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020 _a9781118470978 (ePub)
020 _a1118470974 (ePub)
020 _a9781118470992 (Adobe PDF)
020 _a1118470990 (Adobe PDF)
020 _z9781118470947 (cloth)
020 _a9781118470961
020 _a1118470966
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_223
049 _aMAIN
100 1 _aKay, R.
_q(Richard),
_d1949-
_eauthor.
245 1 0 _aStatistical thinking for non-statisticians in drug regulation /
_cRichard Kay, PhD, Statistical Consultant, RK Statistics Ltd, Honorary Visiting Professor, School of Pharmacy, Cardiff University, UK.
250 _aSecond edition.
264 1 _aChichester, West Sussex, UK ;
_aHoboken, New Jersey :
_bWiley Blackwell,
_c2015.
300 _a1 online resource.
336 _atext
_2rdacontent
337 _acomputer
_2rdamedia
338 _aonline resource
_2rdacarrier
504 _aIncludes bibliographical references and index.
505 0 _aBasic 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.
588 _aDescription based on print version record and CIP data provided by publisher.
520 _aStatistical 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.
650 2 _aClinical Trials as Topic
_xmethods.
650 2 _aDrug Approval.
650 2 _aDrug Industry.
650 2 _aStatistics as Topic.
650 0 _aClinical trials
_xStatistical methods.
650 0 _aDrugs
_xTesting
_xStatistical methods.
650 0 _aDrug approval
_xStatistical methods.
650 0 _aPharmaceutical industry
_xStatistical methods.
650 7 _aMEDICAL
_xPharmacology.
_2bisacsh
650 4 _aMedical.
655 4 _aElectronic books.
655 0 _aElectronic books.
776 0 8 _iPrint version:
_aKay, R. (Richard), 1949- author.
_tStatistical thinking for non-statisticians in drug regulation
_bSecond edition.
_dChichester, West Sussex, UK ; Hoboken, NJ, USA : John Wiley & Sons Inc., 2015
_z9781118470947
_w(DLC) 2014020541
856 4 0 _uhttp://onlinelibrary.wiley.com/book/10.1002/9781118470961
_zWiley Online Library
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