TY  - BOOK
AU  - Kay,R.
TI  - Statistical thinking for non-statisticians in drug regulation
SN  - 9781118470978 (ePub)
AV  - R853.C55 
U1  - 615.5/80724 23
PY  - 2015///
CY  - Chichester, West Sussex, UK, Hoboken, New Jersey
PB  - Wiley Blackwell
KW  - Clinical Trials as Topic
KW  - methods
KW  - Drug Approval
KW  - Drug Industry
KW  - Statistics as Topic
KW  - Clinical trials
KW  - Statistical methods
KW  - Drugs
KW  - Testing
KW  - Drug approval
KW  - Pharmaceutical industry
KW  - MEDICAL
KW  - Pharmacology
KW  - bisacsh
KW  - Medical
KW  - Electronic books
N1  - Includes bibliographical references and index; 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
N2  - Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials.It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials.Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis.Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry
UR  - http://dx.doi.org/10.1002/9781118470961
ER  -