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

Format:

Book

Author/Creator:

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

Language:

English

Subjects (All):

Drugs--Testing.

Drugs.

Drugs--Design.

Physical Description:

1 online resource (370 p.)

Edition:

Second edition.

Place of Publication:

Chichester, England : Wiley Blackwell, 2015.

Language Note:

English

Summary:

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

Contents:

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.

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on print version record.

ISBN:

9781118470978

1118470974

9781118470992

1118470990

9781118470961

1118470966

OCLC:

906188339