Statistical thinking for non-statisticians in drug regulation
by
 
Kay, R. (Richard), 1949- author.

Title
Statistical thinking for non-statisticians in drug regulation

Author
Kay, R. (Richard), 1949- author.

ISBN
9781119867418
 
9780470513255
 
9781118451885

Physical Description
1 online resource (xviii, 276 pages) : illustrations.

Contents
Statistical Thinking for Non-Statisticians in Drug Regulation; Contents; Preface; Abbreviations; 1 Basic ideas in clinical trial design; 2 Sampling and inferential statistics; 3 Confidence intervals and p-values; 4 Tests for simple treatment comparisons; 5 Multi-centre trials; 6 Adjusted analyses and analysis of covariance; 7 Intention-to-treat and analysis sets; 8 Power and sample size; 9 Statistical significance and clinical importance; 10 Multiple testing; 11 Non-parametric and related methods; 12 Equivalence and non-inferiority; 13 The analysis of survival data.

Abstract
"This book presents the statistical methods employed by the pharmaceutical industry in relation to current regulatory requirements. It explains them in ways that are easily understandable by providing an insight into their interpretation and the context in which they are used." "Those working within the pharmaceutical industry, including: physicians, investigators, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers, and those working in quality assurance will find this book a valuable learning tool on statistics."--BOOK JACKET.

Local Note
John Wiley and Sons

Subject Term
Clinical trials -- Statistical methods.
 
Drugs -- Testing -- Statistical methods.
 
Drug approval -- Statistical methods.
 
Pharmaceutical industry -- Statistical methods.
 
Statistics.
 
Pharmaceutical industry.
 
Clinical Trials as Topic -- methods
 
Statistics as Topic
 
Drug Approval
 
Drug Industry
 
Études cliniques -- Méthodes statistiques.
 
Médicaments -- Essais cliniques -- Méthodes statistiques.
 
Médicaments -- Autorisation de mise sur le marché -- Méthodes statistiques.
 
Industrie pharmaceutique -- Méthodes statistiques.
 
Statistiques.
 
Industrie pharmaceutique.
 
Statistique.
 
MEDICAL -- Chemotherapy.
 
Statistics
 
Pharmaceutical industry
 
Clinical trials -- Statistical methods
 
Drugs -- Testing -- Statistical methods
 
Pharmaceutical industry -- Statistical methods

Electronic Access
https://onlinelibrary.wiley.com/doi/book/10.1002/9781118451885
 
https://onlinelibrary.wiley.com/doi/book/10.1002/9781119867418


LibraryMaterial TypeItem BarcodeShelf Number[[missing key: search.ChildField.HOLDING]]Status
Online LibraryE-Book598151-1001R853 .C55 K39 2007Wiley E-Kitap Koleksiyonu