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| 001 | ocn880831304 | ||
| 003 | OCoLC | ||
| 005 | 20171224114638.0 | ||
| 006 | m o d | ||
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| 008 | 140530s2015 enk ob 001 0 eng | ||
| 010 | _a 2014021547 | ||
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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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_a615.5/80724 _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. |
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| 300 | _a1 online resource. | ||
| 336 |
_atext _2rdacontent |
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| 337 |
_acomputer _2rdamedia |
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| 338 |
_aonline resource _2rdacarrier |
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| 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. |
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| 650 | 0 |
_aDrugs _xTesting _xStatistical methods. |
|
| 650 | 0 |
_aDrug approval _xStatistical methods. |
|
| 650 | 0 |
_aPharmaceutical industry _xStatistical methods. |
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| 650 | 7 |
_aMEDICAL _xPharmacology. _2bisacsh |
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| 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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