Statistical thinking for non-statisticians in drug regulation

by Kay, R., (Richard)

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Title Statements

Full title :Statistical thinking for non-statisticians in drug regulation / Richard Kay.

Edition Statements

Publication Date:2015.
Edition:Second edition

Publication Statements

Publisher(s):John Wiley & Sons, Inc
Place of Publication:Chichester, West Sussex, UK
Language:eng
Publication Date:2015.

The Physical Object

Description:xxii, 346 pages : : illustrations ; : 26 cm

Edition Identifiers

ISBN:9781118470947, 111847094X
oclc:ocn880685452
LC Classification:R853.C55
Dewey Decimal:615.5/80724

Basic ideas in clinical trial design -- Sampling and inferential statistics -- Confidence intervals and p-values -- Tests for simple treatment comparisons -- Adjusting the analysis -- Regression and analysis of covariance -- Intention-to-treat and analysis sets -- Power and sample size -- Statistical significance and clinical importance -- Multiple testing -- Non-parametric and related methods -- Equivalence and non-inferiority -- The analysis of survival data -- Interim analysis and data monitoring committees -- Bayesian statistics -- Adaptive designs -- Observational studies -- Meta-analysis -- Methods for the safety analysis and safety monitoring -- Diagnosis -- The role of statistics and statisticians.

Subjects

Clinical trials -- Statistical methods Clinical Trials as Topic -- methods Drug Approval Drug approval -- Statistical methods Drug Industry Drugs -- Testing Études cliniques -- Méthodes statistiqu… Industrie pharmaceutique Industrie pharmaceutique -- Méthodes st… Médicaments -- Autorisation de mise sur… Médicaments -- Essais cliniques Pharmaceutical industry Pharmaceutical industry -- Statistical … Statistics Statistics as Topic Statistiques