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100   $a20071101d2007      uy             0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 10$aStatistical issues in drug development /$fStephen Senn
205   $a2nd edition.
210   $aChichester, England ;$aHoboken, NJ $cJohn Wiley & Sons$dc2007
215   $a1 online resource (522 p.)
225 1 $aStatistics in practice
300   $aDescription based upon print version of record.
311   $a0-470-01877-1 
320   $aIncludes bibliographical references and index.
327   $aA brief and superficial history of statistics for drug developers -- Design and interpretation of clinical trials as seen by a statistician -- Probability, Bayes, P-values, tests of hypotheses, and confidence intervals -- The work of the pharmaceutical statistician -- Allocating treatments to patients in clinical trials -- Baselines and covariate information --
327   $aThe measurement of treatment effects -- Demographic subgroups : representation and analysis -- Multiplicity -- Intention to treat, missing data and related matters -- One-sided and two-sided tests and other issues to do with significance and P-values -- Determining the sample size -- Multicentre trials -- Active control equivalence studies --
327   $aMeta-analysis -- Cross-over trials -- n-of-1 trials -- Sequential trials -- Dose-finding -- Concerning pharmacokinetics and pharmacodynamics -- Bioequivalence studies -- Safety data, harms, drug monitoring, and pharmaco-epidemiology -- Pharmaco-economics and portfolio management -- Concerning pharmacogenetics, pharmacogenomics, and related matters.
330 0 $aDrug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes.  Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug
410  0$aStatistics in practice.
606   $aDrug development$xStatistical methods
615  0$aDrug development$xStatistical methods.
676   $a615/.190727
700   $aSenn$b Stephen$0116896
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910784775903321
996   $aStatistical issues in drug development$9692699
997   $aUNINA