фармакология (страница 7)

Автор: Группа авторов

The book that highlights mass spectrometry and its application in characterizing proteins and peptides in drug discovery An instrumental analytical method for quantifying the mass and characterization of various samples from small molecules to large proteins, mass spectrometry (MS) has become one of the most widely used techniques for studying proteins and peptides over the last decade. Bringing together the work of experts in academia and industry, Protein and Peptide Mass Spectrometry in Drug Discovery highlights current analytical approaches, industry practices, and modern strategies for the characterization of both peptides and proteins in drug discovery. Illustrating the critical role MS technology plays in characterizing target proteins and protein products, the methods used, ion mobility, and the use of microwave radiation to speed proteolysis, the book also covers important emerging applications for neuroproteomics and antigenic peptides. Placing an emphasis on the pharmaceutical industry, the book stresses practice and applications, presenting real-world examples covering the most recent advances in mass spectrometry, and providing an invaluable resource for pharmaceutical scientists in industry and academia, analytical and bioanalytical chemists, and researchers in protein science and proteomics.

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Автор: Группа авторов

In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.

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Автор: Группа авторов

Innovative and forward-looking, this volume focuses on recent achievements in this rapidly progressing field and looks at future potential for development. The first part provides a basic understanding of the factors governing protein-ligand interactions, followed by a comparison of key experimental methods (calorimetry, surface plasmon resonance, NMR) used in generating interaction data. The second half of the book is devoted to insilico methods of modeling and predicting molecular recognition and binding, ranging from first principles-based to approximate ones. Here, as elsewhere in the book, emphasis is placed on novel approaches and recent improvements to established methods. The final part looks at unresolved challenges, and the strategies to address them. With the content relevant for all drug classes and therapeutic fields, this is an inspiring and often-consulted guide to the complexity of protein-ligand interaction modeling and analysis for both novices and experts.

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Автор: Группа авторов

Treating protein-protein interactions as a novel and highly promising class of drug targets, this volume introduces the underlying strategies step by step, from the biology of PPIs to biophysical and computational methods for their investigation. The main part of the book describes examples of protein targets for which small molecule modulators have been developed, covering such diverse fields as cancer, autoimmune disorders and infectious diseases. Tailor-made for the practicing medicinal chemist, this ready reference includes a wide selection of case studies taken straight from the development pipeline of major pharmaceutical companies to illustrate the power and potential of this approach. From the contents: * Prediction of intra- and inter-species protein-protein interactions facilitating systems biology studies * Modulators of protein-protein interactions: The importance of Three-Dimensionality * Interactive technologies for leveraging the known chemistry of anchor residues * SH3 Domains as Drug Targets * P53 MDM2 Antagonists: Towards Non Genotoxic Anticancer Treatments * Inhibition of LFA-1/ICAM interaction for treatment of autoimmune diseases * The PIF-binding pocket of AGC kinases * Peptidic inhibitors of protein-protein interactions for cell adhesion receptors * The REPLACE Strategy for generating Non-ATP competitive Inhibitors of Cell-Cycle Protein Kinases and more

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Автор: Группа авторов

Describes the latest advances in psychopharmacology – one of the most rapidly developing fields in modern science. This latest edition has been updated to cover new developments in drug therapy and research including newly introduced antipsychotics, antidepressants and antidementia drugs. Sections on the treatment of depression and dementia have been revised to include new developments in treatment strategies. It will be welcomed for its essentially clinical and psychological approach to modern pharmaceuticals, their therapeutic uses and limitations, adverse reactions and future directions for research.

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Автор: Burris Scott C

Public Health Law Research: Theory and Methods definitively explores the mechanisms, theories and models central to public health law research – a growing field dedicated to measuring and studying law as a central means for advancing public health. Editors Alexander C. Wagenaar and Scott Burris outline integrated theory drawn from numerous disciplines in the social and behavioral sciences; specific mechanisms of legal effect and guidelines for collecting and coding empirical datasets of statutory and case law; optimal research designs for randomized trials and natural experiments for public health law evaluation; and methods for qualitative and cost-benefit studies of law.. They also discuss the challenge of effectively translating the results of scientific evaluations into public health laws and highlight the impact of this growing field. “How exactly the law can best be used as a tool for protecting and enhancing the public’s health has long been the subject of solely opinion and anecdote. Enter Public Health Law Research, a discipline designed to bring the bright light of science to the relationships between law and health. This book is a giant step forward in illuminating that subject.” – Stephen Teret, JD, MPH, Professor, Director, Center for Law and the Public's Health, Johns Hopkins Bloomberg School of Public Health “Wagenaar and Burris bring a dose of much needed rigor to the empirical study of which public health law interventions really matter, and which don’t.” – Bernard S. Black, JD, Chabraja Professor, Northwestern University Law School and Kellogg School of Management Companion Web site: www.josseybass.com/go/wagenaar

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Автор: David Machin

The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies. The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis. This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical practice.

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Автор: David Machin

Quality of life studies form an essential part of the evaluation of any treatment. Written by two authors who are well respected within this field, Quality of Life: The Assessment, Analysis and Interpretation of Patient-reported Outcomes, Second Edition lays down guidelines on assessing, analysing and interpreting quality of life data. The new edition of this standard book has been completely revised, updated and expanded to reflect many methodological developments emerged since the publication of the first edition. Covers the design of instruments, the practical aspects of implementing assessment, the analyses of the data, and the interpretation of the results Presents all essential information on Quality of Life Research in one comprehensive volume Explains the use of qualitative and quantitative methods, including the application of basic statistical methods Includes copious practical examples Fills a need in a rapidly growing area of interest New edition accommodates significant methodological developments, and includes chapters on computer adaptive testing and item banking, choosing an instrument, systematic reviews and meta analysis This book is of interest for everyone involved in quality of life research, and it is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and practitioners in the fields of cancer and other chronic diseases. Reviews of the First Edition – Winner of the first prize in the Basis of Medicine Category of the BMA Medical Book Competition 2001: “This book is highly recommended to clinicians who are actively involved in the planning, analysis and publication of QoL research.” CLINICAL ONCOLOGY “This book is highly recommended reading.” QUALITY OF LIFE RESEARCH

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Автор: Daniel Pope

Quantitative Research Methods for Health Professionals: A Practical Interactive Course is a superb introduction to epidemiology, biostatistics, and research methodology for the whole health care community. Drawing examples from a wide range of health research, this practical handbook covers important contemporary health research methods such as survival analysis, Cox regression, and meta-analysis, the understanding of which go beyond introductory concepts. The book includes self-assessment exercises throughout to help students explore and reflect on their understanding and a clear distinction is made between a) knowledge and concepts that all students should ensure they understand and b) those that can be pursued by students who wish to do so. The authors incorporate a program of practical exercises in SPSS using a prepared data set that helps to consolidate the theory and develop skills and confidence in data handling, analysis and interpretation.

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Автор: David Machin

Randomi sed Clinical Trials: Design, Practice and Reporting  provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process.  This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book:  Provides comprehensive coverage of randomised clinical trials, ranging from basic to advanced Features several new chapters, updated case studies and examples, and references to changes in regulations Explains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure Covers paired trial designs and trials with more than two interventions Includes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test  Randomi sed Clinical Trials  is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.

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Автор: Laplante Phillip A

The leading text in the field explains step by step how to write software that responds in real time From power plants to medicine to avionics, the world increasingly depends on computer systems that can compute and respond to various excitations in real time. The Fourth Edition of Real-Time Systems Design and Analysis gives software designers the knowledge and the tools needed to create real-time software using a holistic, systems-based approach. The text covers computer architecture and organization, operating systems, software engineering, programming languages, and compiler theory, all from the perspective of real-time systems design. The Fourth Edition of this renowned text brings it thoroughly up to date with the latest technological advances and applications. This fully updated edition includes coverage of the following concepts: Multidisciplinary design challenges Time-triggered architectures Architectural advancements Automatic code generation Peripheral interfacing Life-cycle processes The final chapter of the text offers an expert perspective on the future of real-time systems and their applications. The text is self-contained, enabling instructors and readers to focus on the material that is most important to their needs and interests. Suggestions for additional readings guide readers to more in-depth discussions on each individual topic. In addition, each chapter features exercises ranging from simple to challenging to help readers progressively build and fine-tune their ability to design their own real-time software programs. Now fully up to date with the latest technological advances and applications in the field, Real-Time Systems Design and Analysis remains the top choice for students and software engineers who want to design better and faster real-time systems at minimum cost.

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Автор: Rossi John J

RNA Interference: Application to Drug Discovery and Challenges to Pharmaceutical Development provides a general overview of this rapidly emerging field, with a strong emphasis on issues and aspects that are important to a drug development team. The first part covers more general background of RNA interference and its application in drug discovery. In the second part, the book addresses siRNA (small interfering RNA), a pharmaceutically potent form, and its use and delivery in therapeutics along with manufacturing and delivery aspects.

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Автор: Ricardo Maronna A

A new edition of this popular text on robust statistics, thoroughly updated to include new and improved methods and focus on implementation of methodology using the increasingly popular open-source software R. Classical statistics fail to cope well with outliers associated with deviations from standard distributions. Robust statistical methods take into account these deviations when estimating the parameters of parametric models, thus increasing the reliability of fitted models and associated inference. This new, second edition of Robust Statistics: Theory and Methods (with R) presents a broad coverage of the theory of robust statistics that is integrated with computing methods and applications. Updated to include important new research results of the last decade and focus on the use of the popular software package R, it features in-depth coverage of the key methodology, including regression, multivariate analysis, and time series modeling. The book is illustrated throughout by a range of examples and applications that are supported by a companion website featuring data sets and R code that allow the reader to reproduce the examples given in the book. Unlike other books on the market, Robust Statistics: Theory and Methods (with R) offers the most comprehensive, definitive, and up-to-date treatment of the subject. It features chapters on estimating location and scale; measuring robustness; linear regression with fixed and with random predictors; multivariate analysis; generalized linear models; time series; numerical algorithms; and asymptotic theory of M-estimates. Explains both the use and theoretical justification of robust methods Guides readers in selecting and using the most appropriate robust methods for their problems Features computational algorithms for the core methods Robust statistics research results of the last decade included in this 2nd edition include: fast deterministic robust regression, finite-sample robustness, robust regularized regression, robust location and scatter estimation with missing data, robust estimation with independent outliers in variables, and robust mixed linear models. Robust Statistics aims to stimulate the use of robust methods as a powerful tool to increase the reliability and accuracy of statistical modelling and data analysis. It is an ideal resource for researchers, practitioners, and graduate students in statistics, engineering, computer science, and physical and social sciences.

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Автор: Ricardo Maronna A

A new edition of this popular text on robust statistics, thoroughly updated to include new and improved methods and focus on implementation of methodology using the increasingly popular open-source software R. Classical statistics fail to cope well with outliers associated with deviations from standard distributions. Robust statistical methods take into account these deviations when estimating the parameters of parametric models, thus increasing the reliability of fitted models and associated inference. This new, second edition of Robust Statistics: Theory and Methods (with R) presents a broad coverage of the theory of robust statistics that is integrated with computing methods and applications. Updated to include important new research results of the last decade and focus on the use of the popular software package R, it features in-depth coverage of the key methodology, including regression, multivariate analysis, and time series modeling. The book is illustrated throughout by a range of examples and applications that are supported by a companion website featuring data sets and R code that allow the reader to reproduce the examples given in the book. Unlike other books on the market, Robust Statistics: Theory and Methods (with R) offers the most comprehensive, definitive, and up-to-date treatment of the subject. It features chapters on estimating location and scale; measuring robustness; linear regression with fixed and with random predictors; multivariate analysis; generalized linear models; time series; numerical algorithms; and asymptotic theory of M-estimates. Explains both the use and theoretical justification of robust methods Guides readers in selecting and using the most appropriate robust methods for their problems Features computational algorithms for the core methods Robust statistics research results of the last decade included in this 2nd edition include: fast deterministic robust regression, finite-sample robustness, robust regularized regression, robust location and scatter estimation with missing data, robust estimation with independent outliers in variables, and robust mixed linear models. Robust Statistics aims to stimulate the use of robust methods as a powerful tool to increase the reliability and accuracy of statistical modelling and data analysis. It is an ideal resource for researchers, practitioners, and graduate students in statistics, engineering, computer science, and physical and social sciences.

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Автор: Группа авторов

Rossi's Principles of Transfusion Medicine is the most comprehensive and practical reference on transfusion science and medicine available Led by a world class Editor team, including two past-presidents of AABB, a past- President of the American Board of Pathology and members of the FDA Blood Products Advisory Committee , and international contributor team Comprehensive reference resource, considered the gold standard in transfusion Covers current hot topics such as donor care – including the frequency of donation and management of iron deficiency/status), patient blood management, hemovigilance, cstem cell therapies, and global aspects of the organization of transfusion and transplant services New material on molecular immunohematology Companion website includes figures, full text and references

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Автор: Alan C. Elliott

A step-by-step introduction to using SAS® statistical software as a foundational approach to data analysis and interpretation Presenting a straightforward introduction from the ground up, SAS® Essentials: Mastering SAS for Data Analytics, Second Edition illustrates SAS using hands-on learning techniques and numerous real-world examples. Keeping different experience levels in mind, the highly-qualified author team has developed the book over 20 years of teaching introductory SAS courses. Divided into two sections, the first part of the book provides an introduction to data manipulation, statistical techniques, and the SAS programming language. The second section is designed to introduce users to statistical analysis using SAS Procedures. Featuring self-contained chapters to enhance the learning process, the Second Edition also includes: Programming approaches for the most up-to-date version of the SAS platform including information on how to use the SAS University Edition Discussions to illustrate the concepts and highlight key fundamental computational skills that are utilized by business, government, and organizations alike New chapters on reporting results in tables and factor analysis Additional information on the DATA step for data management with an emphasis on importing data from other sources, combining data sets, and data cleaning Updated ANOVA and regression examples as well as other data analysis techniques A companion website with the discussed data sets, additional code, and related PowerPoint® slides SAS Essentials: Mastering SAS for Data Analytics, Second Edition is an ideal textbook for upper-undergraduate and graduate-level courses in statistics, data analytics, applied SAS programming, and statistical computer applications as well as an excellent supplement for statistical methodology courses. The book is an appropriate reference for researchers and academicians who require a basic introduction to SAS for statistical analysis and for preparation for the Basic SAS Certification Exam.

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Автор: Группа авторов

This first systematic treatment of the concept and practice of scaffold hopping shows the tricks of the trade and provides invaluable guidance for the reader's own projects. The first section serves as an introduction to the topic by describing the concept of scaffolds, their discovery, diversity and representation, and their importance for finding new chemical entities. The following part describes the most common tools and methods for scaffold hopping, whether topological, shape-based or structure-based. Methods such as CATS, Feature Trees, Feature Point Pharmacophores (FEPOPS), and SkelGen are discussed among many others. The final part contains three fully documented real-world examples of successful drug development projects by scaffold hopping that illustrate the benefits of the approach for medicinal chemistry. While most of the case studies are taken from medicinal chemistry, chemical and structural biologists will also benefit greatly from the insights presented here.

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Автор: Reuven Y. Rubinstein

This accessible new edition explores the major topics in Monte Carlo simulation that have arisen over the past 30 years and presents a sound foundation for problem solving Simulation and the Monte Carlo Method, Third Edition reflects the latest developments in the field and presents a fully updated and comprehensive account of the state-of-the-art theory, methods and applications that have emerged in Monte Carlo simulation since the publication of the classic First Edition over more than a quarter of a century ago. While maintaining its accessible and intuitive approach, this revised edition features a wealth of up-to-date information that facilitates a deeper understanding of problem solving across a wide array of subject areas, such as engineering, statistics, computer science, mathematics, and the physical and life sciences. The book begins with a modernized introduction that addresses the basic concepts of probability, Markov processes, and convex optimization. Subsequent chapters discuss the dramatic changes that have occurred in the field of the Monte Carlo method, with coverage of many modern topics including: Markov Chain Monte Carlo, variance reduction techniques such as importance (re-)sampling, and the transform likelihood ratio method, the score function method for sensitivity analysis, the stochastic approximation method and the stochastic counter-part method for Monte Carlo optimization, the cross-entropy method for rare events estimation and combinatorial optimization, and application of Monte Carlo techniques for counting problems. An extensive range of exercises is provided at the end of each chapter, as well as a generous sampling of applied examples. The Third Edition features a new chapter on the highly versatile splitting method, with applications to rare-event estimation, counting, sampling, and optimization. A second new chapter introduces the stochastic enumeration method, which is a new fast sequential Monte Carlo method for tree search. In addition, the Third Edition features new material on: • Random number generation, including multiple-recursive generators and the Mersenne Twister • Simulation of Gaussian processes, Brownian motion, and diffusion processes • Multilevel Monte Carlo method • New enhancements of the cross-entropy (CE) method, including the “improved” CE method, which uses sampling from the zero-variance distribution to find the optimal importance sampling parameters • Over 100 algorithms in modern pseudo code with flow control • Over 25 new exercises Simulation and the Monte Carlo Method, Third Edition is an excellent text for upper-undergraduate and beginning graduate courses in stochastic simulation and Monte Carlo techniques. The book also serves as a valuable reference for professionals who would like to achieve a more formal understanding of the Monte Carlo method. Reuven Y. Rubinstein, DSc, was Professor Emeritus in the Faculty of Industrial Engineering and Management at Technion-Israel Institute of Technology. He served as a consultant at numerous large-scale organizations, such as IBM, Motorola, and NEC. The author of over 100 articles and six books, Dr. Rubinstein was also the inventor of the popular score-function method in simulation analysis and generic cross-entropy methods for combinatorial optimization and counting. Dirk P. Kroese, PhD, is a Professor of Mathematics and Statistics in the School of Mathematics and Physics of The University of Queensland, Australia. He has published over 100 articles and four books in a wide range of areas in applied probability and statistics, including Monte Carlo methods, cross-entropy, randomized algorithms, tele-traffic c theory, reliability, computational statistics, applied probability, and stochastic modeling.

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Автор: CIBA Foundation Symposium

The Novartis Foundation Series is a popular collection of the proceedings from Novartis Foundation Symposia, in which groups of leading scientists from a range of topics across biology, chemistry and medicine assembled to present papers and discuss results. The Novartis Foundation, originally known as the Ciba Foundation, is well known to scientists and clinicians around the world.

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Автор: Группа авторов

Written by a well-known lecturer and consultant to the pharmaceutical industry, this book focuses on the pharmaceutical non-statistician working within a very strict regulatory environment. Statistical Thinking for Clinical Trials in Drug Regulation presents the concepts and statistical thinking behind medical studies with a direct connection to the regulatory environment so that readers can be clear where the statistical methodology fits in with industry requirements. Pharmaceutical-related examples are used throughout to set the information in context. As a result, this book provides a detailed overview of the statistical aspects of the design, conduct, analysis and presentation of data from clinical trials within drug regulation. Statistical Thinking for Clinical Trials in Drug Regulation: Assists pharmaceutical personnel in communicating effectively with statisticians using statistical language Improves the ability to read and understand statistical methodology in papers and reports and to critically appraise that methodology Helps to understand the statistical aspects of the regulatory framework better quoting extensively from regulatory guidelines issued by the EMEA (European Medicines Evaluation Agency), ICH (International Committee on Harmonization and the FDA (Food and Drug Administration)

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Автор: Richard Kay

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.

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Автор: Schuenemeyer John

A comprehensive treatment of statistical applications for solving real-world environmental problems A host of complex problems face today's earth science community, such as evaluating the supply of remaining non-renewable energy resources, assessing the impact of people on the environment, understanding climate change, and managing the use of water. Proper collection and analysis of data using statistical techniques contributes significantly toward the solution of these problems. Statistics for Earth and Environmental Scientists presents important statistical concepts through data analytic tools and shows readers how to apply them to real-world problems. The authors present several different statistical approaches to the environmental sciences, including Bayesian and nonparametric methodologies. The book begins with an introduction to types of data, evaluation of data, modeling and estimation, random variation, and sampling—all of which are explored through case studies that use real data from earth science applications. Subsequent chapters focus on principles of modeling and the key methods and techniques for analyzing scientific data, including: Interval estimation and Methods for analyzinghypothesis testing of means time series data Spatial statistics Multivariate analysis Discrete distributions Experimental design Most statistical models are introduced by concept and application, given as equations, and then accompanied by heuristic justification rather than a formal proof. Data analysis, model building, and statistical inference are stressed throughout, and readers are encouraged to collect their own data to incorporate into the exercises at the end of each chapter. Most data sets, graphs, and analyses are computed using R, but can be worked with using any statistical computing software. A related website features additional data sets, answers to selected exercises, and R code for the book's examples. Statistics for Earth and Environmental Scientists is an excellent book for courses on quantitative methods in geology, geography, natural resources, and environmental sciences at the upper-undergraduate and graduate levels. It is also a valuable reference for earth scientists, geologists, hydrologists, and environmental statisticians who collect and analyze data in their everyday work.

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Автор: Arun K. Ghosh

Drug design is a complex, challenging and innovative research area. Structure-based molecular design has transformed the drug discovery approach in modern medicine. Traditionally, focus has been placed on computational, structural or synthetic methods only in isolation. This one-of-akind guide integrates all three skill sets for a complete picture of contemporary structure-based design. This practical approach provides the tools to develop a high-affinity ligand with drug-like properties for a given drug target for which a high-resolution structure exists. The authors use numerous examples of recently developed drugs to present «best practice» methods in structurebased drug design with both newcomers and practicing researchers in mind. By way of a carefully balanced mix of theoretical background and case studies from medicinal chemistry applications, readers will quickly and efficiently master the basic skills of successful drug design. This book is aimed at new and active medicinal chemists, biochemists, pharmacologists, natural product chemists and those working in drug discovery in the pharmaceutical industry. It is highly recommended as a desk reference to guide students in medicinal and chemical sciences as well as to aid researchers engaged in drug design today.

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Автор: Группа авторов

The first volume of the book series «Successful Drug Discovery» is focusing on new drug discoveries during the last decade, from established drugs to recently introduced drugs of all kinds: small-molecule-, peptide-, and protein-based drugs. The role of serendipity is analyzed in some very successful drugs where the research targets of the lead molecule and the drug are different. Phenotypic and target-based drug discovery approaches are discussed from the viewpoint of pioneer drugs and analogues. This volume gives an excellent overview of insulin analogues including a discussion of the properties of rapid-acting and long-acting formulations of this important hormone. The major part of the book is devoted to case histories of new drug discoveries described by their key inventors. Eight case histories range across many therapeutic fields. The goal of this book series is to help the participants of the drug research community with a reference book series and to support teaching in medicinal chemistry with case histories and review articles of new drugs.

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Автор: Группа авторов

Filled with unique insights into current drugs that have made it to the marketplace In the fifth volume of Successful Drug Discovery, the inventors and primary developers of drugs that made it to the market tell the story of the drug's discovery and development. Case studies of drugs from different therapeutic fields reveal the all-too-often unpredictable path from the first drug candidate molecule to the successfully marketed drug. In addition, this new volume addresses overarching topics for drug discovery, such as drug discovery in academia, and discusses currently important classes of small molecule as well as biological drugs. Comprehensive in scope, the book's nine chapters provide a representative cross-section of the present-day drug development effort. The authoritative fifth volume is filled with relevant data and chemical information, as well as the insight and experience of the best contemporary drug creators. This important volume: – Puts the focus on recently introduced drugs that have not yet made it into standard textbooks or general references – Contains information and insight that is new and often not even available from the primary literature  – Reveals what it takes to successfully develop a drug molecule that has made it all the way to the market  – Is endorsed and supported by the International Union of Pure and Applied Chemistry (IUPAC) Written for medicinal chemists, pharmaceutical chemists, organic chemists, Successful Drug Discovery, Volume Five reveals the most recent techniques used by drug innovators in the drug development process.

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Автор: Hedley Rees

This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.

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Автор: David Machin

Well received in its first edition, Survival Analysis: A Practical Approach is completely revised to provide an accessible and practical guide to survival analysis techniques in diverse environments. Illustrated with many authentic examples, the book introduces basic statistical concepts and methods to construct survival curves, later developing them to encompass more specialised and complex models. During the years since the first edition there have been several new topics that have come to the fore and many new applications. Parallel developments in computer software programmes, used to implement these methodologies, are relied upon throughout the text to bring it up to date.

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Автор: Alison Blenkinsopp

A practical and evidence-based guide for student, pre-registration and qualified pharmacists Symptoms in the Pharmacy is an indispensable guide to the management of common symptoms seen in the pharmacy. With advice from an author team that includes both pharmacists and GPs, the book covers ailments which will be encountered in the pharmacy on a daily basis. Now in its sixth edition Symptoms in the Pharmacy has been fully revised to reflect the latest evidence and availability of new medicines. There are new sections and case studies for 'POM' to 'P' switches including chloramphenicol, sumatriptan, diclofenac, naproxen and amorolfine. This edition features colour photographs of skin conditions for the first time enabling the differentiation and diagnosis of common complaints. The public health and illness prevention content have been expanded to support this increasingly important aspect of the pharmacist’s work. The book is designed for quick and easy reference with separate chapters for each ailment. Each chapter incorporates a decision making framework in which the information necessary for treatment and suggestions on ‘when to refer’ is distilled into helpful summary boxes. At the end of each chapter there are example case studies providing the view of pharmacists, doctors and patients for most conditions covered. These easy-to-follow- chapters can be read cover to cover or turned to for quick reference. This useful guide should be kept close at hand for frequent consultation.

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Автор: Группа авторов

The book series 'Polymer Nano-, Micro- and Macrocomposites' provides complete and comprehensive information on all important aspects of polymer composite research and development, including, but not limited to synthesis, filler modification, modeling, characterization as well as application and commercialization issues. Each book focuses on a particular topic and gives a balanced in-depth overview of the respective subfield of polymer composite science and its relation to industrial applications. With the books the readers obtain dedicated resources with information relevant to their research, thereby helping to save time and money. Summarizing all the most important synthesis techniques used in the lab as well as in industry, this book is comprehensive in its coverage from chemical, physical and mechanical viewpoints. This book helps readers to choose the correct synthesis route, such as suspension and miniemulsion polymerization, living polymerization, sonication, mechanical methods or the use of radiation, and so achieve the desired composite properties.

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Автор: Ekins Sean

Apply adaptive research to improve results in drug development The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available tools and techniques, can enable the industry to streamline clinical trials and reach decision points faster and more efficiently. With a wealth of real-world cases and examples, author Michael Rosenberg gives readers a practical overview of drug development, the problems inherent in current practices, and the advantages of adaptive research technology and methods. He explains the concepts, principles, and specific techniques of adaptive research, and demonstrates why it is an essential evolutionary step toward improving drug research and development. Chapters explore such subjects as: The adaptive concept Design and operational adaptations Sample-size reestimation Agile clinical development Safety and dose finding Statistics in adaptive research, including frequentist and Bayesian approaches Data management technologies The future of clinical development By combining centuries-old intellectual foundations, recent technological advances, and modern management techniques, adaptive research preserves the integrity and validity of clinical research but dramatically improves efficiency.

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Автор: Joan Marsh

Nicotine is considered to be the main agent in the maintenance of the tobacco smoking habit and is largely responsible for the behavioral and physiological responses to the inhalation of tobacco smoke. This work presents advances made in the elucidation of the action of nicotine in the body–essential information for developing treatments to help people give up smoking. The book reviews the progress made in identifying nicotinic acetylcholine receptors in the brain, using the techniques of molecular biology to characterize receptors and investigate the functional differences between receptors composed of different types of subunits. Sex-specific differences in the response to nicotine, the effects of nicotine on locomotor activity, and its still-debated influence on cognitive performance are considered. The book also examines the habit-forming role of nicotine, the development of tolerance to nicotine, and the less clearly understood phenomenon of withdrawal. Also discusses some potential therapeutic strategies.

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Автор: Sean Ekins

A unique, integrative look at information-based medicine The convergence of medical science, biology, pharmacology, biomedical engineering, healthcare, and information technology is revolutionizing medical and scientific practice, and has broader social implications still being understood. The Engines of Hippocrates provides a unique, integrative, and holistic look at the new paradigm of information-based medicine, covering a broad range of topics for a wide readership. The authors take a comprehensive approach, examining the prehistory, history, and future of medicine and medical technology and its relation to information; how history led to such present-day discoveries as the structure of DNA, the human genome, and the discipline of bioinformatics; and what the future results of these discoveries may hold. Their far-ranging views are their own and not necessarily those of the IBM Corporation or other employers. The Engines of Hippocrates helps readers understand: Forces shaping the pharmaceutical and biomedical industries today, including personalized medicine, genomics, data mining, and bionanotechnology The relationship between pharmaceutical science today and other disciplines such as philosophy of health, history, economics, mathematics, and computer science The integrated role alternative and non-Western medicines could play in a new, information-based medicine Practical, ethical, organizational, technological, and social problems of information-based medicine, along with a novel data-centric computing model and a self-adaptive software engineering model, and corresponding information technology architectures, including perspectives on sharing remote data efficiently and securely for the common good An unmatched, cross-disciplinary perspective on the big picture of today and tomorrow's medicine, The Engines of Hippocrates provides a reference to interested readers both inside and outside the pharmaceutical and medical communities, as well as a peerless classroom supplement to students in a wide variety of disciplines.

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Автор: P. Michael Dubinsky

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

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Автор: P. Michael Dubinsky

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Автор: Группа авторов

This book represents the definitive research collection for corporate social responsibility communication, offering cross-disciplinary and international perspectives from the top scholars in the field. Addresses a gap in the existing CSR literature Demonstrates the relevance of effective CSR communication for the management of organizations The 28 contributions come from top scholars in public relations, organizational communication, reputation management, marketing and management

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Автор: Sukhdev Chatu

Are you about to sit your pharmacology exams? Do you lack confidence in prescribing? Would it help to have a quick reference, pocket-sized reassurance on common drugs and the conditions that they are used in? The Hands-on Guide to Clinical Pharmacology is the perfect companion for students, doctors, nurses, pharmacists and other health care professionals who need help on the ward or are preparing for exams. It includes sections containing both treatment regimens of common conditions and detailed information on the relevant drugs that help you obtain a better understanding of therapeutic management. The benefits include: A-Z of over 100 key drugs in a one-drug-per-page format A systems-based approach Fully indexed text Clear explanations of drug mechanisms – a regular feature of pharmacology exams Management guidelines for common conditions within each system Brand new two-colour design to help with information retrieval A new chapter on chemotherapy agents Take the stress out of clinical pharmacology with The Hands-on Guide!

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Автор: Sukhdev Chatu

Are you about to sit your pharmacology exams? Do you lack confidence in prescribing? Would it help to have a quick reference, pocket-sized reassurance on common drugs and the conditions that they are used in? The Hands-on Guide to Clinical Pharmacology is the perfect companion for students, doctors, nurses, pharmacists and other health care professionals who need help on the ward or are preparing for exams. It includes sections containing both treatment regimens of common conditions and detailed information on the relevant drugs that help you obtain a better understanding of therapeutic management. The benefits include: A-Z of over 100 key drugs in a one-drug-per-page format A systems-based approach Fully indexed text Clear explanations of drug mechanisms – a regular feature of pharmacology exams Management guidelines for common conditions within each system Brand new two-colour design to help with information retrieval A new chapter on chemotherapy agents Take the stress out of clinical pharmacology with The Hands-on Guide!

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Автор: Группа авторов

Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams. Moreover, this reference provides guidance on: Directing and carrying out specific tasks and courses of action Making and communicating clear and achievable decisions Solving problems on the spot Managing the administrative aspects of chemical process development The author, Dr. Derek Walker, has directed chemical process development work for four decades, combining firsthand chemical synthesis experience with many other disciplines needed to create chemical processes. You will benefit from his advice and unique insights into: Understanding the workings of matrix organizations Defining missions and creating action plans Developing interdisciplinary approaches to problem solving Holding review meetings, revising goals, and motivating staff Prioritizing programs and responses to emergencies In addition, you'll learn how successful chemists, in collaboration with other disciplines, define the best (green) chemistry for process scale-up, including accommodating FDA requirements in the last process steps and addressing safety and environmental matters early in their work. Case studies provide incisive perspective on these issues. A chapter on recognizing and patenting intellectual property emphasizes the importance of comprehensive literature surveys and understanding invention. A chapter on the future challenges you to think beyond narrow constraints and explore new horizons.

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Автор: K. Downey

This key document, produced by the BFS IOA, outlines important aspects on operation of BFS technology to ensure both compliance with cGMP regulations and the production of drug products of the appropriate quality, safety and efficacy. The Points to Consider document provides recommendations specific to the operation of Blow-Fill-Seal technology for the manufacture of sterile pharmaceuticals and liquid medical devices. One of the aims of this document is to define the minimum standards expected and to develop consistency across all users of BFS technology for the manufacture of drug products.The Pharmaceutical Blow-Fill-Seal International Operators Association (BFS IOA) is an international industry association for pharmaceutical and associated companies, which have a direct or indirect involvement with Blow-Fill-Seal (BFS) manufacturing. BFS IOA is a non-profit organization, and is financed by subscription of more than 60 member companies worldwide and by sponsorships from the industry.

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Автор: Ozgur Ergul

The Multilevel Fast Multipole Algorithm (MLFMA) for Solving Large-Scale Computational Electromagnetic Problems provides a detailed and instructional overview of implementing MLFMA. The book: Presents a comprehensive treatment of the MLFMA algorithm, including basic linear algebra concepts, recent developments on the parallel computation, and a number of application examples Covers solutions of electromagnetic problems involving dielectric objects and perfectly-conducting objects Discusses applications including scattering from airborne targets, scattering from red blood cells, radiation from antennas and arrays, metamaterials etc. Is written by authors who have more than 25 years experience on the development and implementation of MLFMA The book will be useful for post-graduate students, researchers, and academics, studying in the areas of computational electromagnetics, numerical analysis, and computer science, and who would like to implement and develop rigorous simulation environments based on MLFMA.

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Автор: Pierre Levy

The new digital media offers us an unprecedented memory capacity, an ubiquitous communication channel and a growing computing power. How can we exploit this medium to augment our personal and social cognitive processes at the service of human development? Combining a deep knowledge of humanities and social sciences as well as a real familiarity with computer science issues, this book explains the collaborative construction of a global hypercortex coordinated by a computable metalanguage. By recognizing fully the symbolic and social nature of human cognition, we could transform our current opaque global brain into a reflexive collective intelligence.

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Автор: John O'Grady

New edition of succesful standard reference book for the pharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebook for the Diploma in Pharmaceutical Medicine, and is used as a standard reference throughout the pharmaceutical industry. The new edition includes greater coverage of good clinical practice, a completely revised statistics chapter, and more on safety. Covers the course information for the Diploma in Pharmaceutical Medicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe and regulation of therapeutic products in Australia

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Автор: Группа авторов

The Textbook of Pharmaceutical Medicine is the standard reference for everyone working and learning in pharmaceutical medicine. It is a comprehensive resource covering the processes and practices by which medicines are developed, tested and approved, and the recognised text for the Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine. This fully revised Seventh Edition, which includes two new Editors, encompasses current developments within pharmaceutical medicine with new chapters on biological therapeutics, pharmacovigilance, vaccines, drugs for cancer, drug development in paediatrics and neonatalogy, the clinical trials directive, life cycle management of medicines, counterfeit medicines and medical marketing. Also included for easy reference, and referred to throughout the text, are the Declaration of Helsinki, Guidelines and Documentation for Implementation of Clinical Trials, relevant European Directives and the Syllabus for Pharmaceutical Medicine. Written by an international team of leading academics, medical directors and lawyers, The Textbook of Pharmaceutical Medicine, Seventh Edition meets the needs of both those working in pharmaceutical medicine and preparing for the Diploma in Pharmaceutical Medicine. The text breaks down into three core sections: Part I: Research and Development Part II: Regulation Part III: Healthcare marketplace View Table of Contents in detail

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Автор: Группа авторов

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Автор: Группа авторов

Edited by three pioneers in the field, each with longstanding experience in the biotech industry, and a skilled scientific writer, this is the first book to cover every step in the development and production of immunoglobulin Fc-fusion proteins as therapeutics for human disease: from choosing the right molecular design, to pre-clinical characterization of the purified product, through to batch optimization and quality control for large-scale cGMP production. The whole of the second part is devoted to case studies of Fc-fusion proteins that are now commercially successful products. In this section, the authors, several of whom were personally involved in clinical development of the products themselves, detail the product?s background and give insight into issues that were faced and how these issues were overcome during clinical development. This section also includes a chapter on promising new developments for the future. An invaluable resource for professionals already working on Fc-fusion proteins and an excellent and thorough introduction for physicians, researchers, and students entering the field.

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Автор: Mecozzi Sandro

Designed for pharmacy students Now updated for its Second Edition, Thermodynamics of Pharmaceutical Systems provides pharmacy students with a much-needed introduction to the mathematical intricacies of thermodynamics in relation to practical laboratory applications. Designed to meet the needs of the contemporary curriculum in pharmacy schools, the text makes these connections clear, emphasizing specific applications to pharmaceutical systems including dosage forms and newer drug delivery systems. Students and practitioners involved in drug discovery, drug delivery, and drug action will benefit from Connors' and Mecozzi's authoritative treatment of the fundamentals of thermodynamics as well as their attention to drug molecules and experimental considerations. They will appreciate, as well, the significant revisions to the Second Edition. Expanding the book's scope and usefulness, the new edition: Explores in greater depth topics most relevant to the pharmacist such as drug discovery and drug delivery, supramolecular chemistry, molecular recognition, and nanotechnologies Moves the popular review of mathematics, formerly an appendix, to the front of the book Adds new textual material and figures in several places, most notably in the chapter treating noncovalent chemical interactions Two new appendices provide ancillary material that expands on certain matters bordering the subject of classical thermodynamics Thermodynamics need not be a mystery nor confined to the realm of mathematical theory. Thermodynamics of Pharmaceutical Systems, Second Edition demystifies for students the profound thermodynamic applications in the laboratory while also serving as a handy resource for practicing researchers.

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Автор: Группа авторов

Studies of thermodynamics often fail to demonstrate how the mathematical intricacies of the subject relate to practical laboratory applications. Thermodynamics of Pharmaceutical Systems makes these connections clear, emphasizing specific applications to pharmaceutical systems in a study created specifically for contemporary curriculums at colleges of pharmacy. Students investigating drug discovery, drug delivery, and drug action will benefit from Kenneth Connors’s authoritative treatment of the fundamentals of thermodynamics as well as his attention to drug molecules and experimental considerations. An extensive appendix that reviews the mathematics needed to master the pharmacy curriculum proves an invaluable reference. Connors divides his one-of-a-kind text into three sections: Basic Thermodynamics, Thermodynamics of Physical Processes, and Thermodynamics of Chemical Processes; chapters include: Energy and the First Law of Thermodynamics The Entropy Concept Phase Transformations Solubility Acid-Base Equilibria Noncovalent Binding Equilibria Thermodynamics need not be a mystery nor be confined to the realm of mathematical theory. Thermodynamics of Pharmaceutical Systems introduces students of pharmacy to the profound thermodynamic applications in the laboratory while also serving as a handy resource for practicing researchers.

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Автор: Benson Heather A.E

Practical drug development approaches presented by leading experts Designed to support the development of new, effective therapeutics, Topical and Transdermal Drug Delivery: Principles and Practice explains the principles underlying the field and then demonstrates how these principles are put into practice in the design and development of new drug products. Drawing together and reviewing the latest research findings, the book focuses on practical, tested, and proven approaches that are backed by industry case studies and the authors' firsthand experience. Moreover, the book emphasizes the mechanistic information that is essential for successful drug product development. Topical and Transdermal Drug Delivery: Principles and Practice is divided into two parts: Part One, Current Science, Skin Permeation, and Enhancement Approaches, offers readers a fundamental understanding of the underlying science in the field. It describes the principles and techniques needed to successfully perform experimental approaches, covering such issues as skin permeation, enhancement, and assessment. Part Two, Topical and Transdermal Product Development, guides readers through the complete product development process from concept to approval, offering practical tips and cautions from experts in the field. This part also discusses regulations that are specific to the development of dermal drug products. The final chapter explores current and future trends, forecasting new development techniques and therapeutics. Throughout the book, the authors clearly set forth the basic science and experimental procedures, making it possible for researchers to design their own experimental approaches and accurately interpret their results. With contributions from experienced drug researchers, this text is highly recommended for all researchers involved in topical and transdermal product development who need to know both the state of the science and the standards of practice.

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Автор: Souzan B. Yanni

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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Автор: Albert P. Li

This book provides a comprehensive and up-to-date coverage of the relationship between drug metabolism enzymes and transporters on drug toxicity, along with methods to investigate their role on adverse drug reactions. Unites both the metabolism and transporter components of drug toxicity – two aspects not normally connected and the latter often neglected Familiarizes readers with the mechanism and species differences in drug metabolizing enzymes and transporters Discusses promising approaches to accurately predict human drug toxicity via the incorporation of human drug metabolism in toxicity evaluation

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Автор: Группа авторов

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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