Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk


Book Description

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)




Moments in Mathematics


Book Description

Function theory, spectral decomposition of operators, probability, approximation, electrical and mechanical inverse problems, prediction of stochastic processes, the design of algorithms for signal-processing VLSI chips--these are among a host of important theoretical and applied topics illuminated by the classical moment problem. To survey some of these ramifications and the research which derives from them, the AMS sponsored the Short Course Moments in Mathematics at the Joint Mathematics Meetings, held in San Antonio, Texas, in January 1987. This volume contains the six lectures presented during that course. The papers are likely to find a wide audience, for they are expository, but nevertheless lead the reader to topics of current research. In his paper, Henry J. Landau sketches the main ideas of past work related to the moment problem by such mathematicians as Caratheodory, Herglotz, Schur, Riesz, and Krein and describes the way the moment problem has interconnected so many diverse areas of research. J. H. B. Kemperman examines the moment problem from a geometric viewpoint which involves a certain natural duality method and leads to interesting applications in linear programming, measure theory, and dilations. Donald Sarason first provides a brief review of the theory of unbounded self-adjoint operators then goes on to sketch the operator-theoretic treatment of the Hamburger problem and to discuss Hankel operators, the Adamjan-Arov-Krein approach, and the theory of unitary dilations. Exploring the interplay of trigonometric moment problems and signal processing, Thomas Kailath describes the role of Szego polynomials in linear predictive coding methods, parallel implementation, one-dimensional inverse scattering problems, and the Toeplitz moment matrices. Christian Berg contrasts the multi-dimensional moment problem with the one-dimensional theory and shows how the theory of the moment problem may be viewed as part of harmonic analysis on semigroups. Starting from a historical survey of the use of moments in probability and statistics, Persi Diaconis illustrates the continuing vitality of these methods in a variety of recent novel problems drawn from such areas as Wiener-Ito integrals, random graphs and matrices, Gibbs ensembles, cumulants and self-similar processes, projections of high-dimensional data, and empirical estimation.




Poland After Solidarity


Book Description

The unexpected emergence of the Solidarity movement in Poland has focused Western attention on conflicts within socialist states. The rapid truncation of Solidarity and the rise of a new image of the state as a militarized, relatively autonomous, repressive apparatus has left several theoretical questions unresolved and raised some new ones. This volume draws from historical and political accounts of the events that haunted Poland between 1980 and 1984, providing a complex sociological explanation of the major processes that occur within the state-society sphere of relationships. In part one, the authors examine the conflict between social movements and the state in Poland: the history of Solidarity, the nature of the political conflict between Solidarity and the Communist state, the institutionaliza-tion of the means of control by the party over society, the functioning of civil society, and the mediating role of the Catholic Church. In part two, the authors treat issues that go beyond Solidarity: the scope of state autonomy, legitimacy conflicts within socialist and capitalist states, other social movements in Poland, and the philosophical symbolism of Solidarity.




Women and Disability


Book Description

The special needs of women with disabilities have been disregarded in a wide variety of vital areas. Issues pertain to women as wives and mothers. Studies of the effects on female sexuality of such conditions as renal disease and diabetes are lacking, though the sexual functioning of men with these diseases has been researched. On the economic front, the Federal-State Vocational Rehabilitation system and the regulations concerning disability benefits under Social Security provide less adequately for women than for men. Hopefully, this volume will raise the consciousness of its readers to the special status of women with disabilities as a minority group experiences multiple sources of discriminations.







Discrete Thoughts


Book Description

This is a volume of essays and reviews that delightfully explores mathematics in all its moods — from the light and the witty, and humorous to serious, rational, and cerebral. These beautifully written articles from three great modern mathematicians will provide a source for supplemental reading for almost any math class. Topics include: logic, combinatorics, statistics, economics, artificial intelligence, computer science, and broad applications of mathematics. Readers will also find coverage of history and philosophy, including discussion of the work of Ulam, Kant, and Heidegger, among others.




Lie Algebras and Related Topics


Book Description

As the Proceedings of the 1984 Canadian Mathematical Society's Summer Seminar, this book focuses on some advances in the theory of semisimple Lie algebras and some direct outgrowths of that theory. The following papers are of particular interest: an important survey article by R. Block and R. Wilson on restricted simple Lie algebras, a survey of universal enveloping algebras of semisimple Lie algebras by W. Borho, a course on Kac-Moody Lie algebras by I. G. Macdonald with an extensive bibliography of this field by Georgia Benkart, and a course on formal groups by M. Hazewinkel. Because of the expository surveys and courses, the book will be especially useful to graduate students in Lie theory, as well as to researchers in the field.




Combinatorial Methods in Topology and Algebraic Geometry


Book Description

A survey of the areas where combinatorial methods have proven especially fruitful: topology and combinatorial group theory, knot theory, 3-manifolds, homotopy theory and infinite dimensional topology, and four manifolds and algebraic surfaces.




The Magic Drum and Other Favourite Stories


Book Description

A princess thinks she was a bird, a coconut that cost a thousand rupees, and a shepherd with a bag of words...Kings and misers, princes and paupers, wise men and foolish boys, the funniest and oddest men and women come alive in this sparkling new collection of stories. The clever princess will only marry the man who can ask her a question she cannot answer; the orphan boy outwits his greedy uncles with a bag of ash; and an old couple in distress is saved by a magic drum. Sudha Murty's grandparents told her some of these stories when she was a child; others she heard from her friends from around the world. These delightful and timeless folktales have been her favourites for years, and she has recounted them many times over to the young people in her life. With this collection, they will be enjoyed by many more readers, of all ages. Age group of target audience is 8+.