000			04833cam a2200673 i 4500
001			ocn880831304
003			OCoLC
005			20171030095850.0
006			m o d
007			cr |||||||||||
008			140530s2015 enk ob 001 0 eng
010			_a 2014021547
020			_a9781118470978 (ePub)
020			_a1118470974 (ePub)
020			_a9781118470992 (Adobe PDF)
020			_a1118470990 (Adobe PDF)
020			_z9781118470947 (cloth)
020			_a9781118470961
020			_a1118470966
028	0	1	_aEB00597613 _bRecorded Books
029	1		_aNZ1 _b15894508
029	1		_aDEBBG _bBV042795646
029	1		_aDEBBG _bBV043396821
035			_a(OCoLC)880831304 _z(OCoLC)896846731 _z(OCoLC)906975669 _z(OCoLC)927508433 _z(OCoLC)961566081 _z(OCoLC)962660732
040			_aDLC _beng _erda _cDLC _dYDX _dDG1 _dN$T _dYDXCP _dE7B _dRECBK _dOCLCO _dEBLCP _dDEBBG
042			_apcc
049			_aMAIN
050	0	0	_aR853.C55
060	1	0	_aQV 771.4
072		7	_aMED _x071000 _2bisacsh
082	0	0	_a615.5/80724 _223
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. _h[electronic resource]
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.
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.
588			_aDescription based on print version record and CIP data provided by publisher.
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
942			_2ddc _cBK
999			_c207476 _d207476