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 botanical plates and useful bibliographic references A useful research tool for postgraduates, academics, and the pharmaceutical, herbal, or nutrition industries.

The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using accessible language, providing technical details, real-world examples, and SAS and R code to implement analyses. The updated ICH guideline raises new analytic and cross-functional challenges for statisticians. Gaps between different communities have come to surface, such as between causal inference and clinical trialists, as well as among clinicians, statisticians, and regulators when it comes to communicating decision-making objectives, assumptions, and interpretations of evidence. This book lays out a path toward bridging some of these gaps. It offers ? A common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges ? A thorough treatment of intercurrent events (ICEs), i.e., postrandomization events that confound interpretation of outcomes and five strategies for ICEs in ICH E9 (R1) ? Details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs: ? A perspective on the role of the intention-to-treat principle ? Examples and case studies from various areas ? Example code in SAS and R ? A connection with causal inference ? Implications and methods for analysis of longitudinal trials with missing data Together, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial and academic perspective.

For more than a century, bioactive heterocycles have formed one of the largest areas of research in organic chemistry. They are important from a biological and industrial point of view as well as to the understanding of life processes and efforts to improve the quality of life. Heterogeneous Catalysis: A Versatile Tool for the Synthesis of Bioactive Heterocycles highlights the recent methodologies used in the synthesis of such bioactive systems and focuses on the role of heterogeneous catalysis in the design and synthesis of various biologically active heterocyclic compounds of pharmacological interest. Topics include: Synthetic protocols for the construction of heterocyclic systems employing silica-bound catalysts Recent advances in heterogeneous copper-catalyzed reactions for the synthesis of bioactive heterocycles Features of silica-based heterogeneous catalysts, such as abundance, ease of use, and stability Ultrasound as an effective tool for accelerating reactions Organic transformations catalyzed by nano-ZnO as a valuable heterogeneous catalyst Heterogeneous catalysts employed in the synthesis of coumarins Heterocyclizations in the presence of silver salts Home-made organometallic silica sources, known as silatranes Reflecting the focused studies currently conducted in these areas, the book also examines anticancer, antifungal, antibacterial, anti-HIV, anti-inflammatory, antioxidant, and many more biological activities of heterocyclic compounds. It is essential reading for postgraduate and research scholars in the fields of biochemistry, chemical biology, medicinal chemistry and pharmaceutical chemistry.

This book is devoted to the problems of oxidation chemical reactions and addresses bimodal reaction sequences. Chemical reactions of oxidation, occurring under certain conditions and in multicomponent systems are complex processes. The process of the oxidation essentially changes in the presence and contact of the solid substances with reactants. The role of solid substances and the appearance of this phenomenon in oxidation reaction are discussed. The reader will understand the "driving forces" of this phenomenon and apply it in practice. Written for chemists, physicists, biologists and engineers working in the domain of oxidation reactions. Key Selling Features: Covers the historical background, modern state of the art, and perspectives in investigations of the coupling between heterogeneous and homogeneous reactions Discusses the feasible pathways of the coupling of heterogeneous and homogeneous reactions in oxidation in man-made and natural chemical systems Addresses the abundance, peculiarities and mechanisms of the bimodal reaction sequences in oxidation with dioxygen in recent decades Discusses the existence of the bimodal reaction sequences in chemical systems investigations in atmospheric chemistry and heterogeneous photocatalysis Presented in a simple concise style, accessible for both specialists and non-specialists

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.

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. "

Coherent treatment of a variety of approaches to multiple comparisons Broad coverage of topics, with contributions by internationally leading experts Detailed treatment of applications in medicine and life sciences Suitable for researchers, lecturers / students, and practitioners

In these uncertain times, how much can you trust health news? Is the research behind breaking headlines reliable? This book is an indispensable resource for students and general readers, helping them evaluate and think critically about health information. "People Who Drink Coffee Live Longer." "Students Learn Better When Listening to Classical Music." "Scientists Discover the Gene That Causes Obesity." We are constantly bombarded with reports of "groundbreaking" health findings that use attention-grabbing headlines and seem to be backed by credible science. Yet many of these studies and the news articles that discuss them fall prey to a variety of problems that can produce misleading and inaccurate results. Some of these may be easy to notice-like a research study on the benefits of red meat funded by the beef industry, or a study with a sample size of only 10 people-but others are much harder to spot. Skewed Studies: Exploring the Limits and Flaws of Health and Psychology Research examines the most pervasive problems plaguing health research and reporting today, using clear, accessible language and employing real-world examples to illustrate key concepts. Beyond simply outlining issues, it provides readers with the knowledge and skills to evaluate research studies and news reports for themselves, improving their health literacy and critical thinking skills. Brings together and thoroughly explores the many ways in which health research and reporting can be flawed and problematic Improves readers' critical thinking skills and gives them practical tools to better evaluate the health information they come across Explains scientific and statistical concepts in clear, easy-to-understand language Includes a curated and annotated directory of resources for readers seeking additional information

Drug Discovery with Privileged Building Blocks traces back PharmaBlock's founding philosophy of designing privileged building blocks. High-quality building blocks are crucial not only to biological activities of different molecules but also to ADMET properties, which eventually will impact the success rate of drug discovery projects. A thorough study of how building blocks perform in drug molecules and a regular analysis of new building block structures in the latest researches have proven to be a fruitful strategy to generate novel building blocks. Using this strategy, PharmaBlock has supplied the drug industry with a great number of building blocks, which are increasingly being adopted by drug hunters, and these are identified in this book. Each chapter may be read and studied without learning the previous chapters. This book will be a good starting point for novice medicinal chemists, and veteran medicinal chemists will find it useful as well. Key Feature The book covers privileged building blocks appearing most frequently on patents for novel drugs. The latest relevant tactics are explained in the context of drug design and medicinal chemistry. Key synthesis, especially large-scale synthesis, is described. The most recent literature references are cited.

Drug Discovery with Privileged Building Blocks traces back PharmaBlock's founding philosophy of designing privileged building blocks. High-quality building blocks are crucial not only to biological activities of different molecules but also to ADMET properties, which eventually will impact the success rate of drug discovery projects. A thorough study of how building blocks perform in drug molecules and a regular analysis of new building block structures in the latest researches have proven to be a fruitful strategy to generate novel building blocks. Using this strategy, PharmaBlock has supplied the drug industry with a great number of building blocks, which are increasingly being adopted by drug hunters, and these are identified in this book. Each chapter may be read and studied without learning the previous chapters. This book will be a good starting point for novice medicinal chemists, and veteran medicinal chemists will find it useful as well. Key Feature The book covers privileged building blocks appearing most frequently on patents for novel drugs. The latest relevant tactics are explained in the context of drug design and medicinal chemistry. Key synthesis, especially large-scale synthesis, is described. The most recent literature references are cited.

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.

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.

Aggregates of the TAR DNA binding protein 43 (TDP-43), are hallmark features of the neurodegenerative diseases Amyotrophic Lateral Sclerosis (ALS) and frontotemporal dementia (FTD), with overlapping clinical, genetic and pathological features. TDP-43 and Neurodegeneration: From Bench to Bedside summarizes new findings in TDP-43 pathobiology and proteinopathies. The book summarizes TDP-43's structure, function, biology, misfolding, aggregation, pathogenesis and therapeutics. It includes autophagy-mediated therapy, role of stress granule, novel genetic, cell culture-based models, systems biology for precision medicine, development of stem cells and mechanism-based therapies that can target ALS and other related neurodegenerative diseases. This book is written for neuroscientists, neurologists, clinicians, advanced graduate students, drug discovery researchers, as well as cellular and molecular biologists involved in ALS, motor neuron disease (MND) and other neurodegenerative disorders.

This book presents a road map for applying the stages in conceptualization, evaluation, and testing of biomedical devices in a systematic order of approach, leading to solutions for medical problems within a well-deserved safety limit. The issues discussed will pave the way for understanding the preliminary concepts used in modern biomedical device engineering, which include medical imaging, computational fluid dynamics, finite element analysis, particle image velocimetry, and rapid prototyping. This book would undoubtedly be of use to biomedical engineers, medical doctors, radiologists, and any other professionals related to the research and development of devices for health care.

Angiogenesis and lymphangiogenesis have become attractive targets for drug therapy because of their key roles in a broad spectrum of pathological disease states ranging from macular degeneration to tumor growth and metastasis. A substantial increase in the research effort over the past decade has deepened our understanding of the basic mechanisms underlying angiogenesis and lymphangiogenesis, promoting the development of promising therapeutics for the clinical management of vascular-related diseases. These extraordinary advancements have been built upon a vast array of diverse analytical techniques developed globally throughout the field. Over the years, these methods have evolved to suit the specific needs of different researchers and experimental scenarios, resulting in a myriad of technical variants of basic assay approaches.

"The Textbook of Angiogenesis and Lymphangiogenesis: Methods and Applications" is an up-to-date comprehensive textbook on angiogenesis and lymphangiogenesis techniques and applications. This volume is designed to embody the collective works of experts in the clinical as well as the basic research arenas who have significantly contributed to the development and application of techniques in all areas of angiogenesis and lymphangiogenesis. Each chapter introduces and discusses one or a group of closely related techniques and convey step-by-step protocol information and detailed technical guidance to the reader. Emphasis has been placed on explanatory illustrations, critical technical steps as well as divulging information on the benefits and caveats of specific practices related to the methods discussed. This manual is intended to serve as a written guide for both newcomers and established professionals in the field.

An odd and unexpected finding was reported by the laboratory of Richard Jorgensen in 1990: expression of extra copies of the gene encoding chalone synthase in petunias turned off the endogenous chalone synthase gene. An observation that appeared totally unrelated was made by the laboratory of Victor Ambrose in 1993: a gene in Caenorhabditis elegans, lin-4, controlled the timing of larval development but did not encode a protein. Rather, it expressed two small RNAs that were complementary to the 3'-untranslated region of the lin-14 gene in a region that had previously been shown to repress expression of the LIN-14 protein. From another quarter, David Baulcombe's laboratory showed in 1997 that plant viruses could induce sequen- specific gene silencing. Then in a landmark paper, Andrew Fire and Craig Mello showed in 1998 that double-stranded RNA (dsRNA) triggers a gene-silencing mechanism that they dubbed RNA interference (RNAi), for which discovery they were awarded the Nobel Prize in Physiology or Medicine in 2006. These diverse findings have triggered an explosion of research around the world in both plants and animals to discover the mechanisms and broader ramifications of RNAi. We now know that there are both exogenous pathways involving formation of siRNA when dsRNA is introduced and endogenous pathways involving miRNA, piwiRNA, and rasiRNAs. All pathways culminate in formation of an RNA-induced silencing complex (RISC) containing a member of the Argonaute protein family bound to a 22-nt RNA strand that interacts with a target mRNA or gene through Watson-Crick base pairing.

Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval. Key Features: Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA's current guidelines. Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability. Discusses the feasibility and validity of the non-medical switch studies. Provides innovative thinking for detection of possible reference product change over time. This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions.

Cancer research is at a crossroads. Traditionally, cancer has been thought of as a disease of gene mutation, where the stepwise accumulation of cancer gene mutations is the key, and the identification of common gene mutations has been considered to be essential for diagnosis and treatment. Despite extensive research efforts and accumulated knowledge on cancer genes and pathways, the clinical benefits of this traditional approach have been limited. Recently, cancer genome sequencing has revealed an extensive amount of genetic heterogeneity where the long-expected common mutation drivers have been difficult, if not impossible, to identify. These realities ultimately challenge the conceptual framework of current cancer biology.This book introduces a new concept of genome theory of cancer evolution, in an attempt to unify the field. Many important and representative, but often confusing, questions and paradoxes are critically analyzed. By comparing gene- and genome-based theories, the hidden flaws of many popular viewpoints are addressed. This discussion is intended to initiate a much-needed critical re-evaluation of current cancer research.

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.

PREFACE The Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture is involved in agricultural research and development and assists Member States of FAO and IAEA in improving strategies to ensure food security through the use of nuclear techniques and related biotechnologies, where such techniques have a valuable and often unique role. In particular, molecular diagnostic methods have rapidly evolved in the past twenty years, since the advent of the Polymerase Chain Reaction (PCR). They are used in a wide range of agricultural areas such as, improving soil and water management; producing better crop varieties; diagnosing plant and animal diseases; controlling insect pests and improving food quality and safety. The uses of nucleic acid-directed methods have increased significantly in the past five years and have made important contributions to disease control country programmes for improving national and international trade. These developments include the more routine use of PCR as a diagnostic tool in veterinary diagnostic laboratories. However, there are many problems associated with the transfer and particularly, the application of this technology. These include lack of consideration of: the establishment of quality-assured procedures, the required set-up of the laboratory and the proper training of staff. This can lead to a situation where results are not assured. This book gives a comprehensive account of the practical aspects of PCR and strong consideration is given to ensure its optimal use in a laboratory environment. This includes the setting-up of a PCR laboratory; Good Laboratory Practice and standardised of PCR protocols.

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.

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.

This new book, Plant- and Marine- Based Phytochemicals for Human Health: Attributes, Potential, and Use, provides insight with scientific evidence on the use of medicinal plants in the treatment of certain diseases. It describes bioactive compounds of marine and plant origin that have been discovered to be advantageous for human health, shedding new light on the potential of phytochemicals on human health and contributing to the ocean of knowledge on phytochemistry and pharmaceutical biology. In addition, the role of plant-based pharmaceuticals is also discussed as an example of innovative uses of plant product. This book addresses the importance of phytochemicals from plants and marine life. It divided in four parts: Bioactive compounds in medicinal plants: status and potential Plant-based pharmaceuticals in human health: review Therapeutic attributes of mushroom, cereal grains, and legumes Innovative use of medicinal plants This compendium will be useful for the students and researchers as well as for industry professionals working in the food, nutraceuticals, and herbal industries.

This volume provides an integrated account of our current understanding of the functions of D-type cyclins during development and tumorigenesis, with special emphasis on the kinase-independent functions of these proteins. The volume will provide a thorough review of the latest discoveries on the new functions and interacting partners of mammalian cyclin Ds crucial to explain their oncogenic and differentiation properties in different cellular contexts. The volume begins with a historical perspective of how D-type cyclins were first discovered and eventually cloned from cancer tissues, followed by an account on the canonical functions of cyclin Ds during the G1-S transition of the cell cycle. Several chapters will be devoted to review the functions of D-type cyclins as transcriptional regulators and the mechanisms through which these novel functions could impact the tumorigenic process. Also discussed is emerging evidence that points to a role of D-type cyclins, particularly cyclin D1, as a cytoplasmic regulator of various cellular functions. This property, in human cells at least, is traceable to certain splice isoforms with novel oncogenic implications. Finally, a chapter is devoted to recent efforts to revise the canonical view of the "retinoblastoma pathway" to incorporate new evidence that suggests that cyclin D1's role in G1 is to singly-phosphorylate the retinoblastoma protein (pRb) for discrimination of target protein interactions. This work represents a significant departure from the view of cyclin D1 as a negative regulator of pRb and may have critical implications for understanding the function of antineoplastic agents that target the cyclin D1-associated kinases.