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Toshihisa Ishikawa Pharmacogenomics of Human Drug Transporters. Clinical Impacts


Sets the foundation for safer, more effective drug therapies With this book as their guide, readers will discover how to apply our current understanding of the pharmacogenomics of drug transporters to advance their own drug discovery and development efforts. In particular, the book explains how new findings in the field now enable researchers to more accurately predict drug interactions and adverse drug reactions. Moreover, it sets the foundation for the development of drug therapies that are tailored to an individual patients genetics. Pharmacogenomics of Human Drug Transporters serves as a comprehensive guide to how transporters regulate the absorption, distribution, and elimination of drugs in the body as well as how an individuals genome affects those processes. The books eighteen chapters have been authored by a team of leading pioneers in the field. Based on their own laboratory and clinical experience as well as a thorough review of the literature, these authors explore all facets of drug transporter pharmacogenomics, including: Individual drug transporters and transporter families and their clinical significance Principles of altered drug transport in drug–drug interactions, pharmacotherapy, and personalized medicine Emerging new technologies for rapid detection of genetic polymorphisms Clinical aspects of genetic polymorphisms in major drug transporter genes Future research directions of drug transporter pharmacogenomics and the prospect of individualized medicine Pharmacogenomics of Human Drug Transporters opens the door to new drug discovery and development breakthroughs leading to safer and more effective customized drug therapies.The book is recommended for pharmaceutical scientists, biochemists, pharmacologists, clinicians, and genetics and genomics researchers.

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Guofeng You Drug Transporters. Molecular Characterization and Role in Disposition


This new edition overviews drug transporters and presents the principles of drug transport and associated techniques, featuring new chapters on multidrug and toxin extrusion proteins, placental transport, in silico approaches in drug discovery, and regulatory guidance for drug transport studies in drug development. • Describes drug transporter families, mechanisms, and clinical implications along with experimental methods for studying and characterizing drug transporters • Includes new chapters on multidrug and toxin extrusion proteins, placental transport and in silico approaches in drug discovery • Has a new chapter covering regulatory guidance for the evaluation of drug transport in drug development with global criteria used for drug transporters in clinical trials • Arranges material to go from fundamental mechanisms to clinical outcomes, making the book useful for novice and expert readers

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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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Gerd Folkers Transporters as Drug Targets


As opposed to other books on the topic, this volume is unique in also covering emerging transporter targets. Following a general introduction to the importance of targeting transporter proteins with drugs, the book systematically presents individual transporter classes and explains their pharmacology and physiology. The text covers all transporter families with known or suspected importance as drug targets, including neurotransmitter transporters, ABC transporters, glucose transporters and organic ion transporters. The final part discusses recent advances in structural studies of transport proteins, assay methods for transport activity, and the systems biology of transporters and their regulation. With its focus on drug development issues, this authoritative overview is required reading for researchers in industry and academia targeting transport proteins for the treatment of disease.

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Jacques Robert ABC Transporters and Multidrug Resistance


A comprehensive review of the most current scientific research on ABC transporters and multidrug resistance ATP-binding cassette transporter genes (ABC transporters) are known to play a crucial role in the development of multidrug resistance (MDR). MDR is the ability of pathologic cells, such as tumors, to withstand chemicals designed to target and destroy such cells. In MDR, patients who are on medication eventually develop resistance to not only the drug they are taking, but to several different types of drugs. ABC Transporters and Multidrug Resistance offers an essential resource for pharmaceutical researchers who are working to discover drugs to counteract multidrug resistance in diseases such as cancer. In one comprehensive volume, this book contains a collection of the most current knowledge on the involvement of ABC transporters in drug transport and resistance. This comprehensive volume provides an overview on the description of the structure, the genome, normal tissue expression, physiological aspect, and mechanism of action of the ABC protein. The expert contributors explore the expression, detection, and implications of ABC proteins in hematological malignancies and solid tumors and ABC proteins and pathogenic microorganisms. This volume also explains MDR modulation through inhibition of ABC transporters and the design of inhibitors and mechanism of action. In addition, the book offers essential information on the biological and clinical aspect of multidrug resistance.

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John Dickenson Molecular Pharmacology. From DNA to Drug Discovery


This textbook provides a fresh, comprehensive and accessible introduction to the rapidly expanding field of molecular pharmacology. Adopting a drug target-based, rather than the traditional organ/system based, approach this innovative guide reflects the current advances and research trend towards molecular based drug design, derived from a detailed understanding of chemical responses in the body. Drugs are then tailored to fit a treatment profile, rather than the traditional method of ‘trial and error’ drug discovery which focuses on testing chemicals on animals or cell cultures and matching their effects to treatments. Providing an invaluable resource for advanced under-graduate and MSc/PhD students, new researchers to the field and practitioners for continuing professional development, Molecular Pharmacology explores; recent advances and developments in the four major human drug target families (G-protein coupled receptors, ion channels, nuclear receptors and transporters), cloning of drug targets, transgenic animal technology, gene therapy, pharmacogenomics and looks at the role of calcium in the cell. Current – focuses on cutting edge techniques and approaches, including new methods to quantify biological activities in different systems and ways to interpret and understand pharmacological data. Cutting Edge – highlights advances in pharmacogenomics and explores how an individual’s genetic makeup influences their response to therapeutic drugs and the potential for harmful side effects. Applied – includes numerous, real-world examples and a detailed case-study based chapter which looks at current and possible future treatment strategies for cystic fibrosis. This case study considers the relative merits of both drug therapy for specific classes of mutation and gene therapy to correct the underlying defect. Accessible – contains a comprehensive glossary, suggestions for further reading at the end of each chapter and an associated website that provides a complete set of figures from within the book. A companion website with additional resources is available at www.wiley.com/go/dickenson/dnamolecular

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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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Li Chun Drug Delivery Applications of Noninvasive Imaging. Validation from Biodistribution to Sites Action


Cost-effective strategies for designing novel drug delivery systems that target a broad range of disease conditions In vivo imaging has become an important tool for the development of new drug delivery systems, shedding new light on the pharmacokinetics, biodistribution, bioavailability, local concentration, and clearance of drug substances for the treatment of human disease, most notably cancer. Written by a team of international experts, this book examines the use of quantitative imaging techniques in designing and evaluating novel drug delivery systems and applications. Drug Delivery Applications of Noninvasive Imaging offers a full arsenal of tested and proven methods, practices and guidance, enabling readers to overcome the many challenges in creating successful new drug delivery systems. The book begins with an introduction to molecular imaging. Next, it covers: In vivo imaging techniques and quantitative analysis Imaging drugs and drug carriers at the site of action, including low-molecular weight radiopharmaceuticals, peptides and proteins, siRNA, cells, and nanoparticles Applications of imaging techniques in administration routes other than intravenous injection, such as pulmonary and oral delivery Translational research leading to clinical applications Imaging drug delivery in large animal models Clinical applications of imaging techniques to guide drug development and drug delivery Chapters are based on a thorough review of the current literature as well as the authors firsthand experience working with imaging techniques for the development of novel drug delivery systems. Presenting state-of-the-technology applications of imaging in preclinical and clinical evaluation of drug delivery systems, Drug Delivery Applications of Noninvasive Imaging offers cost-effective strategies to pharmaceutical researchers and students for developing drug delivery systems that accurately target a broad range of disease conditions.

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Henry Riordan Critical Pathways to Success in CNS Drug Development


Covering the latest advances in CNS drug development, this book will guide all those involved in pre-clinical to early clinical trials. The authors describe how recent innovations can accelerate the development of novel CNS compounds, improve early detection of efficacy and toxicity signals, and increase the safety of later-stage clinical trials. The current crisis in the drug development industry is critically reviewed, as well as the steps needed to correct the problems, including new government-backed regulations and industry-based innovations designed to accelerate CNS drug development in the future. Animal-based models of major CNS disorders are described in detail, and the ability of the latest in vitro and computer-based models to simulate CNS disease states and predict drug efficacy and side-effects are examined. Particular attention is given to the growing use of biomarkers and how they can be used effectively in early human trials as signals of potential drug efficacy, as well as the increasingly important role of imaging studies to guide dose selection. Cognitive assessments that can be useful indicators of effect in patient populations are also discussed. Written by a team of clinical scientists involved in CNS drug trials for over 20 years, and based on a wealth of drug development and clinical trial experience, Critical Pathways to Success in CNS Drug Developmentis full of practical advice for successfully designing and executing CNS drug trials, avoiding potential pitfalls, and complying with government regulations

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Mitchell Cayen N. Early Drug Development. Strategies and Routes to First-in-Human Trials


The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

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Francesco Clementi General and Molecular Pharmacology. Principles of Drug Action


With a focus on functional relationships between drugs and their targets, this book covers basic and general pharmacology, from a cellular and molecular perspective, with particular attention to the mechanisms of drug action – the fundamental basis for proper clinical use- without neglecting clinical application, toxicology and pharmacokinetics. • Covers cell and molecular pharmacology, bringing together current research on regulation of drug targets, at a level appropriate for advanced undergrad and graduate students • Discusses the relevance of pharmacokinetics and drug development for the clinical application of drugs • Presents material from the perspective of drug targets and interaction, the theoretical basis of drug action analysis, and drug properties • Focuses on structure-function relationships of drug targets – informing about their biochemical and physiologic functions and experimental and clinical pathways for drug discovery and development • Has a companion website that offers a host of resources: short additional chapters about methodology, topics at the forefront of research, all figures and tables from the book, and Power Point slides

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Moziah Ali The Transporters of God


Книга "The Transporters of God".

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Souzan Yanni B. Translational ADMET for Drug Therapy. Principles, Methods, and Pharmaceutical Applications


Serving as a practical handbook about ADMET for drug therapy, this book presents effective technologies, methods, applications, data interpretation, and decision-making tactics for pharmaceutical and preclinical scientists. Chapters cover case studies and in vivo, in vitro, and computational tools for drug discovery and development, with new translational approaches to clinical drug investigations in various human populations. Illustrates ADME properties, from bedside to bench and bench to bedside, for the design of safe and effective medicine in human populations Provides examples that demonstrate the integration of in vitro, in vivo, and in silico data to address human PKPD and TKTD and help determine the proper therapeutic dosage Presents successful tools for evaluating drugs and covers current translational ADMET with regulatory guidelines Offers a hands-on manual for researchers and scientists to design and execute in vitro, in silico, preclinical, and clinical studies Includes discussion of IND / NDA filing and drug labeling to support drug registration and approval

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Vera Mihajlovic-Madzarevic Clinical Trials Audit Preparation. A Guide for Good Practice (GCP) Inspections


A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development

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Toshihisa Ishikawa | Ph.D., Professor | RIKEN, Wako ...

Toshihisa Ishikawa Time courses of the SmartAmp reaction during detection of various copy numbers of cDNA encoding the target sequence in the HA segment of the 2009 pdm influenza A(H1N1) virus.

Pharmacogenomics of Human Drug Transporters: Clinical ...

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Pharmacogenomics of Human Drug Transporters

Pharmacogenomics of Human Drug Transporters: Clinical Impacts by Toshihisa Ishikawa. Read online, or download in secure PDF or secure ePub format

Recent Advances in Pharmacogenomic Technology for ...

12 Recent Advances in Pharmacogenomic Technology for Personalized Medicine Toshihisa Ishikawa and Yoshihide Hayashizaki Omics Science Canter, RIKEN Yokohama Institute,

Toshihisa Ishikawa & Richard B. Kim: Pharmacogenomics of ...

Sets the foundation for safer, more effective drugtherapies With this book as their guide, readers will discover how toapply our current understanding of the pharmacogenomics of drugtransporters ...

Ishikawa, J Pharmacogenom Pharmacoproteomics 2012, 3:2 ...

Toshihisa Ishikawa* RIKEN Omics Science Center, 1-7-22 Suehiro-cho, Tsurumi-ku, Yokohama 230-0045, Japan *Corresponding author: Toshihisa Ishikawa, RIKEN Omics Science Center, 1-7-22

Wiley: Pharmacogenomics of Human Drug Transporters ...

With this book as their guide, readers will discover how to apply our current understanding of the pharmacogenomics of drug transporters to advance their own drug discovery and development efforts. In particular, the book explains how new findings in the field now enable researchers to more accurately predict drug interactions and adverse drug reactions. Moreover, it sets the foundation for the development of drug therapies that are tailored to an individual patient's genetics.

Pharmacogenomics of Human Drug Transporters (eBook, PDF ...

Sets the foundation for safer, more effective drugtherapies With this book as their guide, readers will discover how toapply our current understanding of the pharmacogenomics of drugtransporters to advance their own drug discovery and developmentefforts.

Toshihisa Ishikawa | Longdom Publishing SL

Ishikawa is a Member of the International Nomenclature Committee for Human ABC Transporter Genes. Most recently he was one of the Steering Committee Members to organize the FDA Critical Path Transporter Workshop held in Bethesda, MD, USA in October 2 and 3, 2008.

Pharmacogenomics of Human Drug Transporters: Clinical ...

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eBook: Pharmacogenomics of Human Drug Transporters von ...

Pharmacogenomics of Human Drug Transporters von Toshihisa Ishikawa, Richard B. Kim, Jörg König (ISBN 978-1-118-35325-7) online kaufen | Sofort-Download - lehmanns.de

Pharmacogenomics of Human Drug Transporters | Wiley Online ...

Pharmacogenomics of Human Drug Transporters opens the door to new drug discovery and development breakthroughs leading to safer and more effective customized drug therapies.The book is recommended for pharmaceutical scientists, biochemists, pharmacologists, clinicians, and genetics and genomics researchers.

Pharmacogenomics of Human Drug Transporters Buch ...

Autoren-Porträt von Toshihisa Ishikawa, Richard B. Kim, Jörg König TOSHIHISA ISHIKAWA, PhD, is Senior Scientist at RIKEN Yokohama Institute and Professor of Biochemistry, Molecular Biology, and Pharmacogenomics at Yokohama City University's Graduate School of Medicine.

Toshihisa ishikawa pharmacogenomics of human drug transporters clinical impacts. Toshihisa Ishikawa | Ph.D., Professor | RIKEN, Wako ...

Toshihisa Ishikawa Time courses of the SmartAmp reaction during detection of various copy numbers of cDNA encoding the target sequence in the HA segment of the 2009 pdm influenza A(H1N1) virus.

Toshihisa ishikawa pharmacogenomics of human drug transporters clinical impacts. Pharmacogenomics of Human Drug Transporters | Wiley Online ...

Pharmacogenomics of Human Drug Transporters opens the door to new drug discovery and development breakthroughs leading to safer and more effective customized drug therapies.The book is recommended for pharmaceutical scientists, biochemists, pharmacologists, clinicians, and genetics and genomics researchers.

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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Mike Lee S. Oral Bioavailability Assessment. Basics and Strategies for Drug Discovery Development


Specifically geared to personnel in the pharmaceutical and biotechnology industries, this book describes the basics and challenges of oral bioavailability – one of the most significant hurdles in drug discovery and development. • Describes approaches to assess pharmacokinetics and how drug efflux and uptake transporters impact oral bioavailability • Helps readers reduce the failure rate of drug candidates when transitioning from the bench to the clinic during development • Explains how preclinical animal models – used in preclinical testing – and in vitro tools translate to humans, which is an underappreciated and complicated area of drug development • Includes chapters about pharmacokinetic modelling, the Biopharmaceutics Drug Disposition Classification System (BDDCS), and the Extended Clearance Classification System (ECCS) • Has tutorials for applying strategies to medicinal chemistry practices of drug discovery/development

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Kun Cheng Advanced Drug Delivery


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.

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Elizabeth Kwong Oral Formulation Roadmap from Early Drug Discovery to Development


Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing

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Sherrel Howard Drugs of Abuse. Pharmacology and Molecular Mechanisms


Drug abuse has been, and continues to be, a global societal issue with diverse sets of impacts. Drugs of Abuse: Pharmacology and Molecular Mechanisms introduces the basic principles of pharmacology and neuroscience of drug abuse. Understanding the chemistry of commonly abused drugs and their impact on brain function will provide students and researchers with a more profound understanding of the molecular basis of drug abuse and addiction. Drugs of Abuse: Pharmacology and Molecular Mechanisms opens with a brief history of drug use and abuse. Subsequent sections look at specific families of drugs, including stimulants, depressants, and hallucinogens among others, and explore how their chemical make-up interacts with brain function. The final chapter provides a brief overview of clinical substance abuse treatment. Providing a concise, accessible introductory overview of the topic, Drugs of Abuse: Pharmacology and Molecular Mechanisms will be a valuable resource for students, researchers, and others interested in how drugs interact with the brain. Introduces readers to the basic principles of neuroscience and pharmacology as related to drug use and abuse. Explores how the chemical make-up of drugs interact with the brain and can lead to addiction Includes coverage of a wide array of commonly abused families of drugs, including stimulants, depressants, hallucinogens, and others. Provides an essential introduction to the chemical and molecular underpinnings of drug use and abuse

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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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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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Pharmacoepidemiology


Not intended as a textbook of adverse drug reactions but rather as a way to elucidate the methods of investigating adverse drug reactions as well as other questions of drug effects. Section one gives an introduction to the field and presents basic scientific principles of clinical epidemiology. In this edition a chapter has been added on analogous basic principles of clinical pharmacology. A presentation of multiple different perspectives on clinical epidemiology can be found in the second section. Due to major new methodological developments in the field, sections three and four have had new chapters added and others removed. The first three sections will be of interest to the neophyte while sections two through four will appeal to those with some background who want a more in-depth view of the field.

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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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Whitehouse David Molecular and Cellular Therapeutics


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Minghan Wang Metabolic Syndrome. Underlying Mechanisms and Drug Therapies


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Minghan Wang Metabolic Syndrome. Underlying Mechanisms and Drug Therapies


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Richard Kay Statistical Thinking for Non-Statisticians in Drug Regulation


Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials. Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis. Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry.

8153.41 РУБ

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G.S.N Sreevally Ravuri,Sunanda Sabbithi and Madhu Chandhaka Influence of antihyprtensive drug on metformin


Poly-pharmacy and multiple drug therapy assume importance in present day clinical practice, since newer molecules are invented everyday and newer challenges face clinicians in managing either a single disease or simultaneously occurring different diseases. The present study was under taken to verify the possible drug-drug interaction between an anti-hypertensive drug, Valsartan on hypoglycemic activity of Metformin. The whole study is divided into four phases, clearly explained in the study.

3212 РУБ

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