This book has it all, travel, adventure, romance, comedy, drama, sex and speedway racing. It is a story about living our dream of traveling Australia and the world, at the same time pursuing our great sporting love, speedway. From our caravan travels through Northern New South Wales and Southern Queensland to the lush, green hills of the Emerald Isle, the historic ruins of Italy, the desert climes of Dubai, our visit to see our daughter in South Africa and to be there for the birth of our first grandchild. We had such an adventure. But, this was before the Global Financial Crisis and before the collapse of Townsville-based STORM Financial in whose hands we had trustfully placed our financial future. Little did we know what devastation lay ahead. Still, my story here, covers a much calmer time and will hopefully entice budding retirees to be a little adventurous when planning future travels. It was fun while it lasted.
New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.
Having trouble finding a book that shows you not only how to analyze data but also how to collect the data appropriately and fully interpret the analysis, too? Here′s a new book that does all this in a particularly readable fashion. Turner and Thayer′s text: Shows how to design an experiment in the best possible way to investigate the topic of interest Explains which associated analysis will best answer your research question Demonstrates how to conduct the analysis and then fully interpret the results in the context of your research question Organized so that the reader moves from the simplest type of design to more complex ones, the authors introduce five different kinds of ANOVA techniques and explain which design/analysis is appropriate to answer specific questions. They show how to perform each analysis using only a calculator to provide the reader with a better "feel" for the analyses than simply seeing the mathematical answers on a computer print-out. The book concludes with tips for tests on ANOVA, and descriptions of how to use the knowledge gained from the text to determine the credibility of claims made and "statistics" presented in various types of reports.
This Brief discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decision-making that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be prescribed a drug that is on the market). These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance.
The key to preventing many adult diseases lies in childhood, when lifetime patterns of diet, exercise, and moderation are most often set. Authored by an interdisciplinary team including nurses, psychologists, nutritionists, and researchers, this book provides a research-based examination of the interplay between health and behavior in childhood and adolescence leading to either positive or negative health outcomes. It examines issues such as: What role does temperament play in at-risk behavior? How can we improve dietary choices? How can we reduce the cycle of physical inactivity leading to obesity? What makes some children more prone to substance abuse? This book provides a long-range perspective on health promotion, by examining its roots in the early years of life.
At a time when the field of cardiac safety is going through important changes, this unique book provides the rationale for, and cutting-edge explanations of, new regulatory landscapes that will likely govern cardiac safety assessments globally for the foreseeable future. Exposure-response modeling is already being accepted by regulatory agencies in lieu of the traditional Thorough QT/QTc Study, and the Comprehensive in vitro Proarrhythmia Assay initiative is well under way. Developments in the field of cardiovascular safety are also described and discussed in the book. These include the search for more efficient ways to exonerate new drugs for type 2 diabetes from an unacceptable cardiovascular liability, how best to address off-target blood pressure increases induced by noncardiovascular drugs, and the continued evolution of the discipline of Cardio-oncology. “a resource that will likely serve as a standard for years to come” - Dr Jonathan Seltzer Therapeutic Innovation & Regulatory Science, 2017;51(2):180 “I have no hesitation in recommending this book as a valuable reference source” - Dr Rashmi Shah Journal for Clinical Studies, 2017;9(1):62-63
The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students.
This book is an articulate, concise, contemporary introduction to the study of important variables underlying cardiovascular reactivity. Its strength is in the combination of a scholarly but nonpedantic approach to cardiovascular psychophysiology and a solid understanding of be havioral medicine approaches to the study of hypertension. The topics covered are central to the study of relationships between behavior and cardiovascular reactivity; the list of suggested readings at the end of each chapter provides excellent guidance for more detailed study of specific issues. It has now been more than a dozen years since Plenum Press published Paul Obrist's seminal monograph Cardiovascular Psycho physiology. The volume had a major impact in relating cardiovascular regulation to behaving individuals and in developing thoughtful hy potheses concerning such factors as they might pertain to hypertension. The impact of that work extended across scientific disciplines as well as aross continents. At the time the Obrist book was published, a young psychologist, J. Rick Turner, was completing his Ph. D. thesis in psychol ogy at the University of Birmingham, England, on heart rate reactions to psychological challenge. After continued collaboration for the next several years with his former Ph. D. mentor, Douglas Carroll, Turner joined the Obrist laboratory at the University of North Carolina. Al though Obrist unfortunately died during Turner's tenure in the labora tory, collaboration continued with Kathleen Light and Andrew Sher wood. The enlightened legacy of the North Carolina laboratory can clearly be seen in this text.
This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.
When writing this book, I assumed that the reader would have already read my first offering, “The Calm Before STORM” which dealt with travels during the first year of our retirement, 2006. If you have not, I suggest you do. Why? Simply, it’s a darn good read. Honestly though, you need not have read “Calm” before this one. “STORM in the Rear-view” will make perfect sense regardless, as I detail our further adventures in the two following years, during which, unknowingly, the GFC and the STORM Financial catastrophe were bearing down upon us. I will take you on a caravan journey right around our beautiful continent of Australia, and our off-shore state, Tasmania, come with us to Johannesburg, South Africa for the birth of our Grandson, climb Mt Kilimanjaro, drive through the Eastern bloc countries of Europe, visit Turkey and Vietnam, along the way catching numerous events of the world’s greatest motor sport, Speedway. You’ll be exhausted but the journey will be well worthwhile. Let’s go!
Take Back Your Life and Walk Peacefully and Free Is your mind a playground for the devil? Are you harassed and held hostage by thoughts, fears, anxiety, and depression that won't let up? You're not alone. The number of people suffering from mental torment is staggering because the devil is a master at mind games. But God has already beat him at his game and offers you power to overcome! In God’s Path to Mental Health, four Harrison House authors—Rick Renner, Eddie Turner, Kylie Oaks Gatewood, and Germaine Copeland—team up to deliver scriptural and supernatural help such as: How you can win on the mind battlefield What to do when the devil "trash talks" you Dressing yourself in impenetrable armor Wielding your supernatural weaponry Scriptures that shut up the devil These four authors have each been through the trenches when it comes to obsessive thoughts and depression, and they’ve practiced what they preach to defeat mental torment and find God’s pathway to mental health. Now it’s your turn! Let them help you take back your life and walk peacefully and free!
Heart disease is the Number 1 Killer of both men and women in the United States. Every minute of every day, someone dies from it. However, you can do a lot to prevent heart disease by making some simple changes in your lifestyle. The 6 Step Healthy Heart Program will lower your risk of heart disease, lower your risk of other chronic diseases including cancer and diabetes, and improve your quality of life each day.
As a coaching neophyte attempts to navigate the scurrilous underbelly of professional basketball, he encounters a number of fascinating characters along the way--some of whom shape his journey and others who impede it. He becomes a fly on the wall to the swirling world around him and reports his voyage as it takes him from the comfortable suburbs of the Pacific Northwest, across the U.S. and back.
This book is an endearing story about a little boy named Bobby Turner, who always enjoyed seeing the circus when it came to town every year. This year, little Bobby Turner has the chance of a lifetime; he is invited to join the circus and perform with his favorite clown, Bo-Bo and his silly monkey Chi-Chi.
All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics. Introduction to Statistics in Pharmaceutical Clinical Trials is an ideal introduction to statistics presented in the context of clinical trials conducted during pharmaceutical drug development. This novel approach both teaches the computational steps needed to conduct analyses and provides a conceptual understanding of how these analyses provide information that forms the rational basis for decision making throughout the drug development process.
Biopharmaceutical drugs improve the health and well-being of people across the globe on a scale that is unrivaled by any other medical intervention. Before these drugs can be prescribed for patients by their doctors, they have to be approved for marketing by a regulatory agency. To gain marketing approval, drugs must go through an extremely rigorous process that investigates their safety and efficacy, the process of New Drug Development. The last stage of this long, complex, and expensive process involves conducting clinical trials, the topic of this book. Successfully conducting clinical trials requires the interdisciplinary collaboration of individuals from many clinical and scientific disciplines and areas of operational expertise. These include medicine, information technology, ethics and law, statistics, clinical trial operations, data collection and management, regulatory science, and medical writing, to name just a few. Central aspects of conducting clinical trials are discussed in the following chapters, with the goals of making specialists from each of these areas aware of the contributions of their colleagues, and helping readers to appreciate that everyone involved in clinical research is working side-by-side toward a common goal---improving the health, well-being, and longevity of millions of patients around the globe.
New Drug Development, 2nd Edition, is a reader-friendly introduction to clinical trials that is written specifically for entry-level professionals in the pharmaceutical, biopharmaceutical, and contract research organization (CRO) industries. It is also excellent reading for seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate fields of expertise, and for students of clinical research, pharmacy, medicine, nursing, and allied health professions. While the main focus is on preapproval clinical trials, the book adopts a lifecycle drug development approach, placing these trials in the overall continuum from drug discovery to postmarketing surveillance. It therefore contains brief discussions of medicinal chemistry, nonclinical research, drug manufacturing, and the latest techniques for gathering information concerning adverse drug reactions. This edition builds on the success of the first edition by keeping the discussions that were most helpful to readers, and adding new chapters addressing important contemporary topics in drug development. The chapters dealing with the design and analysis of clinical trials in the first edition received praise from many sources. This new edition incorporates extended discussions of the operational aspects of conducting various kinds of trials, ranging from highly specialized and relatively small cardiac safety studies to very large, multi-site Phase III trials run in several different countries.
The New York Times–bestselling authors tell the inspiring story of their rise to talk radio fame—and the ups and downs of their lives off the air. If you’ve ever started your day with Rick and Bubba, you know the unmistakable drawl of those two crazy Alabama boys. What you may not know is that they almost weren’t “Rick and Bubba.” From their glory days of homemade “radio stations,” youthful athletic ambition, and redneck Shakespearean monologues, Rick and Bubba spent decades working out the personalities you hear today on their syndicated morning talk show. Born in a little studio behind a skating rink, The Rick & Bubba Show filled the airwaves with a voice never before heard on morning radio. We Be Big follows the winding road that led Rick Burgess and Bill “Bubba” Bussey onto the right path after years of missing the off-ramp. Find out how what started as a comedy routine evolved into a genuine conversation that more than 3.5 million people listen in on each week; and learn all the stories behind Rick and Bubba’s famous on-air hijinks, times of uncertainty, and unwavering faith in the face of tragedy. Meet the two “sexiest fat men alive,” and experience the hilarity and heartbreak of their unforgettable story.
The Vietnam War is only a fading memory for former Air Force Sergent Phillip Turner who now leads a simple life with his wife and 7-year-old son on their small Georgia farm. Then one day he spots a photograph in the local newspaper that turns his whole world upside down."--Jacket.
As the Washington Commanders step into a new era, celebrate the franchise's full NFL history with this revised and updated guide! Most Commanders fans have taken a trip or two to FedEx Field, have seen highlights of a young Art Monk, and know the story of Super Bowl XXVI. But only real fans know their way around the team's training camp facilities or in which famous baseball stadium the Redskins played in the team's early years.100 Things Commanders Fans Should Know & Do Before They Die is the fully up-to-date resource guide for true DC sports fans. Whether you attended games at RFK Stadium or are a new supporter of the team under head coach Ron Rivera, these are the 100 things all fans needs to know and do in their lifetime.Author Rick Snider has collected every essential piece of knowledge and trivia, as well as must-do activities, and ranks them all, providing an entertaining and easy-to-follow checklist as you progress on your way to fan superstardom.
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