicines and Health. In addition, agencies such as the National Institutes of Health, Centers for Disease Control and Prevention, World Health Organization, European Medicines Agency, the US Food and Drug Administration, and all others involved in drug discovery against COVID-19 will find this book useful.

Evidence-Based Validation of Herbal Medicines: Translational Research on Botanicals brings together current thinking and practice in the characterization and validation of natural products. The book describes different approaches and techniques for evaluating the quality, safety and efficacy of herbal medicine, particularly methods to assess their activity and understand compounds responsible and their probable underlying mechanisms of action. This book brings together the views, expertise and experiences of scientific experts in the field of medicinal plant research, hence it will be useful for researcher who want to know more about the natural lead with their validation and also useful to exploit traditional medicines.

This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed. Adopting an interdisciplinary approach, McLennan draws on diverse areas of law, the science of synthetic biology and the history and sociology of science. She concludes that synthetic biology presents novel regulatory challenges relating to environmental risk, biosafety, biosecurity and intellectual property. These challenges arise from the uniqueness of the science, the nature of its communities of scientists (including citizen scientists or 'biobunks') and the uncertainty surrounding possible hazards. Some scientists see intellectual property protection as a way to push innovation forward (bioentrepreneurs), while others openly share synthetic biology tools such as BioBricks. By understanding the range of regulatory challenges, the book make a case for enhanced regulation that protects us from synthetic biology's risks, whilst capturing its potential to improve our world. Regulation of Synthetic Biology will be essential reading for academics and students in the social sciences and law, as well as for scientists working in synthetic biology, and policymakers in innovation, science and the regulation of these fields.

Vaccine development is a complex and time consuming process that differs from the development of conventional pharmaceuticals. Primarily, vaccines are intended for use in healthy individuals as a preventative measure, requiring a long and rigorous process of research and many years of testing and development prior to clinical trials and regulatory approval. The average time for the development of vaccines to clinical is 12 to 15 years. Vaccine Development: From Concept to Clinic is a detailed overview of the development of new vaccines, covering the entire process and addresses all classes of vaccines from a processing, development and regulatory viewpoint. Utilising successful case studies the book will provide insight to the issues scientists face when producing a vaccine, the steps involved and will serve as an ideal reference tool regarding state-of-the-art vaccine development. This book is an ideal companion for any researchers working in vaccine discovery and development or with an interest in the field.

Stimuli-Responsive Nanocarriers: Recent Advances in Tailor-Made Therapeutics compiles dispersed knowledge into a complete and comprehensive source to help researchers understand and progress stimuli-responsive nanocarriers. The book contains recent advancements made in the field of stimuli-responsive nanocarriers with their application in controlled drug delivery against various diseases. It focuses on the design, mechanism, construction, therapeutic application and future challenges of stimuli-responsive nanocarriers which will help new researchers in designing next generation tailor-made advanced therapeutics. Finally, the book covers future aspects and challenges present in the route of development of stimuli responsive nanocarriers for disease therapeutics. Various recent advances and biomedical applications assembled in this book will guide scientists on how to design and develop novel controlled drug release systems.