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.
Secrecy and the Media is the first book to examine the development of the D-Notice system, which regulates the UK media's publication of British national security secrets. It is based on official documents, many of which have not previously been available to a general audience, as well as on media sources. From Victorian times, British governments have consistently seen the need, in the public interest, to prevent the media publishing secret information which would endanger national security. The UK media have meanwhile continuously resisted official attempts to impose any form of censorship, arguing that a free press is in the public interest. Both sides have normally seen the pitfalls of attempting to resolve this sometimes acrimonious conflict of interests by litigation, and have together evolved a system of editorial self-regulation, assisted by day-to-day independent expert advice, known colloquially as the D-Notice System. The book traces the development of this system from nineteenth-century colonial campaigns, through two world wars, to modern operations and counter-terrorism in the post-Cold War era, up to the beginning of the Labour government in 1997. Examples are drawn from media, political and official sources (some not yet open), and cover not only defence issues (including Special Forces), but also the activities of the secret intelligence services MI5, MI6 and GCHQ. These cases relate principally to the UK, but also to American and other allies' interests. The story of how this sometimes controversial institution now operates in the modern world will be essential reading for those in the media and government departments, and for academics and students in the fields of security, defence and intelligence, as well as being an accessible expos for the general reader. Nicholas Wilkinson served in the Royal Navy 1959-98, and from 1999 to 2004 he ran the independent Defence, Press and Broadcasting Advisory Committee. He was a Press Complaints Commissioner from 2005 to 2008, and is a Cabinet Office Historian.
Climate change is one of the most controversial and misunderstood issues of the 21st century. This book provides a clear understanding of the issue by presenting scientific facts to refute falsehoods and misinformation-and to confirm the validity of other assertions. Is public understanding of global warming suffering from politically biased news coverage? Is it true that the global scientific community has not reached a consensus on whether humans are causing climate change? This important book addresses these questions and many more about global warming, identifying common claims about climate change and using quantifiable, evidence-based information to examine their veracity. The authors of this work examine 35 specific claims that have been made about global climate change by believers and skeptics. These assertions-some true, some false-will guide readers to a much deeper understanding of the extent of climate change; whether any climate change that is taking place is human-caused; whether climate change is likely to be a serious problem in the future; whether scientists agree on the fundamentals of climate change; and whether climate change impacts can be mitigated. Examples of specific issues that are scrutinized and explained in the book include: trends in the extent and condition of Arctic and Antarctic Sea ice packs, the accuracy of climate forecasting models, whether extreme weather events are increasing as a result of climate change, and the benefits and drawbacks of various schemes to limit greenhouse gas emissions.
Drug delivery technologies represent a vast, vital area of research and development in pharmaceuticals. The demand for innovative drug delivery systems continues to grow, driving a variety of new developments. Drug Delivery Systems, Third Edition provides a comprehensive review of the latest research and development on drug delivery systems. Coverage includes liposomal, transmucosal, transdermal, oral, polymeric, and monoclonal antibody directed delivery. Each chapter provides a table of marketed and investigational products with numerous practical examples. The book also provides readers with a multitude of possible drug delivery systems that can be used to improve therapeutics, along with global and regulatory perspectives. This third edition contains a chapter on nanoscience and technology for drug delivery along with cutting-edge business intelligence and strategies. Written in a straightforward manner, the authors provide a global perspective on current and future advances and market opportunities. Supplying a cogent overview of the field and extensive guidance on where to get more information, it is an essential resource for anyone venturing into this area of drug development.
The aim of this book is to promote the thesis that myth may illuminate archaeology and that on occasion archaeology may shed light on myth. Medieval Irish literature is rich in mythic themes and some of these are used as a starting point. Some myths are of great antiquity and some were invented by contemporary authors. It is a challenging source, first explored in the author's earlier work Archaeology and Celtic Myth and this work will elaborate on some of the themes pursued there and introduce some new ones. Combining literary and archaeological evidence, chapters deal with the construction of the past, illustrating how the Irish medieval world invented aspects of the past; the abuses of myth presented in later literature; the evidence for the survival of pagan beliefs and practices well into medieval times in Ireland; evidence to illustrate the key elements of the institution of sacral kingship, a consideration of sacred trees; mythology of the underworld and its archaeological expressions; and the equine aspects of the myths attached to the Irish goddess Macha (linked to Navan Fort) and her Welsh counterpart Rhiannon. John Waddell brings a lifetime's experience of studying Irish history, Bronze Age archaeology and Celtic mythology in this personal and lively exploration of mythology and its archaeological expression.
The ideal introduction to qualitative research′s theories, strategies, and practices, Creswell and Poth′s Qualitative Inquiry and Research Design explores five qualitative research approaches: narrative research, phenomenology, grounded theory, ethnography, and case study. Packed with updated content and examples, this Fifth Edition guides readers to select the best qualitative approach for their studies.
2015 BMA Medical Book Awards Highly Commended in Oncology Category!The Molecular Basis of Cancer arms you with the latest knowledge and cutting-edge advances in the battle against cancer. This thoroughly revised, comprehensive oncology reference explores the scientific basis for our current understanding of malignant transformation and the pathogenesis and treatment of this disease. A team of leading experts thoroughly explains the molecular biologic principles that underlie the diagnostic tests and therapeutic interventions now being used in clinical trials and practice. Detailed descriptions of topics from molecular abnormalities in common cancers to new approaches for cancer therapy equip you to understand and apply the complexities of ongoing research in everyday clinical application. - Effectively determine the course of malignancy and design appropriate treatment protocols by understanding the scientific underpinnings of cancer. - Visually grasp and retain difficult concepts easily thanks to a user-friendly format with abundant full-color figures. - Find critical information quickly with chapters following a logical sequence that moves from pathogenesis to therapy. - Stay current with the latest discoveries in molecular and genomic research. Sweeping revisions throughout include eight brand-new chapters on: Tumor Suppressor Genes; Inflammation and Cancer; Cancer Systems Biology: The Future; Biomarkers Assessing Risk of Cancer; Understanding and Using Information About Cancer Genomes; The Technology of Analyzing Nucleic Acids in Cancer; Molecular Abnormalities in Kidney Cancer; and Molecular Pathology. - Access the entire text and illustrations online, fully searchable, at Expert Consult.
Clear, up-to-date guidance for professionals working with children with obesity One in every six children, and more in some ethnic groups, are obese, which can lead to serious health problems in adulthood. Successful treatment of young patients is complex, requiring time-intensive, evidence-based care delivered by a multidisciplinary team. Help is at hand with this well written, compact book by leading experts, which gives health professionals a clear overview of the current scientific knowledge on childhood obesity, from causality models and diagnosis to prevention and treatment. In particular, the authors outline a family-based treatment method which is best supported by the evidence and meets the recommendations of the American Academy of Pediatrics and other organizations. The appendix provides the clinician with hands-on tools: a session plan, a pretreatment assessment form, selfmonitoring forms, and a meal planning and physical activity worksheet. This book is essential reading for anyone who works with children and their families, equipping them to guide patients to appropriate and effective treatment.
Change is constant in everyday life. Infants crawl and then walk, children learn to read and write, teenagers mature in myriad ways, the elderly become frail and forgetful. Beyond these natural processes and events, external forces and interventions instigate and disrupt change: test scores may rise after a coaching course, drug abusers may remain abstinent after residential treatment. By charting changes over time and investigating whether and when events occur, researchers reveal the temporal rhythms of our lives. Applied Longitudinal Data Analysis is a much-needed professional book for empirical researchers and graduate students in the behavioral, social, and biomedical sciences. It offers the first accessible in-depth presentation of two of today's most popular statistical methods: multilevel models for individual change and hazard/survival models for event occurrence (in both discrete- and continuous-time). Using clear, concise prose and real data sets from published studies, the authors take you step by step through complete analyses, from simple exploratory displays that reveal underlying patterns through sophisticated specifications of complex statistical models. Applied Longitudinal Data Analysis offers readers a private consultation session with internationally recognized experts and represents a unique contribution to the literature on quantitative empirical methods. Visit http://www.ats.ucla.edu/stat/examples/alda.htm for: BL Downloadable data sets BL Library of computer programs in SAS, SPSS, Stata, HLM, MLwiN, and more BL Additional material for data analysis
Preferring anonymity, Murdoch John McSween wrote over 80 letters under the pseudonym "Long Grabs" to the Fayetteville Observer (North Carolina), serving as their unofficial war correspondent. For the first two full years of the war, 1862-1863, he was a sometimes drill master at Camp Mangum, in Raleigh, and a wanderer among the regiments in North Carolina and Virginia. What he wrote was varied--the fighting in eastern North Carolina and at Fredericksburg and Petersburg in Virginia, the conditions of the soldiers, the hardships of the civilians, the history of places he visited, and biographical sketches such as that of Jefferson Davis. In 1863, based on certain promises made by Colonel Matt Ransom, McSween joined the 35th Regiment. A bitter dispute soon developed over those promises with the result that McSween was court-martialed and sentenced to twelve months at hard labor. Released, he joins the 26th Regiment and is twice wounded at the Battle of Petersburg. After the war, he returns to Fayetteville where he edits and publishes The Eagle newspaper.
Although Lancaster was the ancient County town, it had a population of only 40,000 in 1914. Of these, it is thought that some 5,000 men saw war service between 1914-18, and over 1,000 did not return. In consequence, the recruiting drives, the tribunals to consider exemption from 1916, and the ever-growing casualty lists provide the main theme for this book.Some 3,000 men had volunteered by December 1914, to join those already serving. While the depot of the Kings Own Royal Lancaster Regiment was in the town, about eighty regiments had Lancaster men in their ranks, and both the casualty lists and the awards for gallantry reflect this.The town was out of range for shelling from the sea, or aerial bombardment, but did experience an explosion at its munitions factory in 1917. Apart from this, the mayor and council endeavoured to continue with their primary duties as far as possible in running the town.
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