Completely revised and updated, this is the seventh edition of Levine's classic pharmacology textbook. Known for it's thorough coverage and intelligent organization, the book covers the basic principles of pharmacological interactions on the human body in a way that is useful for both undergraduate and graduate students. Beginning with historical perspectives, nomenclature and definitions, the topics broaden to include sites and mechanisms of drug actions and travel to sites of action, as well as termination and elimination. The book also includes drug response and time-response relationships, response variability, drug toxicity, drug abuse, drug dependence, and more.

Contents:
1. Introduction: Methods of Data Representation, Interpretation and Analysis 2. Selected Physical Properties of Molecules 3. Solubility 4. Factors Affecting Biological Formulations 5. Science of Flow 6. Principles and Applications of Surface Phenomena 7. Theory of Diffusion and Dissolution 8. Dosage from Development 9. Reaction Kinetics and Stability 10. Oral Routes of Delivery 11. Parenteral Routes of Delivery 13. Rectal and Vaginal Routes of Delivery 14. Ocular, Nasal, Optic and Pulmonary Routes of Delivery 15. Delivery of Biotechnology-based Pharmaceuticals

Brain Targeted Drug Delivery Systems: A Focus on Nanotechnology and Nanoparticulates provides a guide on nanoparticulates to both academic and industry researchers. The book discusses key points in the development of brain targeted drug delivery, summarizes available strategies, and considers the main problems and pitfalls evidenced in current studies on brain targeted drug delivery systems. As the brain is the most important organ in the human body, and disorders of the central nervous system (CNS) are the most serious threat to human life, this book highlights advances and new research in drug delivery methods to the brain.

Attracting the attention of the medical community, exhaled breath condensate is a completely non-invasive method for sampling secretions from the airways. Analysis of exhaled breath condensate is potentially useful for monitoring airway inflammation and in pharmacological therapy. With its non-invasive nature, this method may be suitable for longitudinal studies even in children and in patients with lung severe disease. New Perspectives in Monitoring Lung Inflammation provides an introduction to the analysis of exhaled breath condensate for monitoring lung inflammation. The book presents current knowledge on the physicochemical properties of exhaled breath condensate and its formation in the airways and covers important aspects of the methodology. It details markers, and classes of markers, of airway inflammation in separate chapters and discusses the use of the technique in adults and children. The text also reviews the implications for drug development and future research. The volume concludes with an overview of lung inflammation focusing on basic and clinical pharmacology of important mediators. Presenting a comprehensive view of exhaled breath condensate, the text explains how this method could play a major role in the diagnosis and therapy of lung diseases, and may launch a new era in respiratory medicine.

The spectacular advances of medicinal chemistry in the last few decades have been triggered by a greater understanding of cellular processes at the molecular level. The understanding of biochemical processes and diseases at molecular level has revolutionized the field. This volume summarizes recent developments in the area of biological inhibitors such as squalene epoxidase inhibitors, dual inhibitors of 5-lipoxygenase and cycloxgenase, inhibition of cholestrol biosynthesis, HIV proteinase inhibitors, nonpeptide antagonists at peptide receptors, and binding interaction of thyroid hormones.

Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features -Assists non-experts in this field design a test protocol and interpret the results -Covers in vitro and in vivo aspects of interactions between drugs and light -Explores the kinetic and chemical aspects of drug photodecomposition -Discusses the problems frequently encountered in photochemical stability testing -Provides guidance on how to address photosafetyassessments and labeling requirements of potentially photoreactive drugs -Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint -Offers specific guidance in photostability testing and screening of drug photoreactivity

Diversified physicochemical injuries trigger Charnoly body (CB) formation as pleomorphic, electron-dense, multi-lamellar stacks of nonfunctional mitochondrial membranes in the most vulnerable cell. Free radicals induce downregulation of mitochondrial DNA, microRNA, AgNOR, and epigenetics to trigger CB molecular pathogenesis. CB is eliminated by energy (ATP)-driven lysosome-dependent charnolophagy as a basic molecular mechanism of intracellular detoxification to prevent acute and chronic diseases. Accumulation of CB at the junction of axon hillock and charnolosome (CS) at the synapses causes cognitive impairments; whereas, nonspecific induction of CB causes GIT stress, myelosuppression, alopecia, neurotoxicity, cardiotoxicity, and infertility in multidrug-resistant malignancies. Hence, stem cell-specific CB, charnolophagy, and CS agonists/antagonists are introduced as novel charnolopharmacotherapeutics for the successful treatment of cardiovascular diseases, neurodegenerative diseases, infectious diseases, drug addiction, and cancer. Nanoparticles to improve drug delivery, CS exocytosis, and disease-specific spatiotemporal charnolosomics employing correlative and combinatorial bioinformatics boost mitochondrial bioenergetics through balanced diet, exercise, and antioxidants. The book will be of interest to medical scientists and practitioners.

Specialists drawn from industry, agency and academia explain the role of the various elements in the marketing communications process, and show how a reassessment of the marketing mix can result in a positive response to challenges imposed by a changing commercial environment.

Food and Nutritional Toxicology provides a broad overview of the chemicals in food that have the potential to produce adverse health effects. The book covers the impact on human health of food containing environmental contaminants or natural toxicants, food additives, the migration of chemicals from packaging materials into foods, and the persistence of feed and food contaminants in food products. Chapters address the adverse effects of nutrient excesses, the impact of contaminants on nutrient utilization, metabolism of food toxicants, and the relationship of the body's biologic defense mechanisms to such toxicants. The book includes discussions on the risk determination process, food safety regulation, and the current status of the regulatory processes. Presenting the general principles of toxicology, this authoritative reference enhances the understanding of foodborne intoxications, infections, and diseases linked to foods. This in-depth study establishes a solid background in the principles and prevention of foodborne disease and the regulation of food safety.

Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient's rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry's key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive's perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.

This title was first published in 2000: The discovery, in the 1930s and 1940s, of antibiotics revolutionized the practice of medicine. Beginning with the streptomycins and the penicillins, hundreds of antibiotics have been developed and have come into routine use for the management of infectious diseases, opportunistic infections and infections resulting from trauma. This cornucopia of anti-infective agents has created a number of problems, not the least of which is the organization of information concerning them. This Handbook contains records for all the major drugs currently used in the treatment of infection. Monographs are provided for 1600 anti-infective agents. For each main entry, the following information is provided: the chemical name and a list of proprietary names and synonyms; the Chemical Abstracts Service (CAS) Registry Number; the European Inventory of Existing Commercial Chemical Substances (EINECS) number; and the Merck Index (12th edition) number. The physical properties of each compound are described and the known biological activity and indicated applications are presented. The structure of each compound is provided, together with a summary of the acute toxicity data associated with it, and the manufacturers and suppliers of the drug are also given. Indexes, including a master index of names and synonyms, are appended.

Molecular Toxicology is a concise introduction to the subject, taking the reader through the theoretical principles of toxicology followed by specific examples. In the first section, the concepts behind possible mechanisms of toxicity are described (e.g. the specific enzyme or receptor system) using examples where appropriate. Following this a series of examples are used to show the extension of concept into the real world, in an organ specific manner. The book concludes with a section outlining toxicity assessment methods, where the impact of molecular biology is having a considerable impact, including DNA microarrays, proteomics and bioinformatics. The Advanced Text series is designed for students taking advanced-level courses in life sciences, including final year undergraduates and taught MSc. Titles in this series will also be invaluable to researchers new to the field, and to established researchers as a basic reference.

The use of anabolic steroids in sport has become increasingly well documented over recent years. Controversy over nandrolone and EPO, and the suspicions surrounding their testing, continue to keep the subject in the headlines. Concern is growing, however, that the use of anabolic steroids outside competitive sport is becoming more widespread. Acknowledged by the EU as a public health issue, health professionals outside the sporting arena are increasingly being presented with evidence of steroid abuse amongst the general population.
This topical book brings together the key issues surrounding these contentious drugs - their mode of action, side effects, and the physiological and psychological risks and effects of overdose. Outlining the history and social context of these compunds, this book provides a comprehensive profile of the most commonly used steroids. Students and professionals in the fields of sport science, pharmacology, pharmacy, and a whole range of health sciences will find this a concise and engaging appraisal of the current situation regarding anabolic steroid use and abuse.

Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies. Updated and expanded, this second edition examines recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. The information provided outlines critical steps beginning from drug discovery in the laboratory to licensure and approval for market.

Biomedical research is an intrinsically changing and evolving field. A more direct strategy for drug discovery has gradually replaced random screening of natural products. More rapid identification of key molecular structures for new drug candidates and characterization of biomolecules including proteins, polysaccharides, and nucleic acids are now possible. The ability to chemically modify cell surfaces and carbohydrate linkages has facilitated designs of the next generation of new drugs. Thoroughly discussing these issues and more, Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition focuses on the latest developments in the science and regulation of bringing new drugs to market, including activities of the International Commission on Harmonization.

Drugs are used in the diagnosis, alleviation, treatment, prevention or cure of disease. This is a book about drugs, how they came to be, and how they exert their 'magic'. Today we have drugs to protect against infectious diseases, to alleviate aches and pains, to allow new organs to replace the old, and for brain functions to be modified. Yet, for the most part the manner by which drugs are developed and by whom remains a mystery. Drugs are more than just a pill or liquid and some have markedly altered history. The author has selected a few drugs - highlights representing milestones affecting our well-being and influencers of social change. The stories told are dramatic and include spectacular successes and dismal failures. And the people about whom these stories are told are both saints and sinners - selfless and conniving - bold and mercurial and shy and retiring loner. The drugs themselves mirror the diversity of their origin stories and the author assembles all sides of these fascinating stories. Key Selling Features: Chronicles the development of some of the most significant drugs affecting human health Offers easy-to-follow and understandable explanations of how drugs work Explains the science underlying the processes of drug discovery Helps readers appreciate the contributions of the individuals involved in drug discovery and development Serves as essential reading for anyone interested in human health and public policy

The vast literature devoted to phosphonate chemistry reflects an exciting field full of opportunities for research and development. As the field continues to advance, however, the time has come to consolidate the current body of knowledge into a concise, effective guide for the design and practice of phosphonate chemistry.

Modern Phosphonate Chemistry is a unique, up-to-date reference that summarizes the role of phosphonates in traditional and modern organic synthesis. In eight chapters, each devoted to a particular class of phosphonates, it details the relevant synthesis methods, chemistry, and properties or applications relevant to the corresponding reagent. The authors include 600 reaction schemes that provide practical guidance and more than 4600 references that offer a convenient gateway to the veritable mountain of published research.

It is now clear that functionalized phosphonates have a significant and growing role in organic synthesis as precursors of elaborated organic compounds, for the synthesis of complex, biologically important phosphonates, and in the synthesis of aminophosphonic acids and derivatives. Modern Phosphonate Chemistry is your first, and at present, only complete and practical resource focused exclusively on this dynamic field.

Pharmaceutical Process Validation, Third Edition explores the roots of pharmaceutical process validation originating in Switzerland and Germany in the 1980s. It covers troubleshooting procedures, validation in contract manufacturing, and harmonization trends. New chapters include Validation for Medical Devices, Validation of Biotechnology Processes, Transdermal Process Validation, Integrated Packaging Validation, Statistical Methods for Uniformity and Dissolution Testing, Change Control and SUPAC, Validation in Contract Manufacturing, and Harmonization, GMPs, and Validation. It includes contributions by research and industry specialists from the U.S., Europe, and Japan.

Family Therapy as an Alternative to Medication critically and passionately explores the concepts and practices that constitute the interface between family systems based psychotherapy and modern biological psychiatry. This diverse collection of essays, eight by psychiatrists, is neither for nor against medication, but takes a sceptical view of the unquestioned dominance that medication-based treatments have achieved among mental health practitioners. Its viewpoint is that therapeutic attention to context and relationships, regularly diminished when medications are prescribed, adds to maturity, expands consciousness, and impedes the development of psychiatric disorders. Clinical examples, by both practitioners and patients, are used to define potential problems that arise from trying to combine a medical model with family systems work and also illustrate the decision-making processes and methods for applying family systems based therapies. This book will stimulate thoughtful conversation among students and practitioners of all mental health disciplines.

Phoebe S. Prosky, MSW, studies under family therapy pioneer Nathan Ackerman, MD, and worked and taught at the Ackerman Institute of Family Therapy for fifteen years. She is Founder and Director of the Center for the Awareness of Pattern family therapy training center and clinic in Maine and has published numerous articles and chapters.

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Since the advent of cDNA microarrays, oligonucleotide array technology, and gene chip analysis, genomics has revolutionized the entire field of biomedical research. A byproduct of this revolution, toxicogenomics is a fast-rising star within toxicological analysis.

Gathering together leading authors and scientists at the forefront of the field, An Introduction to Toxicogenomics provides a comprehensive overview of this new discipline. With a focus on toxicology, it introduces the basic principles of microarray/oligonucleotide array-based genomic analysis and explains how it fits into the field of biomedical research. These discussions provide an overview to the actual mechanics of the analyses themselves and offer insights on handling and quality control. Then the book features an important section on the basics of data analysis and clustering methods such as genetic algorithms. Finally, it covers the application of expression profiling in the field of toxicology and addresses the two fundamental types of analysis in detail, with sections dedicated to both mechanistic and predictive studies.

Although toxicogenomics promises fast, efficient techniques and information-rich data, much of its potential remains untapped. An Introduction to Toxicogenomics consolidates the concepts underlying the field to provide a solid foundation from which to begin your research endeavors.

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

Bringing together the recent and relevant contributions of over 125 scientists from industry, government, and academia in North America and Western Europe, Alternative Toxicological Methods explores the development and validation of replacement, reduction, and refinement alternatives (the 3Rs) to animal testing. Internationally recognized scientists present what has been accomplished thus far in developing acceptable alternatives to traditional animal toxicological assessment and provide potentially new initiatives.

In over 40 chapters, the book addresses 7 themes, beginning with the validation and regulatory acceptance of alternatives in the US, the UK, and Western Europe. Then the book covers methods based on the mechanisms of eye irritation at the ocular surface, dermal toxicity testing, and assessing neurotoxicity. It also includes a case study in the use of alternatives to determine the mechanism of sulfur mustard action and discusses the role of transgenics and toxicokinetics in the development of alternative toxicity tests. Finally the book presents recent innovations in alternatives, including the use of archival data, and in silico techniques.

Focusing on the science and not the politics, Alternative Toxicological Methods concisely discusses the application of state-of-the-art methods and explores cutting-edge research related to developing and validating alternatives to animal testing. This book will benefit toxicologists, cosmetic chemists, pharmacologists, experimental biologists, dermatologists, ophthalmologists, and regulatory officers in their quest for applying the 3Rs to the use of animals in toxicological testing of drug candidates, chemicals, and cosmetics.

Read this book in order to learn:
· Why medicines often fail to produce the desired result and how such failures can be avoided
· How to think about drug product safety and effectiveness
· How the main participants in a medications use system can improve outcomes and how professional and personal values, attitudes, and ethical reasoning fit into drug therapy
· What a properly designed and managed medications use system would look like - specific components, how the components fit together into a system, and how the system can be maintained and improved
· Ways to evaluate medications use systems, how to recognize ineffective systems operations, how to identify missing system components and how to correct them
· How the environment of medications use affects systems operations and patient outcomes, and why standards must change to improve drug safety and effectiveness

Drug-related illnesses and complications cost the health care system billions of dollars each year. Medical errors account for approximately 100,000 deaths each year, and drugs are the most common cause of medical errors in hospitals. Synthesizing research studies from seven nations, Preventing Medication Errors and Improving Drug Therapy Outcomes: A Management Systems Approach explores medications use from a social perspective. It identifies and describes the preventable adverse outcomes of drug therapy, discusses the safety, cost-effectiveness, and quality of medications use from a management systems perspective, and proposes systematic solutions.

The gastrointestinal tract is the most important of the three major routes of entry (and clearance) of xenobiotics and biologic entities into the bodies of mammals. As such, it is also the major route for administration of pharmaceuticals to humans. Gastrointestinal Toxicology, Second Edition describes the mechanism for entry and clearance of xenobiotics, as well as the barriers, immunologic and metabolic issues, and functions present in the GI tract. Appearing in this volume are also considerations of the microbiome and its actions and influence on the function of the GI tract and on the toxicity and pharmacodynamics of ingested substances (including nutrients, toxins, and therapeutics). These fifteen chapters written by experienced experts in the field address methods to evaluate GI function; specifics of GI function and toxicity assessment in canines and minipigs; classes of compounds with their toxicity; species differences; and the toxicity (and promise) of nanoparticles. Those needing to understand the structure, function, and methods of studying the GI tract will find this volume a singular source of reference.

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.