Statistical Issues In Drug Development - Couverture rigide

Senn, Stephen

Couverture rigide

ISBN 10 : 0471974889 ISBN 13 : 9780471974888

Editeur : John Wiley & Sons Ltd, 1997

Synopsis

The statistical issues in drug development are explained in this book, enabling non-statistians to work more easily alongside their statistical colleagues in planning, analysing and interpreting clinical trials. The author aims to make the book of particularly benefit to the physician who might have little access to statistical expertise. Drug development brings its own commercial pressures whilst regulatory standards determine that much of the work is examined very closely. As a consequence, the non-statistician working in drug development has to possess considerable appreciation of statistical issues, and this book aims to provide that.

A propos du livre

Revue de presse

For all his contributions to the development and exposition of medical statistics Stephen Senn is awarded the 2009 Bradford Hill Medal by the Royal Statistical Society.

?This book is a thought provoking, intriguing, and often challenging read. The author is unafraid to tackle weighty philosophical and paradigmatic issues, and he generally does so with great skill and insight. ...this excellent book should serve to inspire both statisticians and life scientists.? (Journal of the American Statistical Association, September 2009)

"For statisticians, this should be required reading for anyone considering or starting out on a career in clinical drug development. I am also quite sure that most experienced statisticians would find this a useful book to dip into on occasion ... . This book will not disappoint." (Journal of the Royal Statistical Society: Series A (Statistics in Society), April 2009)

"This book is an outstanding effort from a statistician of heroic proportions. Someone like me is only capable of sitting on the curb and applauding wildly." (Journal of Biopharmaceutical Statistics, Volume 19, Issue 1, 2009)

For all his contributions to the development and exposition of medical statistics Stephen Senn is awarded the 2009 Bradford Hill Medal by the Royal Statistical Society.

"This book is an outstanding effort from a statistician of heroic proportions.  Someone like me is only capable of sitting on the curb and applauding wildly." (Journal of Biopharmaceutical Statistics, Volume 19, Issue 1, 2009)

"For statisticians, this should be required reading for anyone considering or starting out on a career in clinical drug development. I am also quite sure that most experienced statisticians would find this a useful book to dip into on occasion ... . This book will not disappoint." (Journal of the Royal Statistical Society: Series A (Statistics in Society), April 2009)

Présentation de l'éditeur

Statistics in Practice A new series of practical books outlining the use of statistical techniques in a wide range of application areas:
∗ Human and Biological Sciences
∗ Earth and Environmental Sciences
∗ Industry, Commerce and Finance
Statistical Issues in Drug Development Stephen Senn Professor of Pharmaceutical & Health Statistics, University College, London Statistical Issues in Drug Development provides an accessible text for those working directly in drug development, regulatory and marketing departments within the pharmaceutical industry. As a consequence of regulatory authorities demanding increasingly higher standards, statistics has become a critical element in the design and conduct of drug development programmes. The concepts covered in this volume guide the non–statistician through the most pressing statistical issues and controversies in drug development. Key issues covered include:
∗ Design & interpretation of clinical trials
∗ Bayesian & frequentist methods
∗ Sequential & cross–over trials
∗ Drug monitoring & pharmaco–economics
The book has been prepared in two sections. The first section considers the role of statistics in drug development from four different perspectives: historical, philosophical, technical and professional. The second section covers a series of controversial topics such as fixed versus random effects for meta–analysis, one–sided versus two–sided tests and the ethics of placebo run–ins. The approachable and wide–ranging coverage of this book will make it invaluable to all those working in drug development and regulation.

Détails de l'édition

• Éditeur: John Wiley & Sons Ltd
• Date d'édition: 1997
• Langue: anglais
• ISBN 10: 0471974889
• ISBN 13: 9780471974888
• Reliure: Relié
• Nombre de pages: 442
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible