The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

David Bosch's Transforming Mission, now available in over a dozen languages, is widely recognized as an historic and magisterial contribution to the study of mission. Examining the entire sweep of Christian tradition, he shows how five paradigms have historically encapsulated the Christian understanding of mission and then outlines the characteristics of an emerging "postmodern" paradigm dialectically linking the transcendent and imminent dimensions of salvation. In this new anniversary edition, Darrel Guder and Martin Reppenhagen explore the impact of Bosch's work and the unfolding application of his seminal vision.

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, "Statistics in the Pharmaceutical Industry" has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition.

Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successfulfor industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies.

Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Portal hypertension is the most important complication of a great variety of both acute and chronic liver diseases. Nevertheless, hepatic cirrhosis is the most frequent cause of portal hypertension. Gastrointestinal bleeding due to rupture of oesophageal varices is, without doubt, the most severe complication of portal hypertension. At present, great advances are being made in the pathophysiology and in the development of new therapeutic tools for controlling and preventing this severe clinical event.

This book contains the papers presented and discussed during the Symposium on 'Portal Hypertension in the 21st Century', held in Montreal, Canada, in April 2004, and sponsored by Axcan Pharma Inc. and NicOx S.A. There are eight sections covering basic mechanisms, new drugs, prevention and current treatment of variceal bleeding, prevention of recurrent bleeding and hepatic hemodynamic monitoring.

An international faculty of authors have contributed chapters at an outstanding scientific level which will be vital reading for scientists and clinicians alike."

Uber die Tatsache, dass bei plotzlichen Todesfallen Kohlenmonoxyd-Hamo- globinwerte unterschiedlicher Hohe und unterschiedlichen Beweiswertes im Hinblick auf die Todesursache festgestellt werden konnen, ist oft berichtet worden (Bode u. Kampmann 1982; Geldmacher-v.Mallinckrodt 1975; Mueller 1953; Pollak 1978). Die Bedeutung dieser fruher haufigsten Ver- giftungsart ist inzwischen gegenuber anderen Intoxikationen zuruckge- gangen (Schwerd 1979). Im Hinblick auf die Zunahme von Kombinationsver- giftungen war uns wie anderen (Bode u. Kampmann 1982) in den letzten Jahren eine Zunahme der Falle mit niedrigen Kohlenmonoxyd-Hamoglobin- konzentrationen aufgefallen, deren Ursachen nicht unbedingt auf der Hand lagen. Wir wollten wissen, welche Bedeutung der Feststellung eines bestimmten CO-Hb-Wertes bei einem plotzlichen Todesfall heutzutage kommt. Material und Methoden Wir haben alle Falle des Institutes der vergangenen zwanzig Jahre, in denen eine Bestimmung des Gehaltes an Kohlenmonoxyd-Hamoglobin nach Heilmeyer (1933) mit der Zweilangenmethode bei 560 und 575 nm, modi- fiziert nach Schwerd (1962), wie von einem von uns beschrieben (Sellier 1953), vorgenommen worden war, aufgeschlusselt. 45 Falle mit einem Wert von 0% wurden von vornherein ausgeschieden, weil es sich offenbar um Routinekontrollen bei anderer gesicherter Todesursache gehandelt hatte. In 17 Fallen war die Feststellung von 0% CO-Hb von forensischer Bedeu- tung. Ausgehend von einer Gefahrdungsgrenze von = 50% CO-HB (Mueller 1953; Prokop u. Gohler 1976; Schwerd 1979) wurden in den Jahren 1963 bis 1982 insgesamt 26 Falle mit Werten zwischen 0 und ~ 50% analysiert.

Portal hypertension is the most important complication of a great variety of both acute and chronic liver diseases. Nevertheless, hepatic cirrhosis is the most frequent cause of portal hypertension. Gastrointestinal bleeding due to rupture of oesophageal varices is, without doubt, the most severe complication of portal hypertension. At present, great advances are being made in the pathophysiology and in the development of new therapeutic tools for controlling and preventing this severe clinical event.

This book contains the papers presented and discussed during the Symposium on 'Portal Hypertension in the 21st Century', held in Montreal, Canada, in April 2004, and sponsored by Axcan Pharma Inc. and NicOx S.A. There are eight sections covering basic mechanisms, new drugs, prevention and current treatment of variceal bleeding, prevention of recurrent bleeding and hepatic hemodynamic monitoring.

An international faculty of authors have contributed chapters at an outstanding scientific level which will be vital reading for scientists and clinicians alike."

Inhaltsubersicht - Teil 2 Klinik und Praxis.- 6 Medizinsoziologische Aspekte der Krankheit.- 7 Krankheitsausloesung - Krankheitsverarbeitung.- 8 Psychologische Bedingungen bestimmter Krankheiten.- 9 Die Arzt-Patient-Beziehung.- 10 Sondersituationen des Krankseins.- Praktisches psychosoziales Handeln.- Sachregister - Namensregister.

In this prodigiously researched study, the author concentrates on the reaction to the trials by various segments of the American public largely in terms of the legality of the tribunal, the composition of the court, the justice of the verdicts, and the implications for the future.
A UNC Press Enduring Edition -- UNC Press Enduring Editions use the latest in digital technology to make available again books from our distinguished backlist that were previously out of print. These editions are published unaltered from the original, and are presented in affordable paperback formats, bringing readers both historical and cultural value.

Nearly 2,400 Americans die of cardiovascular disease each day, an average of one death every 36 seconds. Cardiovascular disease claims more lives each year than cancer, chronic lower respiratory diseases, accidents and diabetes mellitus combined. This book summarises the available evidence comparing the efficacy and safety of using ACE inhibitors, ARBs, or their combination vs. standard medical therapy in a population with stable ischemic heart disease, or an ischemic heart disease risk equivalent, and preserved left ventricular function.

The ""final offensive,"" an insurgent campaign fought after El Salvador's coup of 1979, clearly demonstrated the strengths, weaknesses, idiosyncrasies, and behaviour of the Salvadoran officer corps. During this crucial period, the military institution faced the double threat of internal politics and a rebel guerrilla army. Colonel Bosch served as the U.S. Embassy's Defense and Army Attache during the crisis. His intimate perspective brings to life the important political and military events before, during and after the final offensive. His book gives an historical perspective as well, tracing the development of officer attitudes from 1931 to 1979. The Armed Forces political crisis of 1979 and 1980 is discussed, followed by a detailed recounting of the offensive itself. The results of the offensive are analysed, including the short-lived cohesiveness shown by the officer corps and the divisiveness that lasted through the war and into peace. The text is complemented by a map and photographs.

What gives beauty such fascinating power? Why is beauty so easy to recognize but so hard to define? Across cultures and continents and over the centuries the standards of beauty have changed but the desire to portray beauty, to praise beauty, and to possess beauty has never diminished. "Icons of Beauty" offers an enthralling overview of the most revered icons of female beauty in world art from pre-history to the present.

From images of Eve to Cindy Sherman's self-portraits, from Cleopatra to Madonna, from ancient goddesses to modern celebrities, this interdisciplinary set offers fresh insight as to how we can use perceptions of beauty to learn about world cultures, both past and present. Each chapter looks at an individual work of art to pose a question about the power of beauty. What makes beauty modern? What is the influence of celebrities? How do women portray their own beauty in a different manner than men? In-depth profiles of the icons reveal how specific ideas about beauty were developed and expressed, offering a full analysis of their history, cultural significance, and lasting influence. In addition to renowned works of art, "Icons of Beauty" also looks at icons in literature, film, politics, and contemporary entertainment.

Interdisciplinary and multicultural in its approach, chapters inside this set also feature sidebars on provocative topics and issues, such as foot binding and body adornment; myths and practices; opinions and interpretations; and even related films, songs, and even comic book characters. Generously illustrated, this rich set encompasses history, politics, society, women's studies, and art history, making it an indispensable resource for high school and college students as well as general readers.

Following the 1961 assassination of dictator Rafael Leonidas Trujillo, the Dominican Republic descended into a period of national turmoil and political instability, culminating in 1965 when a catastrophic civil war engulfed the capital city of Santo Domingo. The intervention of foreign troops, particularly U.S. troops, played a critical role in the multinational effort to establish a new leader in Joaquin Balaguer, a skillful civilian leader who defeated both a right wing coup and a Cuban - based guerrilla expedition, and successfully gained control of the chaotic Dominican Republic officer corps by the mid - 1970s. In this comprehensive study of the Dominican Republic's Balaguer era, the author draws upon declassified military documents and his own experiences as an army attache to the U.S. Embassy, Dominican Republic, during the early 1970s. The result is a unique, inside look at Balaguer's presidency, his skillful manipulation of rival officers and cliques, and American involvement in the political history of the Dominican Republic.