Statistical Issues in Drug Development

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9780470018774: Statistical Issues in Drug Development

Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes.

Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. 

This highly readable second edition has been updated to include:

  • Comprehensive coverage of the design and interpretation of clinical trials.
  • Expanded sections on missing data, equivalence, meta-analysis and dose finding.
  • An examination of both Bayesian and frequentist methods.
  • A new chapter on pharmacogenomics and expanded coverage of pharmaco-epidemiology and pharmaco-economics.
  • Coverage of the ICH guidelines, in particular ICH E9, Statistical Principles for Clinical Trials.

It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component.

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From the Publisher:

This book for non-statisticians explains the statistical issues in drug development to help them plan, analyze and interpret clinical trials. It also examines the commercial pressures, regulatory standards and high scrutiny that accompany this field.

About the Author:

Stephen Senn has worked for the NHS in England, as a lecturer in Scotland and in drug development in Switzerland (with CIBA-Geigy). Until recently he was Professor of Pharmaceutical and Health Statistics at University College London but since September 2003 he has been  Professor of Statistics at Glasgow University. His books, Cross-over Trials in Clinical Research (1993, 2nd edition 2002) and Statistical Issues in Drug Development (1997) are published by Wiley and his latest book, Dicing with Death (2003) by Cambridge University Press. In 2001, he was the first recipient of the George C Challis award for biostatistics of the University of Florida. He is a member of the editorial boards of Statistics in Medicine, Statistical Methods in Medical Research, Pharmaceutical Statistics and Applied Clinical Trials and is a section editor for the Wiley Statistics in Practice series.

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Stephen S. Senn
Editorial: John Wiley and Sons Ltd, United States (2008)
ISBN 10: 0470018771 ISBN 13: 9780470018774
Nuevos Tapa dura Cantidad: 1
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The Book Depository
(London, Reino Unido)
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Descripción John Wiley and Sons Ltd, United States, 2008. Hardback. Estado de conservación: New. 2nd Revised edition. Language: English . Brand New Book. Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. This highly readable second edition has been updated to include:* Comprehensive coverage of the design and interpretation of clinical trials.* Expanded sections on missing data, equivalence, meta-analysis and dose finding.* An examination of both Bayesian and frequentist methods.* A new chapter on pharmacogenomics and expanded coverage of pharmaco-epidemiology and pharmaco-economics.* Coverage of the ICH guidelines, in particular ICH E9, Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component. Nº de ref. de la librería AAH9780470018774

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Descripción Wiley 2008-01-01, Hoboken, N.J. :|Chichester, 2008. hardback. Estado de conservación: New. Nº de ref. de la librería 9780470018774

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Stephen S. Senn
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Descripción John Wiley and Sons Ltd, United States, 2008. Hardback. Estado de conservación: New. 2nd Revised edition. Language: English . Brand New Book. Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. This highly readable second edition has been updated to include:* Comprehensive coverage of the design and interpretation of clinical trials.* Expanded sections on missing data, equivalence, meta-analysis and dose finding.* An examination of both Bayesian and frequentist methods.* A new chapter on pharmacogenomics and expanded coverage of pharmaco-epidemiology and pharmaco-economics.* Coverage of the ICH guidelines, in particular ICH E9, Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component. Nº de ref. de la librería AAH9780470018774

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Descripción Wiley-Interscience, 2008. Hardcover. Estado de conservación: New. 2. Nº de ref. de la librería DADAX0470018771

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