Health care is one of today's most discussed and debated topics. From issues such as accessibility to costs to quality, the debates range widely among doctors, patients, employers, and insurers. A popular topic in political campaigns and the media, health care and health care management is also a quiet and unremitting concern in the private and personal lives of individuals who worry about someday having to choose between food and prescription drugs.

For this reason, in today's health care industry, good business practices may be as important as the practice of medicine in assuring the continued health of the industry.

The Encyclopedia of Health Care Management will prove invaluable to libraries serving students and professionals in health and business. It will also be an essential reference for physicians, providers and their employees, and students and professors in health and management for responsible and successful practice and administration in the health care industry.

This encyclopedia is the most comprehensive reference work on the business of health care, with up-to-date information across a broad range of issues affecting every aspect of the industry and the people it serves, employs, and influences.

• The most comprehensive reference work on health care management
• Broad range of timely topics, spanning academic, corporate and governmental arenas
• Over 600 entries
• More than 160 expert contributors in the fields of medicine, public health, and business
• Tables on
  • Health Care Acronyms
  • Medical Degrees
  • Medical Legislation
  • Medical Organizations
  • Medical Specialties

Michael J. Stahl, Ph.D. is Director of the Physician Executive MBA Program and Distinguished Professor of Management in the College of Business at the University of Tennessee, Knoxville. Dr. Stahl received his B.S. in Electrical Engineering from the State University of NY at Buffalo and his Ph.D. in Management from Rensselaer Polytechnic Institute. From 1982-1989, Stahl was Head of the Management Department at Clemson University He was Associate Dean in the College of Business at the University of Tennessee from 1989-1997. Dr. Stahl has published over 50 journal articles in a variety of areas including Strategic Management, TQ, and healthcare, as well as twelve books including Strategic Management, Perspectives in TQ, and The Physician's Essential MBA. He teaches strategy and business planning in the Physician EMBA, Taiwan EMBA, and MBA Programs.

Academic, Public, Special, Private/Corporate

This comprehensive text examines both global and local coronary blood flow based on morphometry and mechanical properties of the coronary vasculature. Using a biomechanical approach, this book addresses coronary circulation in a quantitative manner based on models rooted in experimental data that account for the various physical determinants of coronary blood flow including myocardial-vessel interactions and various mechanisms of autoregulation. This is the first text dedicated to a distributive analysis (as opposed to lumped) and provides digital files for detailed anatomical data (e.g., diameters, lengths, node-to-node connections) of the coronary vessels. This book also provides appendices with specific mathematical formulations for the biomechanical analyses and models in the text. Written by Dr. Ghassan S. Kassab, a leader in the field of coronary biomechanics, Coronary Circulation: Anatomy, Mechanical Properties, and Biomechanics is a synthesis of seminal topics in the field and is intended for clinicians, bioengineers, and researchers as a compendium on the topic. The detailed anatomical and mechanical data provided are intended to be used as a platform to address new questions in this exciting and clinically very important research area.

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.

The newer research areas in pharmaceutical sciences, particularly molecular modeling and simulations, prompted a more efficient drug discovery process. Informatics integrated with pharmaceutical sciences (cheminformatics and bioinformatics) became an essential component of drug research. Drug informatics such as genomics and proteomics assists in the Rational Drug Design (RDD). This emerging discipline is known as "Computer-Aided Drug Design" (CADD), which has profound application in RDD. The advanced and adequate practice in drug design informatics is essential for pharmacy graduates. Hence, a companion for acquiring knowledge on these concepts is vital. The students of B. Pharmacy, M. Pharmacy (Pharmaceutical Chemistry, Pharmacology, and Pharmaceutics), biotechnology, biomedical engineering and other interdisciplinary fields may find this book as a reference guide. The salient features of this book are: * Systematic and simple approach * Emphasis on traditional and modern drug design strategies * Comprehensive coverage for the current advances in the drug design * Experimental section to ensure hands-on-experience Note: T& F does not sell or distribute the Hardback in India, Pakistan, Nepal, Bhutan, Bangladesh and Sri Lanka.

Cutting edge reviews by leading researchers illuminate key aspects of DNA repair in mammalian systems and its relationship to human genetic disease and cancer. Major topics include UV and X-Ray repair, repair of chemical damage, recombinational repair, mismatch repair, transcription-repair coupling, and the role of DNA repair in disease prevention. Extensive up-to-date references and rigorous peer-review of each chapter make this volume definitive and bring it to the active frontiers of research.

Respiratory Neurobiology: Physiology and Clinical Disorders, Part Two, Volume 189 is one of two volumes on the neurology of breathing. This volume focuses on pathologies attributable to abnormalities of the neural control of breathing, breathing problems that may occur in neurological diseases, and the neurological complications of respiratory diseases, while volume one focuses on the neurophysiology of breathing.

Cancer is one of the leading killers in the world and the incidence is increasing, but most cancer patients and cancer survivors suffer much from the disease and its conventional treatments' side effects. In the past, clinical data showed that some complementary and alternative medicine (CAM) possessed anticancer abilities, but some clinicians and scientists have queried about the scientific validity of CAM due to the lack of scientific evidence. There is great demand in the knowledge gap to explore the scientific and evidence-based knowledge of CAM in the anticancer field. With this aim, a book series is needed to structurally deliver the knowledge to readers. Integrative therapies comprise a variety of non- pharmacological interventions that assist in alleviating physical and psychological symptoms. Apart from being a life-threatening disease, cancer and its therapy are usually associated with a significant deterioration in the quality of life. There is growing evidence that non-pharmacological therapies provide symptom and pain management in cancer palliation. This volume is a specialised book presenting the research evidence relevant to the application of a range of commonly used non-pharmacological interventions in supportive cancer care, including massage, acupressure, Qigong, yoga, mind-body therapy, mindfulness-based intervention, and aromatherapy. A number of scientific researches and clinical studies support that these therapies offer potential beneficial effects for cancer patients in terms of reducing pain, anxiety, and other symptoms. Indeed, non-pharmacological therapies are increasingly gaining acceptance in the healthcare community as complementary to conventional cancer treatments. Most of them are non-invasive, inexpensive, and useful in improving quality of life, and they may be accessed by patients themselves.

This book provides a thought-provoking guide to conducting collaborative arts-based research. Focusing on ways that social inquiry might be conducted with marginalised groups to promote social justice, the text offers chapters on: Telling 'alternative' stories through a variety of methods from crafts to digital film Visual and metaphorical approaches to social research including photography, art and poetry Performative methods that include drama, dance, music and performance art Foster introduces relevant methodological debates, giving a context for understanding when arts-based research can be a fruitful approach to take and outlining a convincing rationale for using the arts as a way of understanding and representing the social world. The book also suggests a range of alternative criteria for evaluating the quality of arts-based research. Illustrative examples from around the world are used throughout the book and an extended case study is included that focuses on Foster's own collaborative arts-based research. With their emphasis on the value of participative research and social justice, arts-based methodologies are becoming increasingly popular in health and social research. This is the ideal text for anyone looking to introduce arts-based methods into their research practice.

Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focused on the practical aspects of SOPs and SOP management. The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example "SOP of SOPs" along with an associated SOP template.

This book brings together a collection of empirical case studies featuring a wide spectrum of medical innovation. While there is no unique pathway to successful medical innovation, recurring and distinctive features can be observed across different areas of clinical practice. This book examines why medical practice develops so unevenly across and within areas of disease, and how this relates to the underlying conditions of innovation across areas of practice. The contributions contained in this volume adopt a dynamic perspective on medical innovation based on the notion that scientific understanding, technology and clinical practice co-evolve along the co-ordinated search for solutions to medical problems. The chapters follow an historical approach to emphasise that the advancement of medical know-how is a contested, nuanced process, and that it involves a variety of knowledge bases whose evolutionary paths are rooted in the contexts in which they emerge. This book will be of interest to researchers and practitioners concerned with medical innovation, management studies and the economics of innovation. Chapter 5 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. https://s3-us-west-2.amazonaws.com/tandfbis/rt-files/docs/Open+Access+Chapters/9781138860346_oachapter5.pdf

Mitochondria, often referred to as the "powerhouses" of the cell, generate adenosine triphosphate (ATP) by oxidative phosphorylation or OXPHOS, and maintain cellular homeostasis. In addition to generating ATP, mitochondria are involved in regulation of cell cycle, proliferation, free radical production, innate immune responses and apoptosis. Mitochondrial Function in Lung Health and Disease fills the current gap in the literature and outlines the growing clinical relevance of mitochondrial dysfunction. Currently, there is no overview on the role of mitochondria in pulmonary diseases and this volume focuses on the mitochondrial metabolism, redox signaling, and mechanisms of mitochondrial pathways in lung injury, inflammation, repair and remodeling. Furthermore, in addition to their well-recognized role in cellular energy production and apoptosis, mitochondria appear to play a role in many respiratory diseases and lung cancer. Chapters are written by top notch researchers and clinicians and outline the evidence for mitochondrial biogenesis in inhalational lung injury, COPD and asthma.

In Silico Drug Discovery and Design: Theory, Methods, Challenges, and Applications provides a comprehensive, unified, and in-depth overview of the current methodological strategies in computer-aided drug discovery and design. Its main aims are to introduce the theoretical framework and algorithms, discuss the range of validity, strengths and limitations of each methodology, and present applications to real world problems in the drug discovery arena. Special emphasis has been given to the emerging and most pressing methodological challenges in in silico drug discovery and design. The book assumes a basic knowledge of physical principles and molecular modeling. Particular attention has been paid to outline the underlying physico-chemical foundation of the methods described, thus providing the necessary background to avoid a "black-box" approach. In each self-contained chapter, this is presented together with the latest developments and applications, and the challenges that lie ahead. Assembling a unique team of experts to weigh in on the most important issues influencing modern computational drug discovery and design, this book constitutes both a desktop reference to academic and industrial researchers in the field, and a textbook for students in the area of molecular modeling and drug discovery. Comprised of 18 chapters and divided into three parts, this book: Provides a comprehensive, unified, and in-depth overview of the current methodological strategies in computer-aided drug discovery and design Outlines the underlying physico-chemical foundation of the methods described Presents several applications of computational methods to real world problems in the drug design field Helps to avoid a "black-box" approach to in silico drug discovery Constitutes an actual textbook for students in the area of molecular modeling and drug discovery Gives the reader the adequate background to face the current challenges of the field In Silico Drug Discovery and Design: Theory, Methods, Challenges, and Applications describes the theoretical framework, methods, practical applications and case examples relevant to computer-aided drug lead discovery and design. This text will surely aid in understanding the underlying physical foundation of computational tools and their range of application, thus facilitating the interpretation of simulation results.

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.

The use of human tissue for medical research and scientific progress raises many ethical and legal challenges. The procurement, storage and transfer of human tissue for research purposes have posed significant questions over recent years, and a number of high profile scandals in the UK prompted the publication of the Madden Report on Post Mortem Practice and Procedures in Irish hospitals in 2006. Additionally, tissue-related research tends to be most promising if samples and information are shared across national borders, but the heterogeneity of current rules and guidelines within the member states of the European Union calls all the more for clarification.
This multi-authored interdisciplinary text, edited by four experienced researchers, explores many of the issues concerning biobank-related research and aims to provide answers to the most urgent questions by means of ethical, philosophical, and legal investigation. It provides a fascinating insight into a wide range of interlinking research perspectives and serves as a comprehensive reference to the state of play ethically and legally in Europe. It will be of value to medics and social scientists, human tissue researchers, and policy makers who have an interest in ethical and legal issues of human tissue research.

Understanding Research in Clinical and Counseling Psychology, Second Edition, is written and designed for graduate students in the psychology and counseling fields, for whom the value of psychological research is not always readily apparent. Contributed to by experts in their respective fields, this text presents research as an indispensable tool for practice, a tool that is used every day to advance knowledge and improve assessment, treatment choice, and client outcomes. The book is divided into four logical parts: Research Foundations, Research Strategies, Research Practice, and finally, Special Problems. Included is a chapter that addresses one of the most important controversies, the distinction between realistic and "gold standard" efficacy studies. The remainder of the book addresses salient issues such as conducting research in various cultures, operating an empirically-oriented practice, and performing research with families, children, and the elderly. Students and professors will find the coverage ample and penetrating, without being too overwhelming.

"Stem Cell and Gene Therapy for Heart Failure" is a state-of-the-art reference that combines the both the breadth and depth of information available in one place. Stem cell and gene therapy is the most cutting edge therapy currently available for patients with heart failure and the therapy has progressed to availability in multiple clinical trials. Each section of this resource includes trials from contributors and specialists from around the world that have been completed to date as well as planned for the future, making this an important resource for cardiology researchers, basic science clinicians, fellows, residents, students, as well as industry.
Includes coverage of the three areas with the greatest clinical trials to date: Chronic Limb Ischemia, Chronic Angina, and Acute MI.Provides the current understanding of harnessing the body s native repair mechanisms.Offers future perspectives outlining prospective directions, new trials and exploring unanswered questions.
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Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive randomization designs? Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects answers these questions and more. From novel designs to cutting-edge applications, this book presents several new and key developments in adaptive randomization. It also offers a fresh and critical look at a number of already-classical topics. Featuring contributions from statisticians, clinical trialists, and subject-matter experts in academia and the pharmaceutical industry, the text: Clarifies the taxonomy of the concept of adaptive randomization Discusses restricted, covariate-adaptive, response-adaptive, and covariate-adjusted response-adaptive (CARA) randomization designs, as well as randomized designs with treatment selection Gives an exposition to many novel adaptive randomization techniques such as brick tunnel randomization, targeted least absolute shrinkage and selection operator (LASSO)-based CARA randomization, multi-arm multi-stage (MAMS) designs, to name a few Addresses the issues of statistical inference following covariate-adaptive and response-adaptive randomization designs Describes a successful implementation of a single pivotal phase II/III adaptive trial in infants with proliferating hemangioma Explores some practical aspects of phase II dose-ranging studies and examines statistical monitoring and interim analysis issues in response-adaptive randomized clinical trials Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects covers a wide spectrum of topics related to adaptive randomization designs in contemporary clinical trials. The book provides a thorough exploration of the merits of adaptive randomization and aids in identifying when it is appropriate to apply such designs in practice.

"Explains why a significant body of scientific research has been largely ignored by cancer research institutions. Hess has clearly demonstrated the valuable role that social scientists can have in offering a neutral perspective on medical research and how it is shaped by cultural bias."
--"Townsend Letter"

"Hess has made a careful study of one of the most intriguing themes that weaves through the recent history of unconventional approaches to cancer. Every researcher, physician, and general reader interested in this field should welcome this important and incisive contribution."
--"Michael Lerner
President, Commonweal, and author of "Choices in Healing"

Growing numbers of cancer patients are exploring diet, food supplements, herbs, and nontoxic immunotherapies like bacterial vaccines as a means of therapy. Yet most cancer research organizations refuse to even evaluate these alternatives. "Can Bacteria Cause Cancer?" argues convincingly that unless this neglected world of alternative therapies is properly scrutinized, the medical Vietnam of the twentieth century may well affect one in two people by the twenty-first century.

David J. Hess investigates one of the great medical mysteries of the twentieth century--the relationship between bacteria and chronic disease. Recently scientists have overturned long-held beliefs by demonstrating that bacterial infections cause many ulcers; they are now reconsidering the role of bacterial infections in other chronic diseases, such as arthritis. Is it possible, Hess asks, that bacteria can contribute to the many other known causes of cancer?

To answer this intriguing question, Hess takes us into the world of alternative cancerresearchers. Maintaining that their work has been actively suppressed rather than simply dismissed, he examines their claims---that bacterial vaccines have led to some dramatic cases of long-term cancer remission--and the scientific potential of their theories. Economic interests and cultural values, he demonstrates, have influenced the rush toward radiation and chemotherapy and the current cul-de-sac of toxic treatments.

More than a medical mystery story, "Can Bacteria Cause Cancer?" is a dramatic case study of the failure of the war on cancer.

Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine.

"Integrative Approaches for Health: Biomedical Research, Ayurveda and Yoga" brings together interdisciplinary and integrative approaches to health and medicine in one comprehensive reference. It covers the concept of Evidence Based Medicine (EBM) as a common thread to connect medical systems, facilitating dialogue and triggering the evolution of Integrative Medicine. The basic principles of Ayurveda and Yoga are connected and juxtaposed to the modern systems biology including the complex relationships between cells, tissues, organs and body to get better and inclusive picture of Integrative Medicine. This book introduces readers the potentials of Ayurveda and Yoga as important components of Integrative Medicine as also knowledge sources for future research in biomedicine.
Contains a confluence of ancient and modern concepts, historical perspectives, philosophical underpinnings and an extensive review of literature supported by worldwide case studies. Provides a contemporary analysis of ancient wisdom, pointing to potential areas for future research, allowing for contemplation of forthcoming healthcare and integrative medicine practices.Offers illustrative charts, timelines and entity relationship logic diagrams for enhanced understanding of concepts presented.Shows Ayurveda knowledge and its relevance to drug discovery, personalized medicine, genomics, epigenomics, regenerative medicine, longevity, and nanotechnology.Shares yoga knowledge insights and explains its relevance to body -mind complex relationships, psycho-neuro-immuno-endocrinology, bioenergetics, consciousness, and cognitive sciences.

Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement. Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.

A complete guide to understanding cluster randomised trials Written by two researchers with extensive experience in the field, this book presents a complete guide to the design, analysis and reporting of cluster randomised trials. It spans a wide range of applications: trials in developing countries, trials in primary care, trials in the health services. A key feature is the use of R code and code from other popular packages to plan and analyse cluster trials, using data from actual trials. The book contains clear technical descriptions of the models used, and considers in detail the ethics involved in such trials and the problems in planning them. For readers and students who do not intend to run a trial but wish to be a critical reader of the literature, there are sections on the CONSORT statement, and exercises in reading published trials. * Written in a clear, accessible style * Features real examples taken from the authors extensive practitioner experience of designing and analysing clinical trials * Demonstrates the use of R, Stata and SPSS for statistical analysis * Includes computer code so the reader can replicate all the analyses * Discusses neglected areas such as ethics and practical issues in running cluster randomised trials How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research provides an excellent reference tool and can be read with profit by statisticians, health services researchers, systematic reviewers and critical readers of cluster randomised trials.

How to identify optimal phase II trial designs Providing a practical guide containing the information needed to make crucial decisions regarding phase II trial designs, A Practical Guide to Designing Phase II Trials in Oncology sets forth specific points for consideration between the statistician and clinician when designing a phase II trial, including issues such as how the treatment works, choice of outcome measure and randomization, and considering both academic and industry perspectives. A comprehensive and systematic library of available phase II trial designs is included, saving time otherwise spent considering multiple manuscripts, and real-life practical examples of using this approach to design phase II trials in cancer are given. A Practical Guide to Designing Phase II Trials in Oncology: * Offers a structured and practical approach to phase II trial design. * Considers trial design from both an academic and industry perspective. * Includes a structured library of available phase II trial designs. * Is relevant to both clinical and statistical researchers at all levels * Includes real life examples of applying this approach. * For those new to trial design, A Practical Guide to Designing Phase II Trials in Oncology will be a unique and practical learning tool, providing an introduction to the concepts behind informed decision making in phase II trials. For more experienced practitioners, the book will offer an overview of new, less familiar approaches to phase II trial design, providing alternative options to those which they may have previously used.

Patient organizations and social health movements offer one of the most important and illuminating examples of civil society engagement and participation in scientific research and research politics. Influencing the research agenda, and initiating, funding and accelerating the development of diagnostic tools, effective therapies and appropriate health-care for their area of interest, they may champion alternative, sometimes controversial, programs or critique dominant medical paradigms. Some movements and organizations advocate for medical recognition of contested illnesses, as with fibromyalgia orADHD, while some attempt to "de-medicalize" others, such as obesity or autism. Bringing together an international selection of leading scholars and representatives from patients' organizations, this comprehensive collection explores the interaction between civil society groups and biomedical science, technology development, and research politics. It takes stock of the key findings of the research conducted in the field over the past two decades and addresses emerging problems and future challenges concerning the interrelations between health movements and patient organisations on the one hand, and biomedical research and research policies on the other hand. Combining empirical case studies with conceptual discussion, the book discusses how public participation can contribute to, as well as restrict, the democratization of scientific knowledge production. This volume is an important reference for academics and researchers with an interest in the sociology of health and illness, science and technology studies, the sociology of knowledge, medical ethics or healthcare management and research, as well as medical researchers and those involved with health-related civil society organizations.

The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. However, despite these advances, no book has served as a single source of information for statistical methods in drug combination research, nor has there been any guidance for experimental strategies. Statistical Methods in Drug Combination Studies fills that gap, covering all aspects of drug combination research, from designing in vitro drug combination studies to analyzing clinical trial data. Featuring contributions from researchers in industry, academia, and regulatory agencies, this comprehensive reference: Describes statistical models used to characterize dose-response patterns of monotherapies and evaluate the combination drug synergy Offers guidance for estimating interaction indices and constructing their associated confidence intervals to assess drug interaction Introduces a practical and innovative Bayesian approach to Phase I cancer trials, including actual trial examples to illustrate use Examines strategies in the fixed-dose combination therapy clinical development via case studies stemming from regulatory reviews Evaluates computational tools and software packages used to apply novel statistical methods in combination drug development Statistical Methods in Drug Combination Studies provides researchers with a solid understanding of the available statistical methods and computational tools and how to apply them in drug combination studies. The book is equally useful for statisticians to become better equipped to deal with drug combination study design and analysis in their practice.