Phylogenetic presentation of medicinal plants and a chemotaxonomical rationale of antiviral, antibacterial, and antifungal action. Discusses chemical structure-activity relationship, pharmacokinetics, and oral bioavailability of antimicrobial principles Introduces the molecular mechanism of natural products on viruses, bacteria, and fungi. Contains a selection of hand-made botanical plates and useful bibliographic references A useful research tool for postgraduates, academics, and the pharmaceutical, herbal, or nutrition industries.

Microbial infection is increasingly seen as a problem as we begin to run out of antibiotics. Understanding how microbes cause disease is essential. In recent years it has begun to emerge that bacteria, fungi, protozoa and viruses can use their cell stress proteins to cause infection. This volume brings together the world's leading experts in the study of the microbial and human cell stress proteins that are involved in enabling microorganisms to infect humans and cause serious disease.

Medicinal Chemistry: A Look at How Drugs Are Discovered is written for those who are interested in learning how drugs are discovered. Compared to other books on the market, this text takes a different approach by presenting the subject on chemical reaction mechanism terms, which ideally makes the subject matter more interesting and easier to comprehend. The authors describe the drug discovery process, from advancing an initial lead to the approval process, and include drug discovery sources. Additional features: Explains medicinal chemistry on chemical mechanism terms, allowing for a more interesting and easier to comprehend text Includes valuable insights toward the various pathways taken at pharmaceutical industries in drug discoveries Improved by including questions raised and suggestions made from students in the authors' medicinal chemistry classes This book will benefit both upper level undergraduates and graduates studying in the fields of medicinal chemistry and drug discovery, as well as scientists working in the pharmaceutical industry.

Genetically-engineered mouse models for cancer research have become invaluable tools for studying cancer biology and evaluating novel therapeutic approaches. This volume focuses on state-of-the-art methods for generating, analyzing and validating such models for studying aspects of human cancer biology. Additionally, these models are emerging as important pre-clinical systems in which to test cancer prevention and therapeutic strategies in order to select compounds for testing in clinical trials.

The conceptual process of drug discovery is one that is often the result of an identified need in a defined disease area. This need represents a mandate from the marketing department of a phar- maceutical company or a breakthrough at the research level that has agreed applicability in response to a valid therapeutic demand. Although the intelligent design and development of new thera- peutic entities, as evidenced by Sir James Black's H -receptor an- 2 tagonist cimetidine (Tagamet), is intellectually satisfying, many novel drugs arise from serendipity, from the chance observation of the research scientist or the clinician, that a compound has unex- pected actions of use for the treatment of human disease states. Drugs that have been identified by this route include the antipsy- chotic chlorpromazine and the putative anxiolytic buspirone. The events surrounding the process of drug discovery and de- velopment are the theme of the present volume, which attempts to present, in a logical and lucid manner, the complexity of a process that is often naively assumed to represent nothing more than the identification of a new compound and its rapid introduction into humans, free of such complications as efficacy, selectivity, safety, bioavailability, toxicity, and need.

The Springer Handbook of Enzymes provides concise data on some 5,000 enzymes sufficiently well characterized and here is the second, updated edition. Their application in analytical, synthetic and biotechnology processes as well as in food industry, and for medicinal treatments is added. Data sheets are arranged in their EC-Number sequence. The new edition reflects considerable progress in enzymology: the total material has more than doubled, and the complete 2nd edition consists of 39 volumes plus Synonym Index. Starting in 2009, all newly classified enzymes are treated in Supplement Volumes."

This book provides a compilation of the most up-to-date literature on the topic of immediate early genes (IEGs). It reviews and details experiments and theories that challenge the reader to expand their view on how IEG research is currently being used to advance our understanding of static and active brain circuits. In addition, the book explores roles of IEGs in clinical neuropathology.

Dynamic Treatment Regimes: Statistical Methods for Precision Medicine provides a comprehensive introduction to statistical methodology for the evaluation and discovery of dynamic treatment regimes from data. Researchers and graduate students in statistics, data science, and related quantitative disciplines with a background in probability and statistical inference and popular statistical modeling techniques will be prepared for further study of this rapidly evolving field. A dynamic treatment regime is a set of sequential decision rules, each corresponding to a key decision point in a disease or disorder process, where each rule takes as input patient information and returns the treatment option he or she should receive. Thus, a treatment regime formalizes how a clinician synthesizes patient information and selects treatments in practice. Treatment regimes are of obvious relevance to precision medicine, which involves tailoring treatment selection to patient characteristics in an evidence-based way. Of critical importance to precision medicine is estimation of an optimal treatment regime, one that, if used to select treatments for the patient population, would lead to the most beneficial outcome on average. Key methods for estimation of an optimal treatment regime from data are motivated and described in detail. A dedicated companion website presents full accounts of application of the methods using a comprehensive R package developed by the authors. The authors' website www.dtr-book.com includes updates, corrections, new papers, and links to useful websites.

In healthcare, the realisation of an optimistic prognosis against pessimistic ones depends on current innovations in diagnostic and cost-effective treatment approaches being widely adopted in clinical practice. Utilisation of advanced early and predictive diagnostics, targeted prevention and personalised medical approaches could enable the elderly subpopulation to reach the 100-year age limit in good physical and mental health, as actively contributing members of society. This task requires intelligent political regulations and creation of new guidelines to advance current healthcare systems. In this book, we will collect contributions from several geopolitical regions of Europe, Asia and USA that provide expert opinion on healthcare organisation and outlook as well as economical aspects of personalised medicine.

The overall themes of this book are recent advances in mechanisms of pain and the application of those in clinics. Specific attention is paid to developing countries where practice of pain management seriously lags behind current scientific understanding. Both the local traditions for curing pain and the substances used are presented in this book.

Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, particular for target therapy and immunotherapy in which time-to-event endpoints are often the primary endpoints. Most test statistics for single-arm phase II trial design with time-to-event endpoints are not available in commercial software. Key Features: Covers the most frequently used methods for single-arm phase II trial design with time-to-event endpoints in a comprehensive fashion. Provides new material on phase II immunotherapy trial design and phase II trial design with TTP ratio endpoint. Illustrates trial designs by real clinical trial examples Includes R code for all methods proposed in the book, enabling straightforward sample size calculation.

Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments. Such trials are widely used in clinical and medical research, and in other diverse areas such as veterinary science, psychology, sports science, and agriculture. The first edition of this book was the first to be wholly devoted to the subject. The second edition was revised to mirror growth and development in areas where the design remained in widespread use and new areas where it had grown in importance. This new Third Edition: Contains seven new chapters written in the form of short case studies that address re-estimating sample size when testing for average bioequivalence, fitting a nonlinear dose response function, estimating a dose to take forward from phase two to phase three, establishing proof of concept, and recalculating the sample size using conditional power Employs the R package Crossover, specially created to accompany the book and provide a graphical user interface for locating designs in a large catalog and for searching for new designs Includes updates regarding the use of period baselines and the analysis of data from very small trials Reflects the availability of new procedures in SAS, particularly proc glimmix Presents the SAS procedure proc mcmc as an alternative to WinBUGS for Bayesian analysis Complete with real data and downloadable SAS code, Design and Analysis of Cross-Over Trials, Third Edition provides a practical understanding of the latest methods along with the necessary tools for implementation.

This new volume looks at the applications of biomarkers as important tools for herbal drug discovery, presenting research on phytoconstituents with advanced nanotechnological applications for healthcare benefits. Herbal drug discovery based on biomarkers is an emerging area in complementary and alternative medicine that has tremendous potential in healthcare. Conventional medications have limited efficacy and high toxicity, whereas herbal drugs are said to provide wide structural diversity that is not usually seen with conventional/synthetic drug molecules. Recognition of various herbal constituents, such as terpenoids, fatty acids, flavonoids and steroids, are well explored in the management and treatment of various disorders in this volume. These agents target various biomarkers such as nitric oxide (NO), cytokines, chemokines, adhesion molecules, NF- k , lipoxygenase (LOX), and arachidonic acid. Biomarkers as Targeted Herbal Drug Discovery: A Pharmacological Approach to Nanomedicines discusses phytoconstituent-based nanotherapeutics with applications for some specific health issues, such as arthritis, leishmanicidal, cardiovascular diseases, cancer, ocular disorders, etc.

Signal Detection for Medical Scientists: Likelihood Ratio Based Test-Based Methodology presents the data mining techniques with focus on likelihood ratio test (LRT) based methods for signal detection. It emphasizes computational aspect of LRT methodology and is pertinent for first-time researchers and graduate students venturing into this interesting field. The book is written as a reference book for professionals in pharmaceutical industry, manufactures of medical devices, and regulatory agencies. The book deals with the signal detection in drug/device evaluation, which is important in the post-market evaluation of medical products, and in the pre-market signal detection during clinical trials for monitoring procedures. It should also appeal to academic researchers, and faculty members in mathematics, statistics, biostatistics, data science, pharmacology, engineering, epidemiology, and public health. Therefore, this book is well suited for both research and teaching. Key Features: Includes a balanced discussion of art of data structure, issues in signal detection, statistical methods and analytics, and implementation of the methods. Provides a comprehensive summary of the LRT methods for signal detection including the basic theory and extensions for varying datasets that may be large post-market data or pre-market clinical trial data. Contains details of scientific background, statistical methods, and associated algorithms that a reader can quickly master the materials and apply methods in the book on one's own problems

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

This book discusses the why and how of each step of data-based medical research that can provide basic information to emerging researchers and medical graduate students who write theses or publish articles. The chapters are arranged in the sequence of steps for data-based research. The research steps are comprehensively covered from the selection of the topic to the final publication. Reporting methods such as CONSORT, STARD, and SAMPL guidelines are also covered. Each chapter has separately earmarked examples from the contemporary literature that illustrate the different research methods. Key Features Discusses all the steps of data-based medical research Examines the topics in depth by way of examples from contemporary literature Features notable information in boxes for special attention .

"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.

Medicinal Plants in the Asia Pacific for Zoonotic Pandemics provides an unprecedented, comprehensive overview of the phylogeny, botany, ethnopharmacology, and pharmacology of more than 100 plants used in the traditional medical systems of Asia and Pacific. It discusses their actions and potentials against viruses, bacteria, and fungi that represent a threat of epidemic and pandemic diseases, with an emphasis on the molecular basis and cellular pathways. This book presents scientific names, the botanical classification, traditional medicinal uses, active chemical constituents, and pharmacology. This volume is a critical reference for anyone involved in the discovery of lead molecules or phytopharmaceutical products for the prevention or treatment of pandemic viral, bacterial, or fungal infections. FEATURES Phylogenetic presentation of medicinal plants and a chemotaxonomical rationale of antiviral, antibacterial, and antifungal actions Discusses the chemical structure-activity relationship, pharmacokinetics, and oral bioavailability of antimicrobial principles Introduces the molecular mechanism of natural products on viruses, bacteria, and fungi Contains a selection of botanical plates and useful bibliographic references This book is a useful research tool for postgraduates, academics, and the pharmaceutical, herbal, and nutrition industries. Medicinal Plants in the Asia Pacific for Zoonotic Pandemics includes commentary sections that invite further research and reflection on the fascinating and timely subject of the development of drugs and herbals from Asia-Pacific medicinal plants to safeguard humanity and other life forms against the forthcoming waves of viral, bacterial, or fungal pandemics. This book is an ideal reference text for medicinal plant enthusiasts.

Medicinal Plants in the Asia Pacific for Zoonotic Pandemics provides an unprecedented, comprehensive overview of the phylogeny, botany, ethnopharmacology, and pharmacology of more than 100 plants used in the traditional medical systems of Asia and Pacific. It discusses their actions and potentials against viruses, bacteria, and fungi that represent a threat of epidemic and pandemic diseases, with an emphasis on the molecular basis and cellular pathways. This book presents scientific names, the botanical classification, traditional medicinal uses, active chemical constituents, and pharmacology. This volume is a critical reference for anyone involved in the discovery of lead molecules or phytopharmaceutical products for the prevention or treatment of pandemic viral, bacterial, or fungal infections. FEATURES Phylogenetic presentation of medicinal plants and a chemotaxonomical rationale of antiviral, antibacterial, and antifungal actions Discusses the chemical structure-activity relationship, pharmacokinetics, and oral bioavailability of antimicrobial principles Introduces the molecular mechanism of natural products on viruses, bacteria, and fungi Contains a selection of botanical plates and useful bibliographic references This book is a useful research tool for postgraduates, academics, and the pharmaceutical, herbal, and nutrition industries. Medicinal Plants in the Asia Pacific for Zoonotic Pandemics includes commentary sections that invite further research and reflection on the fascinating and timely subject of the development of drugs and herbals from Asia-Pacific medicinal plants to safeguard humanity and other life forms against the forthcoming waves of viral, bacterial, or fungal pandemics. This book is an ideal reference text for medicinal plant enthusiasts.

The drug discovery and development process is getting longer, more expensive, and no better. The industry suffers from the same clinical attrition and safety-related market withdrawal rates today as it did 20 years ago. Industrialization of Drug Discovery: From Target Selection Through Lead Optimization scrutinizes these problems in detail, contrasting the promise of technology and industrialization with the challenges of using the tools available to their best advantage. The book explores early successes, examines the current state of the art, and provides a strategic analysis of the issues currently facing drug discovery. Introducing the historical background and current status of the industry, the book delineates the basic tenets underlying modern drug discovery, how they have evolved, and their use in various approaches and strategies. It examines, in detail, the regulations, requirements, guidelines, and draft documents that guide so many FDA actions. The editor devotes the remainder of the discussion to industrialization, compound and knowledge management functions, the drug screening process, collaboration, and finally, ethical issues. Drawing on real-life, from-the-trenches examples, the book elucidates a new approach to drug discovery and development. This modern-day, back-to-basics approach includes three steps: understand the science, unravel the story, and then intelligently apply the technology, bringing to bear the entire armamentarium of industrialization techniques, not just automation, to the discovery process. Using these steps, you can meet the goals of more specific targets, more selective compounds, and decreased cycle times. In effect, you can look for a bigger needle in a smaller haystack. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.

This volume contains several reviews in the field as well as the step-by-step use of targeted and global approaches within the areas of genomics, epigenetics, proteomics, transcriptomics and metabolomics which aim to address this dilemma and to help pinpoint new treatment strategies. Chapters detail the generation of several models and methods for assessing health and provide researchers potential approaches for reversing or minimizing effects of disease. In addition, important information on disease mechanisms is provided, as each method is described in the context of a specific disease or therapeutic area. Written in the highly successful Methods in Molecular Biology series format, the chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Investigations of Early Nutrition Effects on Long-Term Health: Methods and Applications aim is to provide insights into the latest ideas and technologies .enabling progress in this field.

Intellectual Property and Health Technologies

Balancing Innovation and the Public's Health

Joanna T. Brougher, Esq., MPH

At first glance, ownership of intellectual property seems straightforward: the control over an invention or idea. But with the recent explosion of new scientific discoveries poised to transform public health and healthcare systems, costly and lengthy patent disputes threaten both to undermine the attempts to develop new medical technologies and to keep potentially life-saving treatments from patients who need them.

"Intellectual Property and Health Technologies" grounds readers in patent law and explores how scientific research and enterprise are evolving in response. Geared specifically to the medical disciplines, it differentiates among forms of legal protection for inventors such as copyrights and patents, explains their limits, and argues for balance between competing forces of exclusivity and availability. Chapters delve into the major legal controversies concerning medical and biotechnologies in terms of pricing, markets, and especially the tension between innovation and access, including:

The patent-eligibility of genesThe patent-eligibility of medical process patentsThe rights and roles of universities and inventorsThe balancing of access, innovation, and profit in drug developmentThe tension between biologics, small-molecule drugs, and their generic counterpartsInternational patent law and access to medicine in the developing world

As these issues continue to shape and define the debate, "Intellectual Property and Health Technologies" enables professionals and graduate students in public health, health policy, healthcare administration, and medicine to understand patent law and how it affects the development of medical technology and the delivery of medicine. "

Learn how to evaluate and apply health sciences research with this beginner's guide! Reading Research: A User-Friendly Guide for Health Professionals, 7th Edition provides a clear introduction to reading and understanding research articles, with practical guidelines for implementing research into clinical practice. It describes how to interpret common research methods including qualitative, quantitative and mixed-method approaches, and explains how to find relevant, reliable research on the internet. Written by Barbara Davies and Jo Logan, both of whom are noted educators and research experts, this easy-to-use pocket guide is ideal for both students and health professionals. Concise overview of health sciences-related research maximizes your study time and makes it easier to understand qualitative, quantitative, and mixed-methods research. Succinct introduction to reading and understanding health sciences research articles is accompanied by practice worksheets and other learning resources on an Evolve website. Helpful guidelines suggest how to find interesting research results, identify how to use research results towards planning and delivering best practices and improving patient outcomes, and recommend actions to address barriers to using research in practice. UNIQUE! Tips boxes provide practical, easy-to-follow advice for those who are new to the subject. UNIQUE! Alert! boxes warn of common assumptions made when reading research. Recommendations for best practices in research include brief definitions of popular research terms as well as links to World Health Organization information, the latest RNAO (Registered Nurses' Association of Ontario) Best Practice Guidelines, and guidelines from Australia, the USA, the UK, and other countries. NEW! Enhanced worksheet exercises on the Evolve website demonstrate how to apply knowledge gained from the text, based on research articles drawn from Australia, Canada, Europe, and the USA, on a variety of health issues encountered in hospital and community settings.

In collaboration with the Breast Cancer Research Foundation (BCRF), this timely volume provides a comprehensive review on all areas of breast cancer survivorship research, highlighting research that is underway or in development. The range of topics covered include the biology and management of fatigue and cognitive dysfunction on breast cancer survivorship, the biology and management of Neuropathy and Arthralgias, the ongoing research on the biology of diet and lifestyle interventions in survivors, and more. With the tremendous growth in the number of breast cancer survivors, researchers have moved beyond describing the outcomes of breast cancer treatments and are focusing their research on understanding the mechanisms underlying the development of the late effects of breast cancer treatment, as well as the development and evaluation of interventions to mitigate some of the persistent symptoms-topics which are also explored in this volume. In addition, current research on how to improve survivorship and reduce recurrence of breast cancer through behavioral and lifestyle modifications is also discussed.