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.
Because screenwriter Robert Riskin spent most of his career collaborating with legendary Hollywood director Frank Capra, Riskin's own unique contributions to film have been largely overshadowed. With five Academy Award nominations to his credit for such monumental films as Lady for a Day, Mr. Deeds Goes to Town, You Can't Take It with You, Here Comes the Groom, and It Happened One Night (for which he won the Oscar), Riskin is often imitated but rarely equaled. In Capra's Shadow: The Life and Career of Screenwriter Robert Riskin is the first sociohistorical analysis of the Hollywood pioneer's life and work. Author Ian Scott provides a unique perspective on Riskin, his impact on cinema, and the ways in which his brilliant, pithy style was realized in Capra's films.
Because screenwriter Robert Riskin (1897–1955) spent most of his career collaborating with legendary Hollywood director Frank Capra, his own unique contributions to film have been largely overshadowed. With five Academy Award nominations to his credit for the monumental films Lady for a Day, Mr. Deeds Goes to Town, You Can't Take It with You, Here Comes the Groom, and It Happened One Night (for which he won an Oscar), Riskin is often imitated but rarely equaled. Robert Riskin: The Life and Times of a Hollywood Screenwriter is the first detailed critical examination of the Hollywood pioneer's life and work. In addition to being one of the great screenwriters of the classic Hollywood era, Riskin was also a producer and director, founding his own film company and playing a crucial role in the foundation of the Screen Writers Guild. During World War II, Riskin was one of the major forces behind propaganda filmmaking. He worked in the Office of War Information and oversaw the distribution—and later, production—of films and documentaries in foreign theaters. He was interested in showing the rest of the world more than just an idealized version of America; he looked for films that emphasized the spiritual and cultural vibrancy within the United States, making charity, faith, and generosity of spirit his propaganda tools. His efforts also laid the groundwork for a system of distribution channels that would result in the dominance of American cinema in Europe in the postwar years. Author Ian Scott provides a unique perspective on Riskin and the ways in which his brilliant, pithy style was realized in Capra's enduring films. Riskin's impact on cinema extended far beyond these films as he articulated his vision of a changing America and helped spread Hollywood cinema abroad.
Scott L. Mingus Sr. and Eric J. Wittenberg, the authors of more than forty Civil War books, have once again teamed up to present a history of the opening moves of the Gettysburg Campaign in the two-volume study “If We Are Striking for Pennsylvania”: The Army of Northern Virginia and the Army of the Potomac March to Gettysburg. This compelling study is one of the first to integrate the military, media, political, social, economic, and civilian perspectives with rank-and-file accounts from the soldiers of both armies as they inexorably march toward their destiny at Gettysburg. This first installment covers June 3–21, 1863, while the second, spanning June 22–30, completes the march and carries the armies to the eve of the fighting. Gen. Robert E. Lee began moving part of his Army of Northern Virginia from the Old Dominion toward Pennsylvania on June 3, 1863. Lee believed his army needed to win a major victory on Northern soil if the South was to have a chance at winning the war. Transferring the fighting out of war-torn Virginia would allow the state time to heal while he supplied his army from untapped farms and stores in Maryland and the Keystone State. Lee had also convinced Pres. Jefferson Davis that his offensive would interfere with the Union effort to take Vicksburg in Mississippi. The bold movement would trigger extensive cavalry fighting and a major battle at Winchester before culminating in the bloody three-day battle at Gettysburg. As the Virginia army moved north, the Army of the Potomac responded by protecting the vital roads to Washington, D.C., in case Lee turned to threaten the capital. Opposing presidents Abraham Lincoln and Jefferson Davis, meanwhile, kept a close watch on the latest and often conflicting military intelligence gathered in the field. Throughout northern Virginia, central Maryland, and south-central Pennsylvania, meanwhile, civilians and soldiers alike struggled with the reality of a mobile campaign and the massive logistical needs of the armies. Thousands left written accounts of the passage of the long martial columns. Mingus and Wittenberg mined hundreds of primary accounts, newspapers, and other sources to produce this powerful and gripping account. As readers will quickly learn, much of it is glossed over in other studies of the campaign, which cannot be fully understood without a firm appreciation of what the armies (and civilians) did on their way to the small crossroads town in Pennsylvania.
Christians in general—and preachers of prophecy in particular—attribute the fulfillment of hundreds of Old Testament messianic prophecies to Jesus of Nazareth. Often these claims arise in the uncritical environment of Christian churches or popular literature that is treating messianic prophecy. People with critical thinking abilities, and those endowed with a skeptical nature, often have key questions that remain unaddressed in such environments. These thinkers and skeptics are the people that will be most interested in this work. The primary question addressed is this: “Do critically acceptable historical-evidential reasons exist for believing that Jesus Christ is the direct fulfillment of some specific Old Testament messianic texts?” Approaching this question within a framework that eliminates any possibility of staged prophetic fulfillment, and those that may occur by mere chance or collusion, produces results that must be taken seriously. Even with these strict criteria, Jesus emerges as the only viable candidate to fulfill some of the prophecies included in this study. For other prophetic texts, the evidence is not as abundant or convincing. However, even these texts yield several minimal facts that directly impinge on New Testament claims about Jesus.
Cambridge Studies in Biological and Evolutionary Anthropology
Published Date
ISBN 10
1107174414
ISBN 13
9781107174412
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