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Amitava Dasgupta Resolving Erroneous Reports in Toxicology and Therapeutic Drug Monitoring. A Comprehensive Guide


The tools for detecting false positives, false negatives, and interference in interactions when testing and monitoring therapeutic drug use For physicians monitoring a patients progress, efficacy of treatment is often linked to a patients response to medication. Determining whether a patient is taking the prescribed amount, the drug or dosage is effective, or the prescribed medication is interacting with other drugs can be determined through drug testing. Written as a guide for toxicologists, chemists, and health professionals involved in patient care, Resolving Erroneous Reports in Toxicology and Therapeutic Drug Monitoring provides an up-to-date introduction to the tests and methodologies used in a toxicology lab as well as the sources of testing error that can lead to false positives, false negatives, and unreliable conclusions of drug abuse or under use. Covering a host of common therapeutic drugs as well as specific types of interference in immunoassays used in drug testing, the book details a number of possible testing scenarios and problems as well as solutions: False positive results in immunoassays for drugs in abuse testing Interferences in immunoassays used for monitoring anticonvulsants, tricyclic antidepressants, and digoxin False positive alcohol tests using breath analyzers and automated analyzers When a toxicology report is negative in a suspected overdose patient: the world of designer drugs Effects of drug-herb interactions on therapeutic drug monitoring Pharmacogenomics and the general principles of genetic analysis Approaches for eliminating interference/discordant specimen in therapeutic drug monitoring and drugs in abuse testing What to do in case there is no readily available method for testing Complete with easy-to-read tables and flowcharts, this book helps toxicologists, clinical chemists, clinical pathologists, and forensic pathologists develop accurate, unbiased drug monitoring and toxicology reports. Health care professionals involved in patient care, especially of critically ill patients, will find this guide indispensable in making sure lab tests are reliable enough to provide high-quality care. An indispensable handbook to the entire suite of toxicology lab tests, as well as all the possible sources of testing error, Resolving Erroneous Reports in Toxicology and Therapeutic Drug Monitoring offers clear remedies for eliminating and preventing testing error.

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Zhou Honghui Drug-Drug Interactions for Therapeutic Biologics


Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics.

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Sara A. Hurvitz Antibody-Drug Conjugates. Fundamentals, Drug Development, and Clinical Outcomes to Target Cancer


Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells. • Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies • Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging • Includes case studies of ADCs in oncology drug development • Features contributions from highly-regarded experts on the frontlines of ADC research and development

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Dasgupta Amitava Pharmacogenomics in Clinical Therapeutics


Pharmacogenomics is the basis of personalized medicine which will be the medicine of the future. Through both reducing the numbers of adverse drug reactions and improving the use of existing drugs in targeted populations, pharmacogenomics represents a real advance on traditional therapeutic drug monitoring. Pharmacogenomics in Clinical Therapeutics provides an introduction to the principles of pharmacogenomics before addressing the pharmacogenomic aspects of key therapeutic areas such as warfarin therapy, cancer chemotherapy, therapy with immunosuppressants, antiretroviral therapy, and psychoactive drugs. It also includes methods of pharmacogenomic testing and the pharmacogenomic aspects of drug–drug interactions. From a team of expert contributors, Pharmacogenomics in Clinical Therapeutics is a comprehensive overview of the current state of pharmacogenomics in pharmacotherapy for all clinicians, pharmacologists and clinical laboratory professionals. It is also a guide for practicing clinicians and health care professionals to the basic principles of pharmacogenomics, laboratory tests currently available to aid clinicians, and the future promise of this developing field.

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Binghe Wang Evaluation of Drug Candidates for Preclinical Development. Pharmacokinetics, Metabolism, Pharmaceutics, and Toxicology


Emphasizes the integration of major areas of drug discovery and their importance in candidate evaluation It is believed that selecting the «right» drug candidate for development is the key to success. In the last decade, pharmaceutical R&D departments have integrated pharmacokinetics and drug metabolism, pharmaceutics, and toxicology into early drug discovery to improve the assessment of potential drug compounds. Now, Evaluation of Drug Candidates for Preclinical Development provides a complete view and understanding of why absorption-distribution-metabolism-excretion-toxicology (ADMET) plays a pivotal role in drug discovery and development. Encompassing the three major interrelated areas in which optimization and evaluation of drug developability is most critical—pharmacokinetics and drug metabolism, pharmaceutics, and safety assessment—this unique resource encourages integrated thinking in drug discovery. The contributors to this volume: Cover drug transporters, cytochrome P-450 and drug-drug interactions, plasma protein binding, stability, drug formulation, preclinical safety assessment, toxicology, and toxicokinetics Address developability issues that challenge pharma companies, moving beyond isolated experimental results Reveal connections between the key scientific areas that are critical for successful drug discovery and development Inspire forward-thinking strategies and decision-making processes in preclinical evaluation to maximize the potential of drug candidates to progress through development efficiently and meet the increasing demands of the marketplace Evaluation of Drug Candidates for Preclinical Development serves as an introductory reference for those new to the pharmaceutical industry and drug discovery in particular. It is especially well suited for scientists and management teams in small- to mid-sized pharmaceutical companies, as well as academic researchers and graduate students concerned with the practical aspects related to the evaluation of drug developability.

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Saura Sahu C. microRNAs in Toxicology and Medicine


During the past decade it has become evident that microRNAs regulate gene expressions and control many developmental and cellular processes in eukaryotic organisms. Recent studies suggest that microRNAs play an important role in toxicogenomics and are likely to play an important role in a range of human diseases including cancer. microRNAs in Toxicology and Medicine is a comprehensive and authoritative compilation of up-to-date developments in this emerging research area, presented by internationally recognized investigators. It focuses on the role of microRNA in biology and medicine with a special emphasis on toxicology. Divided into six parts, topics covered include: microRNA and toxicology – including environmental toxicants and perturbation of miRNA signaling; microRNA, and Disease States featuring microRNAs in drug-induced liver toxicity, microRNAs and Inflammation the regulatory role of microRNA in mutagenesis, microRNAs and cancer, and the role of microRNAs in tumor progression and therapy, as well as current understanding of microRNAs as therapeutic targets in cancer microRNAs and disease states microRNAs and stem cells microRNAs and genomics microRNAs and epigenomics microRNAs and biomarkers – including body fluid microRNAs as toxicological biomarkers, cell-free microRNAs as biomarkers in human diseases, and circulating microRNAs as biomarkers of drug-induced pancreatitis microRNAs in Toxicology and Medicine is an essential insight into the current trends and future directions of research in this rapidly expanding field for investigators, toxicologists, risk assessors, and regulators in academia, medical settings, industry, and government.

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Yvonne Will Drug Discovery Toxicology. From Target Assessment to Translational Biomarkers


As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

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Saura Sahu C. Toxicology and Epigenetics


Epigenetics is the study of both heritable and non-heritable changes in the regulation of gene activity and expression that occur without an alteration in the DNA sequence. This dynamic and rapidly developing discipline is making its impact across the biomedical sciences, in particular in toxicology where epigenetic differences can mean that different individuals respond differently to the same drug or chemical. Toxicology and Epigenetics reflects the multidimensional character of this emerging area of toxicology, describing cutting-edge molecular technologies to unravel epigenetic changes, the use of in vivo and in vitro models, as well as the potential use of toxicological epigenetics in regulatory environments. An international team of experts consider the interplay between epigenetics and toxicology in a number of areas, including environmental, nutritional, pharmacological, and computational toxicology, nanomaterials, proteomics and metabolomics, and cancer research. Topics covered include: environment, epigenetics and diseases DNA methylation and toxicogenomics chromatin at the intersection of disease and therapy epigenomic actions of environmental arsenicals environment, epigenetics and cardiovascular health toxicology, epigenetics and autoimmunity ocular epigenomics: potential sites of environmental impact in development and disease nuclear RNA silencing and related phenomena in animals epigenomics – impact for drug safety sciences methods of global epigenomic profiling transcriptomics: applications in epigenetic toxicology Toxicology and Epigenetics is an essential insight into the current trends and future directions of research in this rapidly expanding field for investigators, toxicologists, risk assessors and regulators in academia, industry and government.

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Botana Luis M. Therapeutic Targets. Modulation, Inhibition, and Activation


The Latest Applications For Cellmechanism Research in Drug Discovery Designed to connect research on cell mechanisms with the drug discovery process, Therapeutic Targets: Modulation, Inhibition, and Activation introduces readers to a range of new concepts and novel approaches to drug screening and therapeutic drug targeting to help inform future avenues of drug research. Highly topical, this accessible edited volume features chapters contributed by respected experts from around the globe. The book helps postgraduate students and professional scientists working in academia and industry understand the molecular mechanisms of pharmacology, current pharmacological knowledge, and future perspectives in drug discovery, focusing on important biochemical protein targets and drug targeting strategies for specific diseases. Examining the pharmacology of therapeutically undefined targets and their potential applications, it includes chapters on traditional therapeutic targets, including enzymes (phosphodiesterases and proteases), ion channels, and G protein-coupled receptors, as well as more recently identified avenues of exploration, such as lipids, nuclear receptors, gene promoters, and more. Since different diseases require different targeting techniques, the book also includes dedicated chapters on strategies for investigating Alzheimers, diabetes, pain, and inflammation treatments. Concluding with a cross-sectional look at new approaches in drug screening, Therapeutic Targets is an invaluable resource for understanding where the next generation of drugs are likely to emerge.

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Wu-Kuang Yeh Enzyme Technologies. Pluripotent Players in Discovering Therapeutic Agent


Sets the stage for advances in drug discovery using the latest enzyme technology Reviewing new and emerging applications of enzyme technology in drug discovery, this book highlights some of the most promising areas of pharmaceutical and biotechnology research. It covers enzyme assay technology, utilization of enzymology for prodrug design, and the application of enzymes as therapeutic agents. Expert reviews highlight how our latest understanding of enzymology is used to develop new practical applications in drug discovery and design. Filled with case studies, Enzyme Technologies: Pluripotent Players in Discovering Therapeutic Agents enables readers to better understand the diverse functions of enzymes and master specific applications in drug discovery research. In addition to small molecule drug discovery, the book explores new developments in enzymes as therapeutic agents for genetic disorders. Section A, Enzymes – Essential Workhorses in Pharmaceutical Research, offers support in selecting the best enzyme targets for drug discovery, designing enzyme inhibitors for therapeutic agents, and evaluating selective enzyme inhibitors. Section B, Enzymes – Indispensable Tools for Improving Druggability, sets forth the principles alongside real-world examples of exploiting specific properties of enzymes to design successful prodrugs. Section C, Enzymes – Powerful Weapons for Correcting Natures Errors, provides new insights on applying enzymes as therapeutic agents or diagnostic tools to treat genetic disorders. Chapters are contributed by leading experts from around the world. Their contributions are based on a thorough review of the current literature as well as their own research. Reviewing our latest understanding of the nature of enzymes and their role in drug discovery, this book is recommended for researchers in pharmaceuticals and biotechnology as well as for researchers in enzymology, biochemistry, molecular biology, and medicinal chemistry.

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Resolving Erroneous Reports in Toxicology and Therapeutic ...

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The tools for detecting false positives, false negatives, and interference in interactions when testing and monitoring therapeutic drug use For physicians monitoring a patient's progress, efficacy ...

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Resolving Erroneous Reports in Toxicology and Therapeutic ...

Written as a guide for toxicologists, chemists, and health professionals involved in patient care, Resolving Erroneous Reports in Toxicology and Therapeutic Drug Monitoring provides an up-to-date introduction to the tests and methodologies used in a toxicology lab as well as the sources of testing error that can lead to false positives, false negatives, and unreliable conclusions of drug abuse or under use.

Amitava dasgupta resolving erroneous reports in toxicology and therapeutic drug. Resolving Erroneous Reports in Toxicology and Therapeutic ...

Written as a guide for toxicologists, chemists, and health professionals involved in patient care, Resolving Erroneous Reports in Toxicology and Therapeutic Drug Monitoring provides an up-to-date introduction to the tests and methodologies used in a toxicology lab as well as the sources of testing error that can lead to false positives, false negatives, and unreliable conclusions of drug abuse or under use.

Lodola Alberto Pharmaceutical Toxicology in Practice. A Guide to Non-clinical Development


This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional” toxicology in the risk assessment and risk management of pharmaceuticals.

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West Anthony R. Cyclic-Nucleotide Phosphodiesterases in the Central Nervous System. From Biology to Drug Discovery


This book reviews advances in understanding phosphodiesterases within the central nervous system and their therapeutic applications. A range of expert authors from both academia and industry describe these, then focus on the areas of greatest scientific and medical interest to provide more detailed coverage. Therapeutic and drug discovery applications are covered for diseases including Alzheimers, Parkinsons, schizophrenia, erectile dysfunction, and spinal cord injuries. There is also a chapter on drug discovery tools such as in vitro assays and X-ray structures for medicinal chemistry studies.

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Lu Chuang Enzyme Inhibition in Drug Discovery and Development. The Good the Bad


The science and applied approaches of enzyme inhibition in drug discovery and development Offering a unique approach that includes both the pharmacologic and pharmaco-kinetic aspects of enzyme inhibition, Enzyme Inhibition in Drug Discovery and Development examines the scientific concepts and experimental approaches related to enzyme inhibition as applied in drug discovery and drug development. With chapters written by over fifty leading experts in their fields, Enzyme Inhibition in Drug Discovery and Development fosters a cross-fertilization of pharmacology, drug metabolism, pharmacokinetics, and toxicology by understanding the «good» inhibitions—desirable pharmacological effects—and «bad» inhibitions—drug–drug interactions and toxicity. The book discusses: The drug discovery process, including drug discovery strategy, medicinal chemistry, analytical chemistry, drug metabolism, pharmacokinetics, and safety biomarker assessment The manipulations of drug metabolizing enzymes and transporters as well as the negative consequences, such as drug–drug interactions The inhibition of several major drug target pathways, such as the GPCR pathway, the NFkB pathway, and the ion channel pathway Through this focused, single-source reference on the fundamentals of drug discovery and development, researchers in drug metabolism and pharmacokinetics (DMPK) will learn and appreciate target biology in drug discovery; discovery biologists and medicinal chemists will also broaden their understanding of DMPK.

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Casciano Daniel A. Handbook of Nanotoxicology, Nanomedicine and Stem Cell Use in Toxicology


The Handbook of Nanotoxicology, Nanomedicine and Stem Cell Use in Toxicology provides an insight into the current trends and future directions of research in these rapidly developing scientific fields. Written by leading scientists and experts, the Handbook will be of interest to various scientific disciplines including toxicology, medicine, and pharmacology, as well as food, drug, and other regulatory sciences.

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Tiwari Ashutosh Nanomaterials in Drug Delivery, Imaging, and Tissue Engineering


This groundbreaking, multidisciplinary work is one of the first books to cover Nanotheragnostics, the new developmental edge of nanomedicine. Through a collection of authoritative chapters, the book reports on nanoscopic therapeutic systems that incorporate therapeutic agents, molecular targeting, and diagnostic imaging capabilities. An invaluable reference for researchers in materials science, bioengineering, pharmacy, biotechnology, and nanotechnology, this volume features four main parts on biomedical nanomaterials, advanced nanomedicine, nanotheragnostics, and nanoscaffolds technology.

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Buchwald Peter Retrometabolic Drug Design and Targeting


Innovative approach to drug design thats more likely to result in an approvable drug product Retrometabolic drug design incorporates two distinct drug design approaches to obtain soft drugs and chemical delivery systems, respectively. Combining fundamentals with practical step-by-step examples, Retrometabolic Drug Design and Targeting gives readers the tools they need to take full advantage of retrometabolic approaches in order to develop safe and effective targeted drug therapies. The authors, both pioneers in the fields of soft drugs and retrometabolic drug design, offer valuable ideas, approaches, and solutions to a broad range of challenges in drug design, optimization, stability, side effects, and toxicity. Retrometabolic Drug Design and Targeting begins with an introductory chapter that explores new drugs and medical progress as well as the challenges of todays drug discovery. Next, it discusses: Basic concepts of the mechanisms of drug action Drug discovery and development processes Retrometabolic drug design Soft drugs Chemical delivery systems Inside the book, readers will find examples from different pharmacological areas detailing the rationale for each drug design. These examples set forth the relevant pharmacokinetic and pharmacodynamic properties of the new therapeutic agents, comparing these properties to those of other compounds used for the same therapeutic purpose. In addition, the authors review dedicated computer programs that are available to support and streamline retrometabolic drug design efforts. Retrometabolic Drug Design and Targeting is recommended for all drug researchers interested in employing this newly tested and proven approach to developing safe and effective drugs.

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Basil Roufogalis Flavonoid Pharmacokinetics. Methods of Analysis, Preclinical and Clinical Pharmacokinetics, Safety, Toxicology


SETS FORTH A FRAMEWORK FOR THE ANALYSIS AND STUDY OF FLAVONOIDS More and more dietary supplements contain flavonoids. These products are typically viewed as food rather than drug products by regulatory agencies and therefore not subjected to rigorous clinical trials before they are marketed to the general public. As a result, the use of flavonoid-containing supplements presents a potential public health risk. From discovery to therapeutic application, this book is a comprehensive guide to both achiral and chiral flavonoids, enabling researchers to perform essential preclinical and clinical pharmacokinetics studies in order to ensure the efficacy of flavonoids marketed for therapeutic use. Moreover, the book examines the safety and toxicology of flavonoids as well as flavonoid-drug interactions. With contributions from a multidisciplinary team of leading researchers, Flavonoids Pharmacokinetics reviews and synthesizes the most recent research findings and results from preclinical and clinical studies. The book begins with a comprehensive overview of polyphenols and flavonoids. Next, the book covers: Methods of analysis of achiral flavonoids Preclinical pharmacokinetic of flavonoids Toxicology and safety of flavonoids Methods of analysis for chiral flavonoids Clinical pharmacokinetics of flavonoids Flavonoids and drug interactions Throughout the book, the authors provide examples that demonstrate the use of pharmacokinetics concepts during the preclinical and clinical drug development process. Flavonoid Pharmacokinetics is written for pharmaceutical, food, and nutritional scientists and students, offering the tools they need to thoroughly analyze and test flavonoids and flavonoid-containing supplements to ensure their safety and efficacy.

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Saura Sahu C. Stem Cells in Toxicology and Medicine


A comprehensive and authoritative compilation of up-to-date developments in stem cell research and its use in toxicology and medicine Presented by internationally recognized investigators in this exciting field of scientific research Provides an insight into the current trends and future directions of research in this rapidly developing new field A valuable and excellent source of authoritative and up-to-date information for researchers, toxicologists, drug industry, risk assessors and regulators in academia, industry and government

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Gomtsyan Arthur Vanilloid Receptor TRPV1 in Drug Discovery. Targeting Pain and Other Pathological Disorders


Examines the emerging therapeutic role of TRPV1 TRPV1 is considered an integrator of noxious stimuli and therefore may be at a crossroads for pain transmission pathways. Because of its potential for managing multiple pain types, including osteoarthritis, chronic low back pain, neuropathic pain, and cancer pain, some consider it «the holy grail» of pain management. This dedicated reference summarizes available data related to the potential therapeutic utility for TRPV1 ligands. With contributions from many of the worlds leading experts on TRP channels, Vanilloid Receptor TRPV1 in Drug Discovery covers the important TRPV1 target for drugs to treat painful conditions such as inflammation, arthritis, and cancer pain. The book discusses: Recent advances in biology, chemistry, and pharmacology at both the preclinical and clinical stage of the dynamic area of TRPV1 drug discovery research The potential for drugs targeting TRPV1 in painful conditions such as inflammation, arthritis, and cancer The development of analgesic drugs Other applications for TRPV1, including the treatment of respiratory disease and diabetes Featuring data relevant to the therapeutic potential of TRPV1 and the medicinal chemistry involved in designing TRPV1 antagonists, Vanilloid Receptor TRPV1 in Drug Discovery is a key tool for researchers in the pharmaceutical industry and academia involved in pain, ion channels, and analgesic drug development.

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Honghui Zhou ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins. Applications in Drug Discovery Development


With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines • Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan • Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain

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