Product Description

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.

Product Details

• Amazon Sales Rank: #986787 in Books
• Published on: 1997-07-29
• Original language: English
• Number of items: 1
• Binding: Hardcover
• 442 pages

Statistical Methods in Medical Research, 8, 1999
...this book is a welcome addition to the literature on statistical science in drug development. It contains a wealth of information and opinion - both theoretical and practical. It is somewhat unique in that it focuses squarely on issues, with algebraic details relegated to chapter appendices. This format will be greatly appreciated by its intended readership - scientists and statisticians working in drug development or studying medical statistics. The book will also be insightful for regulatory personnel. Every pharmaceutical company and regulatory agency should have copies of this book available for its employees. ...If you are involved in drug development and approval process, make time to read this book and consider the statistical issues contained within.

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.