000			04124cam a2200517 i 4500
041			_aeng
999			_c200454318 _d72530
001			1345279246
003			OCoLC
005			20241121093255.0
006			m o d
007			cr |||||||||||
008			220707s2023 nju ob 001 0 eng
020			_a9781119867401 _q(epub)
020			_a1119867401
020			_a9781119867395 _q(adobe pdf)
020			_a1119867398
020			_z9781119867388 _q(hardback)
035			_a(OCoLC)1345279246
040			_aDLC _beng _erda _cDLC _dUKAHL
060	0	0	_aQV 771.4
096			_aQV771.4
100	1		_aKay, R. _q(Richard), _d1949- _0https://id.loc.gov/authorities/names/n82119999 _eauthor
245	1	0	_aStatistical thinking for non-statisticians in drug regulation / _cRichard Kay
250			_aThird edition
264		1	_aHoboken, NJ : _bWiley-Blackwell, _c2023
300			_a1 online resource
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
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
506			_aAvailable to OhioLINK libraries
520			_aStatistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance
650		0	_aClinical trials _xStatistical methods. _0https://id.loc.gov/authorities/subjects/sh2009120433
650		0	_aDrugs _xTesting _0https://id.loc.gov/authorities/subjects/sh85039755 _xStatistical methods. _0https://id.loc.gov/authorities/subjects/sh2001008679
650		0	_aDrug approval _0https://id.loc.gov/authorities/subjects/sh2002008777 _xStatistical methods. _0https://id.loc.gov/authorities/subjects/sh2001008679
650		0	_aPharmaceutical industry _0https://id.loc.gov/authorities/subjects/sh85039713 _xStatistical methods. _0https://id.loc.gov/authorities/subjects/sh2001008679
650	1	2	_aClinical Trials as Topic _xmethods. _0https://id.nlm.nih.gov/mesh/D002986Q000379
650	1	2	_aDrug Approval. _0https://id.nlm.nih.gov/mesh/D017277
650	2	2	_aStatistics as Topic. _0https://id.nlm.nih.gov/mesh/D013223 _9117232
650	2	2	_aDrug Industry. _0https://id.nlm.nih.gov/mesh/D004345 _923084
655		0	_aElectronic books _92032
776	0	8	_iPrint version: _aKay, Richard, 1949- _tStatistical thinking for non-statisticians in drug regulation _bThird edition. _dHoboken, NJ : Wiley-Blackwell, 2023 _z9781119867388 _w(DLC) 2022032464
856	4	0	_3Wiley Online Library _zConnect to resource _uhttps://onlinelibrary.wiley.com/doi/book/10.1002/9781119867418
942			_2NLM _cEBK