Dressings for Advanced Wound Care focuses on helping the reader better understand advanced wound care and relevant technologies. It explains how different types of wounds may require different environments to heal and how dressings can help in creating the right environment. It gives an overview of the various dressing technologies that are available to help manage wounds that are difficult to heal. Finally, this book highlights the current trends that may be directing the future of the advanced wound dressing sector. FEATURES: Relates technologies with commercially available end-products, giving the reader a more specific overview of the advanced wound dressing sector Provides a realistic overview of the process of developing an advanced wound care dressing Summarises recent clinical evidence on advanced wound dressings Explains how dressings differ and what works best for which wound type Examines clinical evidence on technologies and on-market products Describes the requirements for launching a new advanced wound dressing This book is aimed at medical clinicians and professionals in the fields of biomedical engineering, textile science, and materials engineering.

This book details the advances in drug discovery and delivery and the present need for emerging technologies. Throughout the text new micro and nanofabrication techniques are described, including methods like electrohydrodynamic processes, additive manufacturing, and microfluidics, which have the potential to produce drug delivery systems that were not possible a few years ago. This book is of great use to both entry-level and experienced researchers in the field of emerging technologies for the manufacturing of drug delivery devices.

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.

"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.

This third edition presents and dissects a wide variety of HIT failures so that the reader can understand in each case what went wrong and why and how to avoid such problems, without focusing on the involvement of specific people, organizations, or vendors. The lessons may be applied to future and existing projects, or used to understand why a previous project failed. The reader also learns how common causes of failure affect different kinds of HIT projects and with different results. Cases are organized by the type of focus (hospital care, ambulatory care, and community). Each case provides analysis by an author who was involved in the project plus the insight of an HIT expert. This book presents a model to discuss HIT failures in a safe and protected manner, providing an opportunity to focus on the lessons offered by a failed initiative as opposed to worrying about potential retribution for exposing a project as having failed. Access expert insight into key obstacles that must be overcome to leverage IT and transform healthcare. Each de-identified case study includes an analysis by a group of industry experts along with a counter analysis. Cases include a list of key words and are categorized by project (e.g. CPOE, business intelligence). Each case study concludes with a lesson learned section. Thought provoking commentary chapters add additional context to the challenges faced during HIT projects, from social and organizational to legal and contractual.

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.

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

Originally published in 1997 Evolutionary Change addresses the somatic mechanism of change. Although astounding advances in molecular biology have opened up new engineering possibilities to shape our future in terms of "improving" the human species as well as eradicating all kinds of pathological characteristics of biological development, these possibilities pose potentially serious dangers. They arise primarily from the local nature of changes that are introduced and the impact of the environment on the overall development of the biological system. The book explores the biological mechanisms of change in their entirety - as they fit into the general dynamics of biological systems - and demonstrates the pitfalls of tackling change from a narrow perspective, using cancer as an example of certain pathological manifestations of these mechanisms of change.

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 book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition. Key Features: Continues to be the definitive reference on drug metabolism Covers the drug transporter field, disposition of protein therapeutics and metabolic activation of drugs Includes the contributions of world-class experts in their respective fields Contains the work of editors who are recognized leaders and deep content experts in the field of drug metabolism Emphasizes new scientific and regulatory developments in the field

Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. The first section of the book provides background information about clinical trials. It defines and compares clinical trials to other types of research studies and discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. It also includes a special chapter outlining the valuable attributes that statisticians can develop to maximize their contributions to a clinical trial. The second section examines scientific issues faced in each progressive step of a clinical trial. It covers issues in trial design, such as randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority, and parallel group versus crossover designs; data monitoring; analyses of efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial results. As clinical trials remain the gold standard research studies for evaluating the effects of a medical intervention, newcomers to the field must have a fundamental understanding of the concepts to tackle real-world issues in all stages of trials. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.

Cancer is a major healthcare burden across the world and impacts not only the people diagnosed with various cancers but also their families, carers, and healthcare systems. With advances in the diagnosis and treatment, more people are diagnosed early and receive treatments for a disease where few treatments options were previously available. As a result, the survival of patients with cancer has steadily improved and, in most cases, patients who are not cured may receive multiple lines of treatment, often with financial consequences for the patients, insurers and healthcare systems. Although many books exist that address economic evaluation, Economic Evaluation of Cancer Drugs using Clinical Trial and Real World Data is the first unified text that specifically addresses the economic evaluation of cancer drugs. The authors discuss how to perform cost-effectiveness analyses while emphasising the strategic importance of designing cost-effectiveness into cancer trials and building robust economic evaluation models that have a higher chance of reimbursement if truly cost-effective. They cover the use of real-world data using cancer registries and discuss how such data can support or complement clinical trials with limited follow up. Lessons learned from failed reimbursement attempts, factors predictive of successful reimbursement and the different payer requirements across major countries including US, Australia, Canada, UK, Germany, France and Italy are also discussed. The book includes many detailed practical examples, case studies and thought-provoking exercises for use in classroom and seminar discussions. Iftekhar Khan is a medical statistician and health economist and a lead statistician at Oxford Unviersity's Center for Statistics in Medicine. Professor Khan is also a Senior Research Fellow in Health Economics at University of Warwick and is a Senior Statistical Assessor within the Licensing Division of the UK Medicine and Health Regulation Agency. Ralph Crott is a former professor in Pharmacoeconomics at the University of Montreal in Quebec, Canada and former head of the EORTC Health Economics Unit and former senior health economist at the Belgian HTA organization. Zahid Bashir has over twelve years experience working in the pharmaceutical industry in medical affairs and oncology drug development where he is involved in the design and execution of oncology clinical trials and development of reimbursement dossiers for HTA submission.

The field of industrial microbiology involves a thorough knowledge of the microbial physiology behind the processes in the large-scale, profit-oriented production of microbe-related goods which are the subject of the field. In recent times a paradigm shift has occurred, and a molecular understanding of the various processes by which plants, animals and microorganisms are manipulated is now central to industrial microbiology. Thus the various applications of industrial microbiology are covered broadly, with emphasis on the physiological and genomic principles behind these applications. Relevance of the new elements such as bioinformatics, genomics, proteomics, site-directed mutation and metabolic engineering, which have necessitated the paradigm shift in industrial microbiology are discussed.

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

This new volume, Promising Drug Molecules of Natural Origin, explores potential beneficial drug substances derived from nature. It presents the general principles, characteristics, evaluation techniques, and applications involved in drug molecules from natural sources, such as plants and marine life. With chapters from renowned experts from around the world, the chapters in this volume address the challenges of standardization of herbal medicines, methods of characterization of natural medicines and phyto-constituents, and quality control methods for herbal medicines. Several chapters in the book focus on the evolution of phyto-constituents in cancer therapeutics, while others deal with applications for other diseases, such as diabetes and neuroinflammatory disorders. The volume also specifically reviews heterocyclic drugs from plants. This volume will be a valuable resource for faculty and advanced students in pharmaceutics as well as researchers, scientists, and industry professionals in medicine and drug development.

This book provides a link between different disciplines of nanophysics, biophotonics, nanobiomaterials & applications of nanobiophotonics in biomedical research and engineering. The fundamentals of light, matter, nanobiomaterials & nanophysics are discussed together, and relevant applications in biomedical engineering as well as other related factors influencing the interaction process are explicated. Theoretical and experimental research is combined, emphasizing the influence of crucial common factors on applications.

The 9th International Conference on Bioinformatics and Biomedical Engineering (iCBBE 2015) was held on September 18-20, 2015, Shanghai, China. This proceedings volume assembles papers from various professionals engaged in the fields of Biomedical Engineering, Bioinformatics and Computational Biology. The conference had special sessions on biomedical imaging, biostatistics and biometry, information technology in bioinformatics and environmental pollution & public health.

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.

There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book's website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others

Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient's rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry's key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive's perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.

"The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings's College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

Efficient mobile systems that allow for vital sign monitoring and disease diagnosis at the point of care can help combat issues such as rising healthcare costs, treatment delays in remote and resource-poor areas, and the global shortage of skilled medical personnel. Covering everything from sensors, systems, and software to integration, usability, and regulatory challenges, Mobile Point-of-Care Monitors and Diagnostic Device Design offers valuable insight into state-of-the-art technologies, research, and methods for designing personal diagnostic and ambulatory healthcare devices. Presenting the combined expertise of contributors from various fields, this multidisciplinary text: Gives an overview of the latest mobile health and point-of-care technologies Discusses portable diagnostics devices and sensors, including mobile-phone-based health systems Explores lab-on-chip systems as well as energy-efficient solutions for mobile point-of-care monitors Addresses computer vision and signal processing for real-time diagnostics Considers interface design for lay healthcare providers and home users Mobile Point-of-Care Monitors and Diagnostic Device Design provides important background information about the design process of mobile health and point-of-care devices, using practical examples to illustrate key aspects related to instrumentation, information processing, and implementation.

Organic chemistry research has moved rapidly toward synthesis and medicinal application of nitrogen-containing compounds such as triazenes, triazines, and hydroxytriazenes due to their excellent biological activities. Many of them are presently in clinical trials. Triazene compounds have excellent medicinal properties and limited toxicity. Hydroxytriazenes are excellent chelating agents for transition metals. Newer studies show very promising biological and medicinal applications of these classes of compounds. Hydroxytriazenes and Triazenes: The Versatile Framework, Synthesis, and Medicinal Applications highlights synthetic methods, recent advances, and potential applications of triazines, triazenes, and hydroxytriazenes. This book includes holistic information on synthetic methods for novel compounds based on this moiety, up-to-date information on the how and why of their diverse or even multitargeted medicinal application, and future state of the art of both aspects. Other features include: Highlights recent advances and diverse possible applications of biological functions Covers the chemistry of triazine, triazene, and hydroxytriazene systems On the basis of in silico predictions, the book highlights synthetic methods and their applications A valuable source of information for those actively engaged in medicinal chemistry, drug discovery, and synthetic organic chemistry

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors' decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.