Statistical Issues in Drug Development
1st Edition
Published on 29. July 1997
Book
Hardback
442 pages
978-0-471-97488-8 (ISBN)
Description
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.
More details
Series
Edition
1., Aufl.
Language
English
Place of publication
Chichester
United Kingdom
Publishing group
John Wiley and Sons Ltd
Target group
College/higher education
Professional and scholarly
Illustrations
Ill.
Dimensions
Height: 23.6 cm
Width: 15.8 cm
Weight
760 gr
ISBN-13
978-0-471-97488-8 (9780471974888)
Schweitzer Classification
Other editions
New editions
Stephen S. Senn
Statistical Issues in Drug Development
Book
01/2008
2nd Edition
Wiley
Unfortunately, price unknown
Article exhausted; check for reprint
Content
Section 1: A brief history of statistics; design and interpretation of clinical trials as seen by a statistician; probability, Bayes and p-values; the work of the statistician. Section 2 - (controversial topics in drug development): allocating treatment to patients in clinical trials; using covariate information; sub-group analysis; the problem of multiplicity; concerning intention to treat; one sided and two sided tests; determining sample size; active control equivalence studies; multi-centre trials and meta-analysis; sequential trials; cross-over trials; n-of-1 trials; dose-finding; bioequivalence studies; pharmacokinetic studies; project prioritisation; statistical problems in drug monitoring.