LEADER 03525nam 2200481 450 001 9910830834503321 005 20230629222857.0 010 $a1-119-23859-5 010 $a1-119-23860-9 010 $a1-119-23861-7 035 $a(CKB)4330000000009501 035 $a(MiAaPQ)EBC6630971 035 $a(Au-PeEL)EBL6630971 035 $a(OCoLC)1255220698 035 $a(EXLCZ)994330000000009501 100 $a20220130d2021 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aStatistical issues in drug development /$fStephen Senn 205 $aThird edition. 210 1$aHoboken, New Jersey ;$aWest, Sussex, England :$cWiley Blackwell,$d[2021] 210 4$dİ2021 215 $a1 online resource (643 pages) 225 1 $aStatistics in practice 311 $a1-119-23857-9 320 $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 -- The 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 -- Meta-Analysis -- Cross-over Trials -- n-of-1 Trials -- Sequential Trial -- 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 $a"This will be the third edition of Statistical Issues in Drug Development, and will be fully revised and updated to include information on the latest industry standards and guidelines. Both the first (1997) and second (2007) editions were very well received and the book has become a standard. This book is unique in providing a thorough and critical discussion of the most important and controversial issues encountered by statisticians and their life scientist colleagues on both sides of the regulatory divide in drug development. The primary purpose of the book is to encourage and facilitate discussion between statisticians and their colleagues of the many complex statistical issues that arise in drug development. The book will be suitable as a course of self-instruction for statisticians who are new to the pharmaceutical industry, either because of recent graduation or change of career. It will also act as an authoritative reference for those working in drug development, and provide possible topics for discussion in journal forums"--$cProvided by publisher. 410 0$aStatistics in practice. 606 $aDrug development$xStatistical methods 615 0$aDrug development$xStatistical methods. 676 $a615.19 700 $aSenn$b Stephen$0116896 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910830834503321 996 $aStatistical issues in drug development$9692699 997 $aUNINA