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Statistical thinking for non-statisticians in drug regulation /

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 in...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Kay, R. (Richard), 1949- (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Chichester, West Sussex, UK ; Hoboken, NJ, USA : John Wiley & Sons Inc., 2015.
Edición:Second edition.
Temas:
Acceso en línea:Texto completo

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049 |a UAMI 
100 1 |a Kay, R.  |q (Richard),  |d 1949-  |e author.  |1 https://id.oclc.org/worldcat/entity/E39PCjxb3f9v36xCGQ3FP8VtDm 
245 1 0 |a Statistical thinking for non-statisticians in drug regulation /  |c Richard Kay. 
250 |a Second edition. 
264 1 |a Chichester, West Sussex, UK ;  |a Hoboken, NJ, USA :  |b John Wiley & Sons Inc.,  |c 2015. 
300 |a 1 online resource (xiv, 346 pages) :  |b illustrations 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
504 |a Includes bibliographical references and index. 
505 0 |a 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. 
520 |a 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. 
590 |a ProQuest Ebook Central  |b Ebook Central Academic Complete 
650 0 |a Pharmaceutical industry  |x Statistical methods. 
650 0 |a Drug approval  |x Statistical methods. 
650 0 |a Drugs  |x Testing  |x Statistical methods. 
650 0 |a Clinical trials  |x Statistical methods. 
650 0 |a Statistics. 
650 0 |a Pharmaceutical industry. 
650 2 |a Drug Approval 
650 2 |a Clinical Trials as Topic  |x methods 
650 2 |a Statistics as Topic 
650 2 |a Drug Industry 
650 6 |a Industrie pharmaceutique  |x Méthodes statistiques. 
650 6 |a Médicaments  |x Autorisation de mise sur le marché  |x Méthodes statistiques. 
650 6 |a Médicaments  |x Essais cliniques  |x Méthodes statistiques. 
650 6 |a Études cliniques  |x Méthodes statistiques. 
650 6 |a Statistiques. 
650 6 |a Industrie pharmaceutique. 
650 6 |a Statistique. 
650 7 |a statistics.  |2 aat 
650 7 |a MEDICAL  |x Pharmacology.  |2 bisacsh 
650 7 |a Statistics  |2 fast 
650 7 |a Pharmaceutical industry  |2 fast 
650 7 |a Clinical trials  |x Statistical methods  |2 fast 
650 7 |a Drugs  |x Testing  |x Statistical methods  |2 fast 
650 7 |a Pharmaceutical industry  |x Statistical methods  |2 fast 
776 0 8 |i Print version:  |a Kay, Richard.  |t Statistical Thinking for Non-Statisticians in Drug Regulation.  |d Hoboken : Wiley, ©2014  |z 9781118470947 
856 4 0 |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=1824197  |z Texto completo 
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