Search

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy - Includes the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology

Concepts and Models for Drug Permeability Studies: Cell and Tissue Based in Vitro Culture Models, Second Edition, summarizes the most important developments in in vitro models for predicting the permeability of drugs. This book is structured around three different approaches, summarizing the most recent achievements regarding models comprising (i) immortalized cells with an intrinsic ability to grow as monolayers when seeded in permeable supports, (ii) primary cells isolated from living organisms and directly cultured as barrier monolayers, and (iii) tissue-based models constructed with cell lines and extracellular matrix that resembles the tridimensional structure of mucosae and other biological membranes, or animal/patient-derived tissues. Each model is covered in detail, including the protocol of generation and application for specific drugs/drug delivery systems. The equivalence between in vitro cell and tissue models and in vivo conditions is discussed, highlighting how each model may provisionally resemble different drug absorption route. Chapters included in the first edition were updated with relevant data published in recent years, while four new chapters were included to reflect new emerging directions and trends in drug permeability models. Concepts and Models for Drug Permeability Studies: Cell and Tissue Based in Vitro Culture Models, Second Edition, is a critical reference for drug discovery and drug formulation scientists interested in delivery systems intended for the administration of drugs through mucosal routes and other important tissue barriers (e.g. the BBB). Researchers studying mucosal biology can use this book to familiarize themselves and exploit the synergic effect of mucosal delivery systems and biomolecules. - Summarizes the current advances in the use of permeability models in drug transport - Covers the most important buccal, gastric, intestinal, pulmonary, nasal, vaginal, ocular, renal, skin, and blood–brain barrier in vitro models. Includes case studies to facilitate understanding of various concepts in computer-aided applications - Updates in the second edition include organ-on-chip devices, 3D advanced models (multiple layered tissues, organoids, etc.), and multicompartmentalized tissue models

Hayes'Principles and Methods of Toxicology has long been established as a reliable and informative reference for the concepts, methodologies, and assessments integral to toxicology. The new edition contains updated and new chapters with the addition of new authors while maintaining the same high standards that have made this book a benchmark resource in the field. Key Features: The comprehensive yet concise coverage of various aspects of fundamental and applied toxicology makes this book a valuable resource for educators, students, and professionals. Questions provided at the end of each chapter allow readers to test their knowledge and understanding of the material covered. All chapters have been updated and over 60 new authors have been added to reflect the dynamic nature of toxicological sciences New topics in this edition include Safety Assessment of Cosmetics and Personal Care Products, The Importance of the Dose/Rate Response, Novel Approaches and Alternative Models, Epigenetic Toxicology, and an Expanded Glossary. The volume is divided into 4 major sections, addressing fundamental principles of toxicology (Section I.'Principles of Toxicology'), major classes of established chemical hazards (Section II.'Agents'), current methods used for the assessment of various endpoints indicative of chemical toxicity (Section III.'Methods'), as well as toxicology of specific target systems and organs (Section IV.'Organ- and System-Specific Toxicology'). This volume will be a valuable tool for the audience that wishes to broaden their understanding of hazards and mechanisms of toxicity and to stay on top of the emerging methods and concepts of the rapidly advancing field of toxicology and risk assessment.

Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.

This fully revised and expanded volume is an effort to blend the common approaches to pharmacokinetics and toxicokinetics. It integrates the principles held in common by both fields through a logical and systematic approach, which includes mathematical descriptions of physical and physiological processes employed in the approaches to pharmacokinetics and toxicokinetics modeling. It emphasizes general principles and concepts and related, isolated applications and case study observations. The systematic compilation of mathematical concepts and methodologies allows readers to decide on relevant concepts and approaches for their research, scientific or regulatory decisions, or for offering advanced courses/workshops and seminars.Features: Comprehensive handbook on principles and applications of PK/TK appealing to a diverse audience including scientists and students An excellent text fully revised and fully updated for anyone interested in the theoretical and practical pharmacokinetics The systematic compilation of mathematical concepts and methodologies allows readers to decide on relevant concepts and approaches for their research Incorporates research relevant to SDGs and of interest to industrial and regulatory environmental scientists involved in chemical contamination research and regulatory decision making related to soil, water, and ocean Includes sections on applications and case studies

Pulmonary Pharmacology, Volume 98 provides in-depth reviews on the latest progresses about respiratory drug discovery and development. Topics covered in this volume include corticosteroids, monoclonal antibodies, tyrosine kinase inhibitors and phosphodiesterase inhibitors for the treatments of asthma, COPD or pulmonary fibrosis, with perspective on the development of novel therapeutic strategies such as renin-angiotensin system modulators, mitochondrial function modulators, and non-antibacterial macrolides. Part of the volume is devoted to senotherapy for lung ageing in respiratory diseases, and novel pulmonary delivery technologies, including inhaled biologics. - Provides accurate reviews from leading experts on the topic of pulmonary pharmacology - Each chapter of the volume provides consolidated graphical materials for ease of reading for the audience - Provides the latest insights and future perspectives on the drug discovery and development for respiratory diseases

Theoretical and Computational Photochemistry: Fundamentals, Methods, Applications and Synergy with Experimental Approaches provides a comprehensive overview of photoactive systems and photochemical processes. After an introduction to photochemistry, the book discusses the key computational chemistry methods applied to the study of light-induced processes over the past decade, and further outlines recent research topics to which these methods have been applied. By discussing the synergy between experimental and computational data, the book highlights how theoretical studies could facilitate understanding experimental findings. This helpful guide is for both theoretical chemists and experimental photochemistry researchers interested in utilizing computational photochemistry methods for their own work. - Reviews the fundamentals of photochemistry, helping those new to the field in understanding key concepts - Provides detailed guidance and comparison of computational and theoretical methods, highlighting the suitability of each method for different case studies - Outlines current applications to encourage discussion of the synergy between experimental and computational data, and inspiring further application of these methods to other photochemical processes

The field of nanomedicine has risen quickly due to the increasing number of designer-made nanomaterials. These nanomaterials have the potential to manage diseases and change the way medicine is currently studied. However, the increased practice of using nanomaterials has shed light on how many concepts of nanomedicine and nanotoxicity have been overlooked. Nanotoxicology: Toxicity Evaluation of Nanomedicine Applications addresses the existing gaps between nanomedicine and nanotoxicity. This book also brings together up-to-date knowledge on advances toward safe-by-design nanomaterials and existing toxicity challenges. This book delivers a comprehensive coverage in the field with fundamental understanding, serving as a platform to convey essential concepts of nanotoxicology and how these concepts can be employed to develop advanced nanomaterials for a range of biomedical applications. This book is an effort to answer some of the thoughtful nanotoxicological complications and their auspicious probable solutions with new approaches and careful toxicity assessment. Key Features: Reveals novel nanoscale approaches, toxicity assessment, and biomedical applications Includes importance of nanotoxicity concepts in developing smart nanomaterials Highlights unique contributions and'A to Z'aspects on the state-of-the-art from global leaders Offers a complete package to learn fundamentals with recommendations on nanomaterials toxicity and safe-by-design nanomedicines Nanotoxicology: Toxicity Evaluation of Nanomedicine Applications illuminates the high potential of many innovative nanomaterials, ultimately demonstrating them to be promising substitutes for available therapies that can be effectively used in fighting a myriad of biomedical complications. Further, this book reports legal, ethical, safety, and regulatory issues associated with nanomaterials, which have often been neglected, if not overlooked in literature and limiting clinical translation at nanoscale level. It will equip readers with cutting-edge knowledge of promising developments in nanomedicine and nanotoxicology, along with potential future prospects.

This textbook provides a comprehensive overview of the currently used concepts, approaches and technologies in the discovery and development of new treatments for the full spectrum of disorders of the central nervous system. It guides the reader through all essential steps, from finding an innovative idea, to the registration of a new drug.Divided into four sections, the book starts by presenting a broad perspective on current approaches in central nervous system (CNS) drug discovery. The second section addresses the generation of ideas for the identification of targets and novel treatment strategies; covers core functions in early discovery, and provides an example of a novel treatment paradigm: brain stimulation. The third section highlights strategies and technologies in translational CNS drug discovery. In an effort to bridge the gap between discovery and clinical development, it also covers brain imaging, EEG and cognitive testing approaches. The fourth section extensively discusses the clinical phase of drug development, covering the basics of early clinical testing for psychopharmacological drugs. The book's final chapter addresses the registration for newly developed drugs. Written by experts from academia and industry, the book covers important basics and best practices, as well as recent developments in drug discovery. Offering in-depth insights into the world of drug development, it represents essential reading for early researchers who want to prepare for a career in drug discovery in academia or industry.

This book summarizes recent advances in the chemistry, bioactivity, nutrition, and functional aspects of dietary phytochemicals, as well as the health and functional aspects of foods rich in phytochemicals. Consisting of forty-four chapters, it discusses the different chemical types of phytochemicals in our diets and food and presents data collected from animal or human experiments that are directly related to human health. Each chapter covers the chemistry, epidemiological study, bioavailability, bioactivity (animal experiments) function in humans and safety, as well as products on the market. Moreover, the more than 200 figures make it easy to grasp the main findings in each area.

This volume provides an insight into the future strategies for commercial biocatalysis with a focus on sustainable technologies, together with chemoenzymatic and biotechnological approaches to synthesize various types of approved and new active pharmaceutical ingredients (APIs) via proven and latest synthetic routes using single-step biocatalytic or enzyme cascade reactions. Many of these drugs act as enzyme inhibitors, as discussed in a chapter with a variety of examples. The targeted enzymes are involved in diseases such as different cancers, metastatic and infectious diseases, osteoporosis, and cardiovascular disorders. The biocatalysts employed for API synthesis include hydrolytic enzymes, alcohol dehydrogenases, laccases, imine reductases, reductive aminases, peroxygenases, cytochrome P450 enzymes, polyketide synthases, transaminases, and halogenases. Many of them have been improved with respect to their properties by engineering methods. The book discusses the syntheses of drugs, including alkaloids and antibiotics, non-ribosomal peptides, antimalarial and antidiabetic drugs, prenylated xanthones, antioxidants, and many important (chiral) intermediates required for the synthesis of pharmaceuticals.

This volume connects current ideas and concepts about sleep functions and circadian rhythms with the search for novel target-selective sleep-wake therapeutics. To do so, it provides a timely, state-of-the-art overview of sleep-wake mechanisms in health and disease, ongoing developments in drug discovery, and their prospects for the clinical treatment of sleep-disordered patients. It particularly focuses on the concept that sleep and wakefulness mutually affect each other, and the future therapeutic interventions with either sleep- or wake-promoting agents that are expected to not only improve the quality of sleep but also the waking behavior, cognition, mood and other sleep-associated physiological functions.The chapter'Sleep Physiology, Circadian Rhythms, Waking Performance and the Development of Sleep-Wake Therapeutics'available open access under a CC BY 4.0 license at link.springer.com

Published in 1983: Volume 2 deals with critical analyses of various test methodologies of polymeric implants, including their acute and chronic toxicological evaluation.

Translational Medicine in CNS Drug Development, Volume 29, is the first book of its kind to offer a comprehensive overview of the latest developments in translational medicine and biomarker techniques. With extensive coverage on all aspects of biomarkers and personalized medicine, and numerous chapters devoted to the best strategies for developing drugs that target specific disorders, this book presents an essential reference for researchers in neuroscience and pharmacology who need the most up-to-date techniques for the successful development of drugs to treat central nervous system disorders. Despite increases in the number of individuals suffering from CNS-related disorders, the development and approval of drugs for their treatment have been hampered by inefficiencies in advancing compounds from preclinical discovery to the clinic. However, in the past decades, game-changing strides have been made in our understanding of the pathophysiology of CNS disorders and the relationship of drug exposure in plasma and CNS to pharmacodynamic measures in both animals and humans. - Includes comprehensive coverage of biomarker tools and the role of personalized medicine in CNS drug development - Discusses strategies for drug development for a full range of CNS indications, with particular attention to neuropsychiatric and neurocognitive disorders - Includes chapters written by international experts from industry and academia

Published in 1986: The plant Cannabis sativa L. and its numerous preparations have been used as therapeutic agents for millenia. In the present book, the editor has tried to summarize the use in the past, to present an overview of modern research and applications to predict future developments.

This extensive volume began as a short course primarily geared toward toxicologists who want to expand their understanding of toxicologic pathology in order to be better study directors while also proving to be of great interest to other drug development scientists and regulatory reviewers. The overall goal is to help non-pathologists understand, contextualize, and communicate the pathology data and interpretations from the study pathologist in a practical and usable format. Within the book, readers will find an overview of general pathology concepts that include fundamental vocabulary and the basics of pathophysiological processes, along with numerous chapters devoted to pathology in specific organ systems as well as topics such as biomarkers, correlation of clinical pathology endpoints (chemistry and hematology) with microscopic changes, and well-known pathology findings for classes of toxic substances. Authoritative, practical, and comprehensive, Toxicologic Pathology for Non-Pathologists aims to help non-pathologists understand, converse in, and apply a basic understanding of pathology in their day-to-day careers.

This new volume, Nanomedicine for the Treatment of Disease: From Concept to Application, looks at the application of nanomedicines with a particular focus on their use in the treatment of diseases. The chapters in this volume, contributed by eminent scientists, researchers, and nanotechnologists from across the globe, highlight key advancements, challenges, and opportunities in the area of application of nanomedicines for disease treatment. They explore the design and development of therapeutic nanocarriers for targeting drugs for satiating the demands of disease treatment process. The volume explores the use nanomedicines for the diagnosis and treatment of a multitude various diseases and health conditions, including respiratory diseases, neurological disorders, genetic diseases, pulmonary fungal infections, neuroAIDS, cardiovascular disorders, gastric and colonic diseases, skin disorders, cancer, brain tumors, leishmaniasis and other visceral diseases, hypertension, and ocular diseases.

Principles of Animal Extrapolation addresses the conceptual basis for animal extrapolation and provides an abundance of documentation that illustrates how these principles may be applied in the selection of the more appropriate models and in the interpretation of toxicological studies. The book analyzes and documents each specific biological cause of interspecies differences in susceptibility to toxic agents, including differences in absorption, gut flora, tissue distribution, metabolism, mechanisms and efficiencies of repair, and excretion. The problem of the heterogenicity of the human population is addressed through several chapters that assess the availability and prospects of developing predictive animal models for normal humans, as well as selected potential high-risk groups. Other topics presented in this book include the biological basis of regulatory actions involving attempts to extrapolate from exceptionally high exposure levels to realistic values, especially carcinogens; an assessment of genotoxicity tests, their ability to predict carcinogenicity in whole animals, and the manner in which they should be used by regulatory agencies; birth defects; and predicting the risk of human teratogenesis. Principle of Animal Extrapolation is essential for environmental toxicologists. It also provides valuable information to biomedical scientists (especially those involved in drug development and testing) and regulatory personnel in agencies such as the EPA, the OSHA, the NIOSH, and the FDA.

Kucers'The Use of Antibiotics is the definitive, internationally-authored reference, providing everything that the infectious diseases specialist and prescriber needs to know about antimicrobials in this vast and rapidly developing field. The much-expanded Seventh Edition comprises 4800 pages in 3 volumes in order to cover all new and existing therapies, and emerging drugs not yet fully licensed. Concentrating on the treatment of infectious diseases, the content is divided into four sections - antibiotics, anti-fungal drugs, anti-parasitic drugs, and anti-viral drugs - and is highly structured for ease of reference.Each chapter is organized in a consistent format, covering susceptibility, formulations and dosing (adult and pediatric), pharmacokinetics and pharmacodynamics, toxicity, and drug distribution, with detailed discussion regarding clinical uses - a feature unique to this title. Compiled by an expanded team of internationally renowned and respected editors, with expert contributors representing Europe, Africa, Asia, Australia, South America, the US, and Canada, the Seventh Edition adopts a truly global approach. It remains invaluable for anyone using antimicrobial agents in their clinical practice and provides, in a systematic and concise manner, all the information required when prescribing an antimicrobial to treat infection.

Comprehensive Toxicology, Third Edition, Fifteen Volume Set discusses chemical effects on biological systems, with a focus on understanding the mechanisms by which chemicals induce adverse health effects. Organized by organ system, this comprehensive reference work addresses the toxicological effects of chemicals on the immune system, the hematopoietic system, cardiovascular system, respiratory system, hepatic toxicology, renal toxicology, gastrointestinal toxicology, reproductive and endocrine toxicology, neuro and behavioral toxicology, developmental toxicology and carcinogenesis, also including critical sections that cover the general principles of toxicology, cellular and molecular toxicology, biotransformation and toxicology testing and evaluation. Each section is examined in state-of-the-art chapters written by domain experts, providing key information to support the investigations of researchers across the medical, veterinary, food, environment and chemical research industries, and national and international regulatory agencies. Thoroughly revised and expanded to 15 volumes that include the latest advances in research, and uniquely organized by organ system for ease of reference and diagnosis, this new edition is an essential reference for researchers of toxicology. - Organized to cover both the fundamental principles of toxicology and unique aspects of major organ systems - Thoroughly revised to include the latest advances in the toxicological effects of chemicals on the immune system - Features additional coverage throughout and a new volume on toxicology of the hematopoietic system - Presents in-depth, comprehensive coverage from an international author base of domain experts

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

There have been major advancements in the pharmacologic treatment of eye diseases over the past decade. With newly discovered disease targets and novel approaches to deliver therapeutic compounds to the eye, patients are seeing improved outcomes. Not only are there better treatments for diseases where treatments existed, we now have effective therapy for previously untreatable and blinding eye disorders. This volume will cover the pharmacologic treatment of eye diseases from the front of the eye including eyelids, conjunctiva and cornea all the way back to the retina and optic nerve. The first section of the volume reviews general principles of ocular pharmacology, pharmacokinetics, pharmaceutical sciences, and drug delivery. In addition, the volume provides an up to date guide to the pharmacologic approach to the key eye diseases that threaten sight or ocular function.

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more - Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source

Provides both fundamentals and new and emerging applications Advanced Drug Delivery brings readers fully up to date with the state of the science, presenting the basics, formulation strategies, and therapeutic applications of advanced drug delivery. The book demonstrates how core concepts of pharmaceutical sciences, chemistry, and molecular biology can be combined and applied in order to spark novel ideas to design and develop advanced drug delivery systems for the treatment of a broad range of human diseases. Advanced Drug Delivery features contributions from an international team of pharmaceutical scientists. Chapters reflect a thorough review and analysis of the literature as well as the authors'firsthand experience developing drug delivery systems. The book is divided into four parts: Part I, Introduction and Basics of Advanced Drug Delivery, explores physiological barriers, stability, transporters, and biomaterials in drug delivery Part II, Strategies for Advanced Drug Delivery, offers tested and proven strategies for advanced delivery of both small molecules and macromolecules Part III, Translational Research of Advanced Drug Delivery, focuses on regulatory considerations and translational applications of advanced drug delivery systems for the treatment of cardiovascular diseases, cancer, sexually transmitted diseases, ophthalmic diseases, and brain diseases Part IV, Future Applications of Advanced Drug Delivery in Emerging Research Areas, examines stem cell research, cell-based therapeutics, tissue engineering, and molecular imaging Each chapter provides objectives and assessment questions to help readers grasp key concepts and assess their knowledge as they progress through the book. Advanced Drug Delivery is recommended for graduates and upper-level undergraduates in the pharmaceutical sciences who need a solid foundation in the basics. It is also recommended for pharmaceutical professionals who want to take advantage of new and emerging applications in advanced drug delivery systems.

The aim of the book is to provide an in-depth review of our current understanding of the pathogenesis of both asthma and COPD. This volume also discusses the promising new options for pharmacological intervention of these diseases. Each chapter is extensively referenced, generously illustrated with clear diagrams and photographs, and represents a state-of-the-art review of this important area of lung biology.

Today, the basic mood of researchers and clinical investigators, both at the center and on the periphery of interferon studies, is optimistic regarding the future of interferons as therapeutic substances. Many also feel these polypeptides will prove invaluable probes in unraveling certain fundamental biochemical processes which control the life cycle and developmental pattern of many human cells. In contrast, only a year or two ago, this optimism had given way to an attitude almost of disenchantment as public and scientific expectations were raised steeply, then rapidly waned, as it turns out, prematurely. Both the mUltiple actions of interferons (a virtual cascade of biochemical reactions may be induced, as documented herein) and the high visibility of interferon research provided by the millions of dollars invested both by national health agencies and by multinational pharmaceutical companies, contributed to an upsweep in public attention to drug development probably unprecedented in this century. Virtually every oncologist, it would seem, was plagued by requests for the experimental agent, although they already had therapies of more proven value. As recently as 1980, even though interferon had achieved success against certain cancers and certain viral diseases, the variability in clinical results was seemingly ever present and little evidence emerged to suggest interferons could cure advanced diseases. Why then the resurgence of an optimistic mood? There are almost always many elements which contribute to happiness, and this is certainly true of the broad frontier of interferon and its place in biochemical research and treatment.

'I am unaware of any textbook which provides such comprehensive coverage of the field and doubt that this work will be surpassed in the foreseeable future, if ever!'From the foreword by Robert C. Moellering, Jr., M.D, Shields Warren-Mallinckrodt Professor of Medical Research, Harvard Medical School, USA Kucers'The Use of Antibiotics is the leading major reference work in this vast andrapidly developing field. More than doubled in length compared to the fifth edition, thesixth edition comprises 3000 pages over 2-volumes in order to cover all new and existing therapies, and emerging drugs not yet fully licensed. Concentrating on the treatment of infectious diseases, the content is divided into 4 sections: antibiotics, anti-fungal drugs, anti-parasitic drugs and anti-viral drugs, and is highly structured for ease of reference.Within each section, each chapter is structured to cover susceptibility, formulations and dosing (adult and paediatric), pharmacokinetics and pharmacodynamics, toxicity and drug distribution, detailed discussion regarding clinical uses, a feature unique to this title.Compiled by an expanded team of internationally renowned and respected editors, witha vast number of contributors spanning Europe, Africa, Asia, Australia, South America,the US and Canada, the sixth edition adopts a truly global approach. It will remaininvaluable for anyone using antimicrobial agents in their clinical practice and provides in a systematic and concise manner all the information required when treating infectionsrequiring antimicrobial therapy.Kucers'The Use of Antibiotics is available free to purchasers of the books as an electronic version on line or on your desktop: It provides access to the entire 2-volume print material It is fully searchable, so you can find the relevant information you need quickly Live references are linked to PubMed referring you to the latest journal material Customise the contents - you can highlight sections and make notes Comments can be shared with colleagues/tutors for discussion, teaching and learning The text can also be reflowed for ease of reading Text and illustrations copied will be automatically referenced to Kucers'The Use of Antibiotics

Roots of the theory and practice of ocular pharmacology may be traced to the ancient Mesopotamian code of Hammurabi and then to several papyri reflecting the clinical interests of the Egyptians. The evolution of its art and science was irregularly paced until the nineteenth century when Kohler, in 1884, proved the anesthetic effect of cocaine on the cornea, and when Fraser, Laquer, Schmiedeberg, Meyer, and others studied the pharmacology of the autonomic nervous system by way of observations of the pupil. Advances in the past few decades have been nothing short of explosive. How can the student, physician, or basic research scientist stay in touch with these electrifying studies? To help with the answer to this question, the authors set as their goal the development of increased understanding so that the student, research scientist, and ophthalmologist can cope with the latest discoveries. The authors want to narrow what appears to be an ever-increasing gap between basic science and ophthalmology. The basic aspects of pharmacology have been presented in light of the natural physiology. In this regard, while distinctions among endogenous mechanisms, drug effects, and the pathogenesis of disease are to be separately recognized, appreciation must be given to the concept that both the desirable and unwanted manifestations or functions caused by either disease or drugs must very often represent a quantitative change in normal metabolic pathways.

Henipaviruses form a new genus of emerging paramyxoviruses that are the deadliest human pathogens within the Paramyxoviridae family. This volume deals with the many facets of henipavirus biology, and covers our current understanding regarding the ecology, molecular virology, and pathogenesis of henipavirus infections. It is an international effort written by a multidisciplinary panel of experts at the front lines of research into this lethal emerging group of paramyxoviruses. The first section introduces the epidemiology and ecology of Nipah and Hendra viruses in their respective endemic areas, including a first-hand account of the discovery of Nipah virus during its initial outbreak in Malaysia; the next section documents the molecular virology of henipaviruses, and the substantial advances made towards understanding the unique features of henipavirus entry and tropism; and this is followed by accounts of the clinical and pathologic features of henipavirus infectionsin their human and naturally infected animal hosts. The next sections on pathogenesis provide a comprehensive reference on how henipaviruses counteract the innate immune system, and the relevant pathogenic features in animal challenge models developed to test potential therapeutic strategies. The final sections describe our current and future capabilities for diagnosis and control, including an account of potentially effective immunization strategies that are currently being tested. This book will not only serve as a useful reference for the henipavirus field; it will be useful to basic and animal virologists, ecologists, epidemiologists, physicians, and others interested in emerging infectious viral diseases, as it showcases the multidisciplinary efforts required to understand the genesis, spread and hopefully, control, of a group of lethal emerging zoonotic pathogens.

This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including small molecule, protein, and nucleic acid drugs. Specific topics covered in this book include:Solution, suspension, gel, nanoparticle, microparticle, and implant dosage formsRefillable and microneedle devicesIntravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of deliveryPhysical methods including iontophoresis for drug deliveryRational selection of routes of administration and delivery systemsNoninvasive and continuous drug monitoring Regulatory path to drug product developmentClinical endpoints for drug product developmentEmerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devicesIntravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of deliveryPhysical methods including iontophoresis for drug deliveryRational selection of routesof administration and delivery systemsNoninvasive and continuous drug monitoring Regulatory path to drug product developmentClinical endpoints for drug product developmentEmerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devicesIntravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of deliveryPhysical methods including iontophoresis for drug deliveryRational selection of routes of administration and delivery systemsNoninvasive and continuous drug monitoring Regulatory path to drug product developmentClinical endpoints for drug product developmentEmerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of theeye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering.

'I am unaware of any textbook which provides such comprehensive coverage of the field and doubt that this work will be surpassed in the foreseeable future, if ever!'From the foreword by Robert C. Moellering, Jr., M.D, Shields Warren-Mallinckrodt Professor of Medical Research, Harvard Medical School, USA Kucers'The Use of Antibiotics is the leading major reference work in this vast andrapidly developing field. More than doubled in length compared to the fifth edition, thesixth edition comprises 3000 pages over 2-volumes in order to cover all new and existing therapies, and emerging drugs not yet fully licensed. Concentrating on the treatment of infectious diseases, the content is divided into 4 sections: antibiotics, anti-fungal drugs, anti-parasitic drugs and anti-viral drugs, and is highly structured for ease of reference.Within each section, each chapter is structured to cover susceptibility, formulations and dosing (adult and paediatric), pharmacokinetics and pharmacodynamics, toxicity and drug distribution, detailed discussion regarding clinical uses, a feature unique to this title.Compiled by an expanded team of internationally renowned and respected editors, witha vast number of contributors spanning Europe, Africa, Asia, Australia, South America,the US and Canada, the sixth edition adopts a truly global approach. It will remaininvaluable for anyone using antimicrobial agents in their clinical practice and provides in a systematic and concise manner all the information required when treating infectionsrequiring antimicrobial therapy.Kucers'The Use of Antibiotics is available free to purchasers of the books as an electronic version on line or on your desktop: It provides access to the entire 2-volume print material It is fully searchable, so you can find the relevant information you need quickly Live references are linked to PubMed referring you to the latest journal material Customise the contents - you can highlight sections and make notes Comments can be shared with colleagues/tutors for discussion, teaching and learning The text can also be reflowed for ease of reading Text and illustrations copied will be automatically referenced to Kucers'The Use of Antibiotics

This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current

Volume 2 addresses the applications and approaches in advanced drug delivery systems, including transdermal, pulmonary, and ocular routes. In addition, this text discusses the impact of the shift to personalized medicines in the fields of pharmaceutical biotechnology, pharmacogenomics, and nanotechnology.Volume 2 investigates: sustained- and contr

Transforming Growth Factor-jl in Cancer Therapy, Volume I: Basicand Clinical Biology The present volume brings together a wealth of information that is fundamental to understanding the roleofTGF-~ in the pathogenesis, prevention, and treatment of cancer. It is not even 25 years sinceTGF-~ was first isolated and characterized as a dimeric pep­ tide from both human and bovine sources (1-3), but the entire fieldofTGF-~ research has grown and expanded so that it is now a central theme in all of cell biology. There is almost no tissue or organ in the mammalian body in whichTGF-~ does not playa central role in embryonic differentiation or in adult function, and furthermore, malfunction of the normal physiologyofTGF-~can have disastrous consequences in almost all ofthese sites. Therefore, the present comprehensive review of so many aspects ofTGF-~ function is a most welcome attempt to bring together a huge body of experimental data that is of the utmost importance in the field of oncology.

Providing a significant cross-fertilization of ideas across several disciplines, Enhancement in Drug Delivery offers a unique comprehensive review of both theoretical and practical aspects of enhancement agents and techniques used for problematic administration routes. It presents an integrated evaluation of absorption enhancers and modes fo

Founded on the paradox that all things are poisons and the difference between poison and remedy is quantity, the determination of safe dosage forms the base and focus of modern toxicology. In order to make a sound determination there must be a working knowledge of the biologic mechanisms involved and of the methods employed to define these mechanis

Platelets, Second Edition is the definitive current source of state-of-the-art knowledge about platelets and covers the entire field of platelet biology, pathophysiology, and clinical medicine. Recently there has been a rapid expansion of knowledge in both basic biology and the clinical approach to platelet-related diseases including thrombosis and hemorrhage. Novel platelet function tests, drugs, blood bank storage methods, and gene therapies have been incorporated into patient care or are in development. This book draws all this information into a single, comprehensive and authoritative resource. - First edition won Best Book in Medical Science Award from the Association of American Publishers - Contains fourteen new chapters on topics such as platelet genomics and proteomics, inhibition of platelet function by the endothelium, clinical tests of platelet function, real time in vivo imaging of platelets, and inherited thrombocytopenias - A comprehensive full color reference comprising over 70 chapters, 1400 pages, and 16,000 references

Nanoparticles, products of nanotechnology, are of increasing interest to the pharmaceutical community. They can increase drug solubility, enhance bioavailability, allow tissue targeting, offer decreased side-effects, and improve therapeutic efficacy. Presenting the most pertinent and practical issues in the manufacturing and biological application

From the emergence of clinical sleep medicine marked by the establishment of the harbinger Stanford Sleep Disorders Clinic in the mid 1970s, offspring sleep dis- ders clinics and centers have grown exponentially with the recognition of the unmet diagnostic and treatment needs of the reservoir of patients suffering from sy- toms of what are now recognized and classi?ed as the nosology of human sleep disorders. Important in the growing armamentarium of treatment options for the sleep practitioner are both traditional and newer pharmacological agents, including over-the-counter, non-traditional, and prescription types, that are all used to treat, sometimes adjunctively, most clinically recognized sleep disorders. Although there are numerous academic treatises and reviews dealing with in- vidual treatment alternatives for the diversity of recognized sleep disorders, no one comprehensive resource, extant, has dealt with pharmacological treatment options and strategies for the major human sleep disorders associated with a panoply of symptomatic conditions. The present volume and its series of chapters individually focusing on a range of human conditions, from pediatric sleep disorders to sle- relateddisordersofindividualssufferingfromAlzheimer'sdementia,uniquelycover the wide range of human medical conditions amenable to thoughtfully sleep-related applied drug therapy. The Editors have brought together a superb group of internationally respected sleep clinicians, and researchers, that provide state-of-the-art analysis of the current basic and clinical perspective regarding the most common sleep disorders that are amenable to pharmacological treatment. In each chapter the authors outline a th- oughhistoricalbackgroundoftheparticulardisorderandreviewthebasicpre-clinicalstudies leading to current treatment options.

The Process of New Drug Discovery and Development, Second Edition presents a practical methodology and up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. This new addition updates the scientific advances in new drug discovery and development for areas

Written by a panel of experts, this book covers every stage of drug development, from candidate drug selection to commercial formulation. It provides practical reference and pragmatic guide on what studies need to be undertaken, for what reasons, and at what key stages of the drug development process. Going beyond coverage of preformulation, the bo

First published in 1943, Vitamins and Hormones is the longest-running serial published by Academic Press. In the early days of the Serial, the subjects of vitamins and hormones were quite distinct. The Editorial Board now reflects expertise in the field of hormone action, vitamin action, X-ray crystal structure, physiology, and enzyme mechanisms. Under the capable and qualified editorial leadership of Dr. Gerald Litwack, Vitamins and Hormones continues to publish cutting-edge reviews of interest to endocrinologists, biochemists, nutritionists, pharmacologists, cell biologists, and molecular biologists. Others interested in the structure and function of biologically active molecules like hormones and vitamins will, as always, turn to this series for comprehensive reviews by leading contributors to this and related disciplines.•First published in 1943, Vitamins and Hormones is AP's longest running serial•Each volume contains cutting edge reviews by leading contributors

The second edition of this text assembles significant ophthalmic advances and encompasses breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery.

Over the past ten years several sophisticated in vitro test systems based on epithelial cell cultures have been introduced in the field of drug delivery. These models have been found to be very useful in characterizing the permeability of drugs across epithelial tissues, and in studying formulations or carrier systems for improved drug delivery and

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

As the first detailed overview of the subject, Tight Junctions brought together diverse perspectives from leading investigators to provide a multidisciplinary overview of the field. Since its publication in 1992, there has been an explosion of information about tight junctions, particularly in the area of molecular structure, cell and molecular bio