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.

The inspiration behind the Netflix tv series Painkillers, starring Uzo Aduba and Matthew Broderick THE SUNDAY TIMES BESTSELLER Now on BBC Radio 4 'Book of the Week' Winner of the 2021 Baillie Gifford Prize for Non-Fiction Shortlisted for the 2021 Financial Times/McKinsey Business Book of the Year Award One of Barack Obama's Favorite Books of 2021 Shortlisted for the Crime Writers' Association Gold Dagger for Non-Fiction The gripping and shocking story of three generations of the Sackler family and their roles in the stories of Valium, OxyContin and the opioid crisis. 'One of those authors I will always read, no matter what the subject matter, which is why I gobbled up Empire of Pain . . . a masterclass in compelling narrative nonfiction.' - Elizabeth Day, The Guardian '30 Best Summer Reads' 'You feel almost guilty for enjoying it so much' - The Times 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, award-winning journalist and host of the Wind of Change podcast Patrick Radden Keefe exhaustively documents the jaw-dropping and ferociously compelling reality. Empire of Pain is the story of a dynasty: a parable of twenty-first-century greed.

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.

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.

Bioinspired and Biomimetic Materials for Drug Delivery delves into the potential of bioinspired materials in drug delivery, detailing each material type and its latest developments. In the last decade, biomimetic and bioinspired materials and technology has garnered increased attention in drug delivery research. Various material types including polymer, small molecular, protein, peptide, cholesterol, polysaccharide, nano-crystal and hybrid materials are widely considered in drug delivery research. However, biomimetic and bioinspired materials and technology have shown promising results for use in therapeutics, due to their high biocompatibility and reduced immunogenicity. Such materials include dopamine, extracellular exosome, bile acids, ionic liquids, and red blood cell. This book covers each of these materials in detail, reviewing their potential and usage in drug delivery. As such, this book will be a great source of information for biomaterials scientists, biomedical engineers and those working in pharmaceutical research.

Pharmaceuticals in Marine and Coastal Environments: Occurrence, Effects, and Challenges in a Changing World is divided into three sections that address a) coastal areas as the main entrance of pharmaceuticals into the ocean, b) the occurrence and distribution of pharmaceuticals in the environmental compartments of the ocean media, and c) the effects that such pollutants may cause to the exposed marine organisms. With its comprehensive discussions, the book provides a wide depiction of the current state-of-the-art on these topics in an effort to open new sources of investigation and find suitable solutions.

Pharmacy Practice Research Case Studies provides examples and details regarding how pharmacy practice research has transformed over the past decade and how this is impacting overall health. This book presents several methodologies and techniques used in current pharmacy practice. According to the United Nations Sustainable Development Goals, countries around the world are aiming to achieve Universal Health Coverage. In this context, pharmacists are a vital part of the healthcare teams and the book portrays the research methods used in conducting pharmacy practice and medicines use research. The professional role of pharmacists has evolved tremendously over the past few decades across the globe and the pace of change has been interestingly phenomenal in varying aspects. The book provides a great resource for pharmacists, pharmaceutical scientists, policymakers, and researchers to understand the dimensions of practice, education, research, and policy concerning pharmacy, and it provides the synthesis of the development so far, pointing to the needs and demands of the future.

Theory and Applications of Nonparenteral Nanomedicines presents thoroughly analysed data and results regarding the potential of nanomedicines conceived by diverse non-parenteral routes. In the context of nanotechnology-based approaches, various routes such as oral, pulmonary, transdermal, delivery and local administration of nanomedicine have been utilized for the delivery of nanomedicine. This book discusses the non-parenteral application of nanomedicine, its regulatory implications, application of mucus penetrating nanocarrier, and detailed chapters on development of nanomedicines developed for drug delivery by various route. Beginning with a brief introduction to the non-parenteral delivery of nanomedicine and the safety and regulatory implications of the nanoformulations, further chapters discuss the physiology of the biological barriers, the specificity of the nanocarriers as well as their multiple applications. Theory and Applications of Nonparenteral Nanomedicines helps clinical researchers, researchers working in pharmaceutical industries, graduate students, and anyone working in the development of non-parenteral nanomedicines to understand the recent progress in the design and development of nanoformulations compatible with non-parenteral applications.

Drug Delivery Devices and Therapeutic Systems examines the current technology and innovations moving drug delivery systems (DDS) forward. The book provides an overview on the therapeutic use of drug delivery devices, including design, applications, and a description of the design of each device. While other books focus on the therapy, the primary emphasis in this book is on current technologies for DDS applications, including microfluidics, nanotechnology, biodegradable hydrogel and microneedles, with a special emphasis on wearable DDS. As part of the Developments in Biomedical Engineering and Bioelectronics series, this book is written by experts in the field and informed with information directly from manufacturers. Pharmaceutical scientists, medical researchers, biomedical engineers and clinical professionals will find this an essential reference.

Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book.

Polymer-Drug Conjugates: Linker Chemistry, Protocols and Applications discusses important concepts, fundamentals and prospective applications of 'Linker Chemistry' in a clear-and-concise manner. The book provides vital information on chemical entities binding with the drug-polymer complex for targeted drug delivery systems. It highlights roles and significance, different classes and synthetic protocols as well as mechanisms of chemical bond formation in drug-polymer conjugation in drug delivery, also offering insights into the mechanism of polymer interaction with linker and drug molecules by biodegradable chemical bonding. The protocol of binding with drug molecules is clearly explained and justified with case studies, helping researchers and advanced students in the pharmaceutical sciences understand fundamentals involved and related aspects in molecule designing for effective therapeutic benefits.

Overcoming Obstacles in Drug Discovery and Development uses real-world case studies to illustrate how critical thinking and problem solving skills are applied in the discovery and development of drugs. It also shows how developing critical thinking to overcome issues plays an essential role in the process. Modern drug discovery and development is a highly complex undertaking that requires scientific and professional expertise to be successful. After the identification of a molecular entity for treating a medical condition, challenges inevitably arise during the subsequent development to understand and characterize the biological profile; feedback from scientists is used to fine-tune the molecular entity to obtain an effective and safe product. In this process, the discovery team may identify unexpected safety issues and new medical disorders for treatment by the molecular entity. Invariably inherent in this complex undertaking are miscues, mistakes, and unexpected problems that can derail development and throw timetables into disarray, potentially leading to failure in the development of a medically useful drug. Addressing critical unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills. Overcoming Obstacles in Drug Discovery and Development will be essential to young scientists to help learn the skills to successfully face challenges, learn from mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from the case studies of successful and unsuccessful drug development.

Clinical Case Studies on Medication Safety provides real and simulated scenarios about safety issues related to medication, including Adverse Drug Reactions (ADRs), medication errors, and Drug Related Problems (DRPs). The book explains real-life case management, including details about adverse drug reactions, mistakes during drug administration, drug avoidance, and drug-drug interactions with a goal of improving patient care. With over 150 case studies, including cases from alternative medicine and traditional medicine, this book will help medical and health sciences educators, students, healthcare professionals, and other readers apply their knowledge and skills to solve cases for better patient care.

Formulation of Monoclonal Antibody Therapies: From Lab to Market covers a wide range of topics about therapeutic monoclonal antibodies (mAbs) with a focus on formulation aspects. Therapeutic monoclonal antibodies are used for treatment of chronic diseases. It brings together a comprehensive knowledge in one accessible volume. Starting with foundational information on monoclonal antibodies, the book then discusses the importance of biopharmaceutical products, monoclonal antibodies and biosimilars in treatment of chronic diseases, pharmaceutical aspects of mAbs, and how it can be administered. It also covers the industrial point of view and the clinical application of mAbs including in oncology, general medicine, rheumatology, hematology, dermatology, gastrointestinal tract, metabolic diseases, and dentistry. Formulation of Monoclonal Antibody Therapies: From Lab to Market is essential reading for researchers in biotechnology and biopharmaceutical fields, academics and pharmaceutical industrial scientists, and university students in pharmaceutical and biopharmaceutical sciences.

A Handbook of Artificial Intelligence in Drug Delivery explores the use of Artificial Intelligence (AI) in drug delivery strategies. The book covers pharmaceutical AI and drug discovery challenges, Artificial Intelligence tools for drug research, AI enabled intelligent drug delivery systems and next generation novel therapeutics, broad utility of AI for designing novel micro/nanosystems for drug delivery, AI driven personalized medicine and Gene therapy, 3D Organ printing and tissue engineering, Advanced nanosystems based on AI principles (nanorobots, nanomachines), opportunities and challenges using artificial intelligence in ADME/Tox in drug development, commercialization and regulatory perspectives, ethics in AI, and more. This book will be useful to academic and industrial researchers interested in drug delivery, chemical biology, computational chemistry, medicinal chemistry and bioinformatics. The massive time and costs investments in drug research and development necessitate application of more innovative techniques and smart strategies.

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.