The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement,Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated, miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing, capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialized areas, such as inhalation toxicity studies. The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement, Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now-classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialised areas, such as inhalation toxicity studies.

Process-Induced Food Toxicants combines the analytical, health, and risk management issues relating to all of the currently known processing-induced toxins that may be present in common foods. It considers the different processing methods used in the manufacture of foods, including thermal treatment, drying, fermentation, preservation, fat processing, and high hydrostatic pressure processing, and the potential contaminants for each method. The book discusses the analysis, formation, mitigation, health risks, and risk management of each hazardous compound. Also discussed are new technologies and the impact of processing on nutrients and allergens.

This book presents an extensive study on the effectiveness of recent regulations on pharmaceutical prices in India, exploring the weaknesses in the design and implementation of pharmaceutical price controls and investigating what can be done to fix the broken system. In addition, it examines the extent to which essential medicines are actually made affordable by price controls. The book argues that companies make the pharmaceutical price control regime largely ineffective by coordinating to increase pre-regulation prices; by diversifying horizontally away from the regulated markets and increasing prices in the unregulated markets; by manipulating trade margins; and by refusing to comply with the regulation because the penalties remains negligible. The book draws on extensive empirical research involving India's 2013 Drug Price Control Order and widely-used medicines such as paracetamol and metformin to illustrate how firms have weakened regulation. It argues that the regulatory regime can be strengthened by using systematic analysis of product- and region-level data in the Indian pharmaceutical industry, and by screening for the strategies that firms currently employ to circumvent regulation. In closing, it discusses recent efforts to strengthen the implementation of price controls in India and expanding the scope of price controls to medical devices.

Substance Use Disorders: Assessment and Treatment is a summary of everything a therapist should know about substance abuse in one easy-to-read comprehensive book. The book begins with a discussion of the pharmacology of specific drug classes (opioids, hallucinogens, etc.) and the epidemiology of abuse. It then presents psychological theories of substance abuse, the initiation and progression of substance abuse disorders, issues of prevention and early intervention, and screening and assessment for substance abuse (including specific tests for assessment) and discusses in detail the various treatment methodologies available. Two final chapters explore issues relevant to special populations and legal and ethical considerations, regarding issues such as confidentiality and coerced treatment.
Key Features
* A synthesis of the current research and clinical literature
* Includes strengths and weaknesses of commonly used psychometric assessment measures
* Presentation and review of a complete Psychosocial/Substance Use Assessment form
* Discussion of treatment settings and criteria for placement decisions
* Discussion of treatment alternatives and effectiveness of major pharmacological and psychotherapeutic approaches
* Discussion of factors leading to Relapse, and components of Relapse Prevention programs

Medicinal Chemistry: Fundaments presents the cycle of the life of drugs, their physico-chemical properties, and consequences that arise in development. The fundamental concepts of Medicinal Chemistry (pharmacophore, prodrugs, Lipinsky rules) are also presented, including discussions on specific concerns of the European Pharmacopeia - the industrialist's bible - its role, and a description of the monographs of active principles.

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

Progress in Drug Research is a prestigious book series which provides extensive expert-written reviews on a wide spectrum of highly topical areas in current pharmaceutical and pharmacological research. Founded in 1959 by its current editor, the series has moved from its initial focus on medicinal chemistry to a much wider scope. Today it encompasses all fields concerned with the development of new therapeutic drugs and the elucidation of their mechanisms of action, reflecting the increasingly complex nature of modern drug research. Invited authors present their biological, chemical, biochemical, physiological, immunological, pharmaceutical, toxicological, pharmacological and clinical expertise in carefully written reviews and provide the newcomer and the specialist alike with an up-to-date comprehensive list of prime references. Each volume of Progress in Drug Research contains fully cross-referencing indices which link the books together, forming a virtually encyclopaedic work. The series thus serves as an important, time-saving source of information for researchers concerned with drug research and all those who need to keep abreast of the many recent developments in the quest for new and better medicines.

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation.

Psychiatry today is a barren tundra, writes medical historian Edward Shorter, where drugs that don't work are used to treat diseases that don't exist. In this provocative volume, Shorter illuminates this dismal landscape, in a revealing account of why psychiatry is "losing ground" in the struggle to treat depression.
Naturally, the book looks at such culprits as the pharmaceutical industry, which is not inclined to market drugs once the patent expires, leading to the endless introduction of new--but not necessarily better--drugs. But the heart of the book focuses on an unexpected villain: the FDA, the very agency charged with ensuring drug safety and effectiveness. Shorter describes how the FDA permits companies to test new products only against placebo. If you can beat sugar pills, you get your drug licensed, whether or not it is actually better than (or even as good as) current medications, thus sweeping from the shelves drugs that may be superior but have lost patent protection. The book also examines the FDA's early power struggles against the drug industry, an influence-grab that had little to do with science, and which left barbiturates, opiates, and amphetamines all underprescribed, despite the fact that under careful supervision they are better at treating depression, with fewer side effects, than the newer drugs in the Prozac family. Shorter also castigates academia, showing how two forms of depression, melancholia and nonmelancholia--"as different from each other as chalk and cheese"--became squeezed into one dubious classification, major depression, which was essentially a political artifact born of academic infighting.
An astonishing and troubling look at modern psychiatry, Losing Ground is a book that is sure to spark controversy for years to come.

Drug Targeting and Stimuli Sensitive Drug Delivery Systems covers recent advances in the area of stimuli sensitive drug delivery systems, providing an up-to-date overview of the physical, chemical, biological and multistimuli-responsive nanosystems. In addition, the book presents an analysis of clinical status for different types of nanoplatforms. Written by an internationally diverse group of researchers, it is an important reference resource for both biomaterials scientists and those working in the pharmaceutical industry who are looking to help create more effective drug delivery systems.

The book deals with the subject of depression and its causes and answers a number of questions that should be of interest to any and every patient regarding the health-care system and the society in general. Why has the diagnosis of depression increased over the past two decades? Are treatments offered to patients by their primary care physicians and psychiatrists justified and evidence based? Why do patients use nutritional and herbal supplements and are attracted to other complementary therapies? How do pharmaceutical companies exploit the health-care system and influence physicians to prescribe not the most effective but most expensive medicines? What is St. John's wort, and who has been using this unassuming weed for health benefits? The effectiveness of antidepressant drugs, both typical and newer drug classes, like SSRIs and SNRIs, and their adverse effects have been presented. The author has made head-to-head comparisons of scientific studies of St. John's wort with SSRIs, such as Prozac, Paxil, and Zoloft, for their effectiveness, adverse effects, and potentials for drug interactions in cogent and easily understood manner. The author leaves the reader with a take-home message as he concludes this book.

The Nature and Use of Ecotoxicological Evidence: Natural Science, Statistics, Psychology, and Sociology examines how toxicologists and environmental professionals come to understand and make decisions about possible harm from pollutants. Drawing on concepts and techniques from the natural, social and mathematical sciences, the book emphasizes how pollutant-related evidence is gathered, assessed, communicated and applied in decision-making. Each chapter begins with a real-world example before exploring fundamental cognitive, social, statistical or natural science concepts to explain the opening example. Methods from other disciplines for recognizing, reducing or removing the influence of impediments in wise decision-making are highlighted in each chapter. Misreading evidence by the scientific community, and miscommunication to regulators and the public, remain major impediments to wise action in pollution issues. Which evidence comes to dominate the dialogue among scientists, regulators and decision makers depends on social and scientific dynamics. Yet psychological and sociological factors that influence the movement of evidence through scientific communities to regulators receive cursory discussion by professionals unfamiliar with the sociology literature. Toxicologists, environmental scientists, psychologists and professionals and students across the sciences will find the book useful for understanding how evidence is generated, assessed and communicated in their own fields.

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.

Lipid Nanocarriers for Drug Targeting presents recent advances in the area of lipid nanocarriers. The book focuses on cationic lipid nanocarriers, solid lipid nanocarriers, liposomes, thermosensitive vesicles, and cubosomes, with applications in phototherapy, cosmetic and others. As the first book related to lipid nanocarriers and their direct implication in pharmaceutical nanotechnology, this important reference resource is ideal for biomaterials scientists and those working in the medical and pharmaceutical industries that want to learn more on how lipids can be used to create more effective drug delivery systems.

Providing optimal care to patients is a primary concern in the healthcare field. By utilizing the latest resources and research in biomedical applications, the needs and expectations of patients can be successfully exceeded. Novel Approaches for Drug Delivery is an authoritative reference source for the latest scholarly research on emerging developments within the pharmaceutical industry, examining the current state and future directions of drug delivery systems. Highlighting therapeutic applications, predictive toxicology, and risk assessment perspectives, this book is ideally designed for medical practitioners, pharmacists, graduate-level students, scientists, and researchers.