As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol. Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region. Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.

Herbs and Healers from the Ancient Mediterranean through the Medieval West brings together eleven papers by leading scholars in ancient and medieval medicine and pharmacy. Fittingly, the volume honors Professor John M. Riddle, one of today's most respected medieval historians, whose career has been devoted to decoding the complexities of early medicine and pharmacy. "Herbs" in the title generally connotes drugs in ancient and medieval times; the essays here discuss interesting aspects of the challenges scholars face as they translate and interpret texts in several older languages. Some of the healers in the volume are named, such as Philotas of Amphissa, Gariopontus, and Constantine the African; many are anonymous and known only from their treatises on drugs and/or medicine. The volume's scope demonstrates the breadth of current research being undertaken in the field, examining both practical medical arts and medical theory from the ancient world into early modern times. It also includes a paper about a cutting-edge Internet-based system for ongoing academic collaboration. The essays in this volume reveal insightful research approaches and highlight new discoveries that will be of interest to the international academic community of classicists, medievalists, and early-modernists because of the scarcity of publications objectively evaluating long-lived traditions that have their origin in the world of the ancient Mediterranean.

Most clinical laboratory tests utilize interstitial and extravascular such as blood, urine, cerebral spinal fluid (CSF), and saliva. For example, CSF is monitored in the context of cancer for both diagnostic and therapeutic reasons. And yet, our understanding of the makeup of interstitial fluids, their relationships to disease, as well as their commercial importance in therapeutics and diagnostics remains rudimentary. Although sometimes perceived as static, interstitial and extravascular fluids are surprisingly dynamic. More than half of serum albumin is in the extravascular space. These fluids move rapidly between the intravascular and extravascular spaces - one entire plasma volume is exchanged very nine hours. In the first half of the book, the authors cover fundamental concepts of interstitial fluids, including their composition and function. They then further review the mechanisms by which interstitial fluids are regulated, characterizing the importance of hyaluronan - a major constituent of interstitial spaces and an a component of synovial fluid; and, outlining the regulation of proteolysis in the interstitial space. In the second half of the book, the authors focus on the coagulation system. This system has been studied extensively in the context of vascular spaces. But many of its components exist in the interstitial spaces. Chapters are devoted to the fibrinolytic system, kallikrein, matrix metalloproteinases, coagulation factors, and protease inhibitors - all are interstitial. By covering a unique array of topics with broad application to biomedical scientists, this book expands our understanding of the importance of interstitial spaces and the fluids that move through and reside in this extravascular environment.

Although numerous studies have been made of the Western educated political elite of colonial Nigeria in particular, and of Africa in general, very few have approached the study from a perspective that analyzes the impacts of indigenous institutions on the lives, values, and ideas of these individuals. This book is about the diachronic impact of indigenous and Western agencies in the upbringing, socialization, and careers of the colonial Igbo political elite of southeastern Nigeria. The thesis argues that the new elite manifests the continuity of traditions and culture and therefore their leadership values and the impact they brought on African society cannot be fully understood without looking closely at their lived experiences in those indigenous institutions where African life coheres. The key has been to explore this question at the level of biography, set in the context of a carefully reconstructed social history of the particular local communities surrounding the elite figures. It starts from an understanding of their family and village life, and moves forward striving to balance the familiar account of these individuals in public life, with an account of the ongoing influences from family, kinship, age grades, marriage and gender roles, secret societies, the church, local leaders and others. The result is not only a model of a new approach to African elite history, but also an argument about how to understand these emergent leaders and their peers as individuals who shared with their fellow Africans a dynamic and complex set of values that evolved over the six decades of colonialism.

The advancement of the life sciences and the technosciences has enhanced the longevity of citizens in the Western world, and half of the generation born in the first decade of the new millennium is now expected to live to the age of one hundred years. In a society with such longevity and affluence, consumption of health-related goods and services such as pharmaceuticals and scanning procedures may be seen as a sustainable source of income for the industries that promote it. Though the healthcare sector has traditionally been organized in the public sector in Europe and in the private sector in the US, the recent advancement of new therapies and direct-to-consumer marketing have opened up new streams of consumption and revenue for health care goods and services around the globe. This book examines the so-called 'bioeconomy' as a new economic and commercial field that emphasizes the management of individual life, including the regulation and control of weight and food consumption and other issues pertaining to individual well-being. In addition, the bioeconomy includes a variety of practices based on commercial interests such as organ donations, reproductive medicine and technologies, and what has been referred to as the tissue economy - the various forms of trade with human tissues. Author Alexander Styhre provides a thorough introduction to the bioeconomy, exploring this new and unique intersection of the life sciences and the technosciences with more traditional consumer markets.

Essential Practical Prescribing is an important new textbook with a clinical, ward-based focus. It is specifically designed to help new foundation doctors working on the hospital wards and in the community, as well as medical students preparing for the Prescribing Safety Assessment. Using an accessible format, Essential Practical Prescribing demonstrates how to manage common medical conditions, and explains the logic behind each decision. It also emphasises common pitfalls leading to drug errors, and highlights drugs that could cause harm in certain situations. Organised by hospital department, it outlines the correct management of conditions, as well as highlighting the typical trials of a junior doctor. Essential Practical Prescribing: * Contains a range of learning methods within each chapter including: key topics, learning objectives, case studies, DRUGS checklists, "Top-Tips", advice on guidelines and evidence, and key learning points * Uses patient histories to set the scene and enhance the clinical emphasis * Offers examples of correctly completed drug charts throughout, which are also available online * Is an ideal companion for Prescribing Safety Assessment (PSA) preparation * Includes a companion website at www.wileyessential.com/prescribing featuring MCQs and downloadable DRUGS checklists and drug charts

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.

This revised third edition has been updated to cover all aspects of chiral drugs from the academic, governmental industrial and clinical perspective reflecting the many advances in techniques and methodology. The title will cover new material including the use of enzymes for the synthesis and resolution of enantiomeric compounds as well, as their use in drug discovery; how stereochemistry impacts on decisions taken during the ADMET (absorption, distribution, metabolism, excretion, toxicity) stage of drug discovery; issues faced during the final stages of the drug development process; the impact of ICH (International Conference on Harmonisation) on the use of single isomer drugs; racemic switches; and legal perspectives looking at IP and patent issues surrounding chiral switches and marketing single enantiomer switches.

This Third Edition comprehensively presents all aspects of chiral drugs from scientific, academic, governmental, industrial, and clinical points of view. This one-stop text covers the lifespan of stereochemistry, from its early history, including an overview of terms and concepts, to the current drug development process, legal and regulatory issues, and the new stereoisomeric drugs.

New topics include:

• The use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug discovery
• How stereochemistry impacts decisions made in the Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) stages of drug discovery
• A chapter on pharmacokinetics and pharmacodynamics that discusses the issues faced during the final stages of the drug development process
• The impact of International Conference on Harmonisation on the use of single isomer drugs
• Chiral switches
• The concept of molecular chiral recognition and how it affects the separation and behavior of stereochemically pure drugs
• A chapter on the legal perspectives of patent issues surrounding chiral switches and the marketing of single enantiomer switches
• This will be a one-stop shop for pharmaceutical scientists and chemists working with chiral drug molecules
  

Modern technology using state-of-the-art equipment can now identify almost any toxin relevant to a legal issue. Techniques include gas chromatography, mass spectrometry, high-pressure liquid chromatography, and the combination of these methods. Forensic Toxicology: Medico-legal Case Studies demonstrates how the science of forensic toxicology acts as a bridge between medicine and law. Tracking the progression of toxicology findings from the laboratory to the courtroom, it prepares practicing toxicologists to write reports and testify at depositions and in court.

The book explains the organization of clinical laboratories and includes sections on accreditation, quality control, method validation, and other critical topics. It provides an overview of the U.S. legal system, describes the process of writing a toxicology report, and offers techniques for deposition and courtroom testimony.

Covering a broad range of topics, the book offers detailed analysis of situations ranging from the rare and unusual to those that toxicologists most often confront, including:

• Determining serum/blood ethanol levels
• Ethylene glycol poisoning
• Plant and animal toxins
• Alcohol intoxication and breathalyzer tests
• Synergistic effects of alcohol and drugs
• Prescription drug overdose
• Toxic torts
• Workers compensation issues

Written in an accessible and well-organized style, this volume is an essential guide for forensic toxicologists at all levels who need to understand how to best present the science of toxicology in the forensic arena.

This money-saving package includes the 3rd edition of Pharmacology: Principles and Applications?Text and Workbook.

Because enzyme-catalyzed reactions exhibit higher enantioselectivity, regioselectivity, substrate specificity, and stability, they require mild conditions to react while prompting higher reaction efficiency and product yields. Biocatalysis in the Pharmaceutical and Biotechnology Industries examines the use of catalysts to produce fine chemicals and chiral intermediates in a variety of pharmaceutical, agrochemical, and other biotechnological applications. Written by internationally recognized scientists in biocatalysis, the authors analyze the synthesis of chiral intermediates for over 60 brand-name pharmaceuticals for a wide range of drug therapies and treatments. From starting material to product, the chapters offer detailed mechanisms that show chiral intermediates and other by-products for each reaction-including hydrolytic, acylation, halogenation, esterification, dehalogenation, oxidation-reduction, oxygenation, hydroxylation, deamination, transamination, and C-C, C-N, C-O bonds formation. Cutting-edge topics include advanced methodologies for gene shuffling and directed evolution of biocatalysts; the custom engineering of enzymes; the use of microbial cells and isolated biocatalysts; the use of renewable starting materials; and generating novel molecules by combinatorial biocatalysis and high-throughput screening. Focusing on industrial applications, the book also considers factors such as bulk processes, instrumentation, solvent selection, and techniques for catalyst immobilization, reusability, and yield optimization throughout. Biocatalysis in the Pharmaceutical and Biotechnology Industries showcases the practical advantages and methodologies for using biocatalysts to develop and produce chiral pharmaceuticals and fine chemicals.

Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.

Since most therapeutic efforts have been predominantly focused on pharmaceuticals that target proteins, there is an unmet need to develop drugs that intercept cellular pathways that critically involve nucleic acids. Progress in the discovery of nucleic acid binding drugs naturally relies on the availability of analytical methods that assess the efficacy and nature of interactions between nucleic acids and their putative ligands. This progress can benefit tremendously from new methods that probe nucleic acid/ligand interactions both rapidly and quantitatively. A variety of novel methods for these studies have emerged in recent years, and Methods for Studying DNA/Drug Interactions highlights new and non-conventional methods for exploring nucleic acid/ligand interactions. Designed to present drug-developing companies with a survey of possible future techniques, the book compares their drawbacks and advantages with respect to commonly used tools. Perhaps more importantly, this book was written to inspire young scientists to continue to advance these methods into fruition, especially in light of current capabilities for assay miniaturization and enhanced sensitivity using microfluidics and nanomaterials.

A compilation of published scientific information, including human, animal, cellular, and theoretical studies, Depleted Uranium: Properties, Uses and Health Consequences provides the most current and comprehensive collection of information on depleted uranium health hazards. The editor and her international panel of contributors are clinical and basic researchers at the forefront of toxicology, carcinogenesis, and human epidemiology. They review key findings on DU biological and health effects and comprehensively describe the research progress made during the last 11 years. The book's coverage ranges from cellular malignant transformation and carcinogenesis to animal toxicity and neurotoxicity, and concludes with human medical surveillance studies, uranium measurement methodologies, risk modeling, and environmental modeling. The chapters provide information on cellular and animal studies, in vivo carcinogenesis, risk modeling, uranium measurement methodologies, medical surveillance programs, and environmental monitoring. Focusing on current, peer-reviewed data, this volume is the only available compilation book on the current understanding of the potential health hazards of depleted uranium exposure.

Although there are numerous books on drug metabolism, Radiotracers in Drug Development is unique in explaining how radiotracers are used to elucidate a drug's absorption, distribution, metabolism, and excretion (ADME). Covering traditional and recent technologies and applications, the book takes a strong industrial approach, discussing the basics of scintillation counting and untangling the various data processing methods often specific to individual manufacturers. The chapters include descriptions of the latest micro-plate counters and the growing applications of accelerator mass spectrometry, positron emission tomography, gamma-scintigraphy, and radioluminography. In addition to describing how the analytical technologies work, the contributors explain how the data are interpreted and used in the drug registration process. A unique reference and training aid essential for every drug metabolism department or drug metabolism research team, the book provides insight into the use and practice of ADME in a way that is both instructive and practical. Moving easily across the boundaries of biology, chemistry, and physics, this is the only comprehensive, interdisciplinary resource covering the how-tos of employing radiotracers in drug development. It provides detailed information on how the science is relevant to the registration process.

Ibuprofen is widely used throughout the world for a variety of conditions. This reference work provides a comprehensive and critical review of the basic science and clinical aspects of the drug. The book begins with the history and development of the drug and its current patterns of use world- wide before moving on to examine its basic pharmaceutical attributes and medicinal chemistry. The properties of various formulations are described (oral prescription and OTC, topical and others) are described. The pharmacokinetics of ibuprofen in animals and humans is discussed - highlighting the factors affecting absorption, distribution, metabolism and elimination. The clinical pharmacology and toxicology and the drug's mechanisms of action in different disease states and conditions are covered. The therapeutic uses in various acute and inflammatory conditions is detailed. Also considered are the safety versus efficacy issues and the pharmacoepidemiological data.

Encapsulation is a topic of interest across a wide range of scientific and industrial areas, from pharmaceutics to food and agriculture, for the protection and controlled release of various substances during transportation, storage, and consumption. Since encapsulated materials can be protected from external conditions, encapsulation enhances their stability and maintains their viability. This book offers a comprehensive review of conventional and modern methods for encapsulation. It covers various thermal and nonthermal encapsulation methods applied across a number of industries, including freeze drying, spray drying, spray chilling and spray cooling, electrospinning/electrospraying, osmotic dehydration, extrusion, air-suspension coating, pan coating, and vacuum drying. The book presents basic fundamentals, principles, and applications of each method, enabling the reader to gain extended knowledge. The choice of the most suitable encapsulation technique is based on the raw materials, the required size, and the desirable characteristics of the final products.

There is an estimated 2.5 million epileptics in the US and perhaps some 40 million worldwide. As research has become increasingly molecular in scope, fewer scientists are trained in the US on basic, integrated epilepsy techniques. One frustration in neuroscience today is the application of state-of-the-art molecular biology techniques to inappropriate animal models of epilepsy - frequently resulting in inconclusive results. Epilepsy research will be increasingly undertaken by scientists well-trained in reductionist methodology, but who may be unfamiliar with integrated, whole-animal techniques. This situation appears even more difficult considering there has been no updated textbook on experimental models of epilepsy over the last twenty years - until now. Neuropharmacology Methods in Epilepsy Research describes fundamental methodologies and procedures in this field, representing the only detailed text concerning experimental models of epilepsy published in the last 20 years. This guide studies the reproduction of well-characterized and readily interpretable experimental models of epilepsy to which state-of-the-art molecular biology techniques can be applied. Each chapter features: Introduction - providing a brief background and historical account of the techniques and their use Methodology - describing equipment, solutions, species, electrodes as well as considering variations of techniques and stimulation parameters Interpretations - demonstrating the relevance of techniques to epilepsy as well as describing what exactly is being studied and how the data is appropriately applied to understanding epilepsy Topics include electroshock, chemoconvulsions, kindling, audiogenic seizures, focal seizures, and brain slice preparations. Discussions also include: Recently developed seizure models, including status epilepticus and massed trial simulations Influence of circadian and diurnal rhythms on convulsive

Conducting studies of natural and man-made air contaminants is a specialized research activity that draws upon skills from a variety of disciplines including toxicology, pharmacology, industrial hygiene, and environmental health. Methods in Inhalation Toxicology describes how knowledge from these disciplines is integrated into the design and conduct of inhalation studies. Each of the vital aspects of conducting these studies is discussed in detail, including the use of animal subjects and the related quality control and ethical considerations, air purification methodology, exposure atmosphere generation and characterization, inhalation exposure systems, and real-time and post-exposure biological assessments. These methods will enable you to conduct inhalation studies, easily adding any specific measures of particular interest to your research. The book covers techniques needed to: provide suitable clean air for experiments correctly generate the particles and gases being studied select the proper exposure system monitor the exposure prepare tissues for study ensure that animals do not have confounding lung disease The helpful descriptions and detailed lists of suppliers of preferred equipment and materials will help you to perform valid, reproducible inhalation toxicology studies. Methods in Inhalation Toxicology is a perfect textbook for students in toxicology programs, as well as for scientists who conduct inhalation studies in both academic and industrial environments.

Genetic toxicology is considered to be an important assessment tool as there is genetic impact of artificial chemicals. Insight on Genotoxicity discusses testing, mechanism, prediction, and bioindicator of genotoxicity taking into consideration recent advances in nano-engineered particles. Corollary of DNA dent is also discussed in detail taking into consideration the impact of ICH guidelines on genotoxicity testing, which is important for drug discovery innovation and development. Perspective review of genotoxicity evaluation in phytopharmaceuticals has been mentioned along with the prevention of genotoxicity in brief viewpoint. Salient Features Presents methods, standard protocols, and guidelines for genotoxicity testing Examines the impact of ICH Guidelines on genetic toxicity testing which is a regulatory requirement for drug discovery and development Defines appropriate strategies about advances in in vivo genotoxicity testing which have been listed along with progress and prospects Discusses advancement in the high-throughput approaches for genotoxicity testing Details computational prediction of genotoxicity with consideration of mutagenicity, chromosomal damage caused and strategies for computational prediction in drug development

What chemicals are poisonous to the heart and why are they toxic? Find out by reading Principles of Cardiac Toxicology. Certain chemicals can produce toxicity by interacting with elements of the cardiovascular system. This book presents the anatomical, physiological, biochemical, and pathological basis for this interaction and describes the classes of chemicals known to produce cardiovascular toxicity. Characteristics of potential antidotes are also discussed. Clinicians and researchers will discover that this volume is an essential guide to understanding factors that could contribute to cardiovascular health and disease. Cardiologists, emergency room physicians, intensive care nurses, consulting pharmacists, and basic medical scientists will also benefit from this comprehensive work.

Together, the nano explosion and the genomic revolution are ushering in a new frontier in drug delivery. In recent years we've seen how polymers can play a crucial role in controlling the rate of drug release, enhancing solubility and uptake, and limiting degradation and toxicity. In the very near future, they may well be used to deliver gene therapy. While Polymers in Drug Delivery offers much new insight for the veteran specialist, this work has been compiled with the non-specialist in mind. It includes contributions from many of the world's leading drug delivery specialists, yet avoids jargon and presents background information that initiates the next generation of scientists into the amazing work going on at the frontiers of this rapidly evolving science. Targeting specific issues at the forefront of drug delivery today, this engaging volume- * Outlines the issues that must be considered when selecting a polymer for fabricating a drug delivery agent or other medical devices * Explains the more commonly used methods by which polymers may be characterized prior to use * Profiles polymer matrices that have been used in the formulation of solid oral dosage forms, drug delivery scaffolds, and hydrogels * Examines the issues surrounding the encapsulation of biologics within microspheres * Explores the use of nanoparticulates, especially solid nanoparticles and nanocapsules prepared from largely-water-insoluble cyanoacrylate polymers * Discusses polymeric micelles and investigates the potential of soluble polymer prodrugs and polymer nanomedicines * Details the contribution made by polymers and dendrimers to the gene delivery effort, which may one day lead to effective treatments for largely incurable diseases Noting a dramatic paradigm shift that is bridging the gap between materials science and life science, the editor's have compiled this volume to paint an interdisciplinary portrait of drug delivery that will challenge young scientists to turn their attention and effort towards this critical branch of biomedicine. Containing state-of-the-art information for drug delivery scientists, it is also a great choice for medical and pharmaceutical students and others seeking an in-depth introduction to the field.

Reviews in Food and Nutrition Toxicity, Volume 4 includes the most recent reviews of current issues involved in the toxicity of food and nutrients. With contributors from the fields of medicine, public health, and environmental science, the continuation of this series distills a broad range of research on food safety and food technology. Volume Four discusses: The extent to which postnatal metal exposure through breastfeeding can impair an infant's health Selenium bioavailability and metabolism, effects of selenium exposure, and mechanisms of selenium toxicity The fate of toxic and nontoxic arsenic compounds in the human body upon ingestion The biological role of sulfur, sulfur metabolism, deficiencies, and toxicity The effects on fluoride on teeth, bones, kidneys, arteries, hormones, the brain, and the reproductive system Food-borne disease outbreaks, microbial quality and risk assessment of food-borne microorganisms in ready to eat foods Effect of T-2 toxin on DNA and chromosomes, circulatory system, skin, reproductive system, liver and spleen, gastrointestinal tract, brain and neurotransmitters, and more Investigation of the interference of AFB1 with molecular components of cell cycle checkpoints Analyzes cycad consumption and its effects on the neurological systems and its manifestations; describes bio-chemical changes and morphological or pathological outcomes through time in detail Lectins in the human diet, toxicity and biological effects, immunomodulatory effects, modulation of immune function by dietary lectins in disease This is a valuable resource for anyone involved in the food industry or academics researching food science and food technology.

Laboratory automation is an increasingly important part of the job description of many laboratory scientists. Although many laboratory scientists understand the methods and principles involved in automation, most lack the necessary engineering and programming skills needed to successfully automate or interface equipment in the lab. A step-by-step, how-to reference and guide, Practical Pharmaceutical Laboratory Automation explores the processes needed to automate the majority of tasks required in research today. The author discusses topics ranging from automated mathematical analysis to robotic automation of chemical processes, to combinations of these and other processes. He presents a detailed discussion of high throughput screening and assay development and takes an in-depth look at Visual Basic as the primary programming language used in laboratories. The text has a dedicated web site (http://www.pharmalabauto.com) that contains all the sample code and examples contained within the text as well as other information related to laboratory automation. Providing a starting point for tackling automation problems, Practical Pharmaceutical Laboratory Automation helps you develop a strategy for automation that gets consistent results.