LEADER 04952nam 22006734a 450 001 9911019528803321 005 20200520144314.0 010 $a9786610838806 010 $a9781280838804 010 $a1280838809 010 $a9780470094778 010 $a047009477X 010 $a9780470094761 010 $a0470094761 035 $a(CKB)1000000000356511 035 $a(EBL)291277 035 $a(SSID)ssj0000111715 035 $a(PQKBManifestationID)11132983 035 $a(PQKBTitleCode)TC0000111715 035 $a(PQKBWorkID)10081136 035 $a(PQKB)11347431 035 $a(MiAaPQ)EBC291277 035 $a(OCoLC)177144400 035 $a(Perlego)2752925 035 $a(EXLCZ)991000000000356511 100 $a20060908d2007 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aBioequivalence studies in drug development $emethods and applications /$fDieter Hauschke, Volker Steinijans, Iris Pigeot 210 $aChichester, West Sussex, England ;$aHoboken, NJ $cWiley$dc2007 215 $a1 online resource (330 p.) 225 1 $aStatistics in practice 300 $aDescription based upon print version of record. 311 08$a9780470094754 311 08$a0470094753 320 $aIncludes bibliographical references and indexes. 327 $aBioequivalence Studies in Drug Development; Contents; Preface; 1 Introduction; 1.1 Definitions; 1.1.1 Bioavailability; 1.1.2 Bioequivalence; 1.1.3 Therapeutic equivalence; 1.2 When are bioequivalence studies performed; 1.2.1 Applications for products containing new active substances; 1.2.2 Applications for products containing approved active substances; 1.2.3 Applications for modified release forms essentially similar to a marketed modified release form; 1.3 Design and conduct of bioequivalence studies; 1.3.1 Crossover design and alternatives; 1.3.2 Single- vs. multiple-dose studies 327 $a1.3.3 Pharmacokinetic characteristics1.3.4 Subjects; 1.3.5 Statistical models; 1.3.5.1 Average bioequivalence; 1.3.5.2 Population bioequivalence; 1.3.5.3 Individual bioequivalence; 1.3.6 Sample size; 1.4 Aims and structure of the book; References; 2 Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies; 2.1 Introduction; 2.2 Pharmacokinetic characteristics (metrics) for single-dose studies; 2.2.1 Extent of bioavailability; 2.2.2 Rate of bioavailability; 2.3 Pharmacokinetic rate and extent characteristics (metrics) for multiple-dose studies 327 $a2.4 ConclusionsReferences; 3 Basic statistical considerations; 3.1 Introduction; 3.2 Additive and multiplicative model; 3.2.1 The normal distribution; 3.2.2 The lognormal distribution; 3.3 Hypotheses testing; 3.3.1 Consumer and producer risk; 3.3.2 Types of hypotheses; 3.3.2.1 Test for difference; 3.3.2.2 Test for superiority; 3.3.2.3 Test for noninferiority; 3.3.2.4 Test for equivalence; 3.3.3 Difference versus ratio of expected means; 3.3.3.1 The normal distribution; 3.3.3.2 The lognormal distribution; 3.4 The RT/TR crossover design assuming an additive model 327 $a3.4.1 Additive model and effects3.4.2 Parametric analysis based on t-tests; 3.4.2.1 Test for difference in carryover effects; 3.4.2.2 Test for difference in formulation effects; 3.4.2.3 Test for difference in period effects; 3.4.3 Nonparametric analysis based on Wilcoxon rank sum tests; 3.4.3.1 Test for difference in carryover effects; 3.4.3.2 Test for difference in formulation effects; 3.4.3.3 Test for difference in period effects; References; 4 Assessment of average bioequivalence in the RT/TR design; 4.1 Introduction; 4.2 The RT/TR crossover design assuming a multiplicative model 327 $a5 Power and sample size determination for testing average bioequivalence in the RT/TR design 330 $aStudies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects r 410 0$aStatistics in practice. 606 $aDrugs$xTherapeutic equivalency 615 0$aDrugs$xTherapeutic equivalency. 676 $a615/.19 700 $aHauschke$b Dieter$01842432 701 $aSteinijans$b Volker$01842433 701 $aPigeot$b Iris$01842434 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9911019528803321 996 $aBioequivalence studies in drug development$94422553 997 $aUNINA