Statistical Issues in Drug Development (Statistics in Practice) - Hardcover

Book 47 of 49: Statistics in Practice

Senn, Stephen S.

 
9780471974888: Statistical Issues in Drug Development (Statistics in Practice)

Synopsis

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.

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From the Back Cover

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.

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Other Popular Editions of the Same Title

9781119238577: Statistical Issues in Drug Development (Statistics in Practice)

Featured Edition

ISBN 10:  1119238579 ISBN 13:  9781119238577
Publisher: Wiley, 2021
Hardcover