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The Resource Statistical thinking for non-statisticians in drug regulation, Richard Kay, (electronic book)

Statistical thinking for non-statisticians in drug regulation, Richard Kay, (electronic book)

Label
Statistical thinking for non-statisticians in drug regulation
Title
Statistical thinking for non-statisticians in drug regulation
Statement of responsibility
Richard Kay
Creator
Author
Subject
Language
eng
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 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
Cataloging source
DLC
http://library.link/vocab/creatorDate
1949-
http://library.link/vocab/creatorName
Kay, R.
Dewey number
615.5/80724
Index
index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/subjectName
  • Clinical Trials as Topic
  • Drug Approval
  • Drug Industry
  • Statistics as Topic
  • Clinical trials
  • Drugs
  • Drug approval
  • Pharmaceutical industry
Label
Statistical thinking for non-statisticians in drug regulation, Richard Kay, (electronic book)
Instantiates
Publication
Bibliography note
Includes bibliographical references and index
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
Control code
ocn880831304
Edition
Second edition.
Extent
1 online resource.
Form of item
online
Isbn
9781118470947
Publisher number
EB00597613
Specific material designation
remote
Label
Statistical thinking for non-statisticians in drug regulation, Richard Kay, (electronic book)
Publication
Bibliography note
Includes bibliographical references and index
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
Control code
ocn880831304
Edition
Second edition.
Extent
1 online resource.
Form of item
online
Isbn
9781118470947
Publisher number
EB00597613
Specific material designation
remote

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