Bioequivalence and Statistics in Clinical Pharmacology

CRC Press
  • 2. Auflage
  • |
  • erscheint ca. am 31. März 2021
  • Buch
  • |
  • Softcover
  • |
  • XXVI, 434 Seiten
978-0-367-78244-3 (ISBN)
Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials.Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.
  • Englisch
  • London
  • |
  • Großbritannien
Taylor & Francis Ltd
  • Für höhere Schule und Studium
  • Neue Ausgabe
  • Höhe: 254 mm
  • |
  • Breite: 178 mm
978-0-367-78244-3 (9780367782443)
weitere Ausgaben werden ermittelt
Scott D. Patterson, Byron Jones
Bioequivalence & Biopharmaceutical DevelopmentDrug Development and Clinical PharmacologyAims of This BookBiopharmaceutical DevelopmentClinical PharmacologyStatistics in Clinical PharmacologyStructure of the BookHistory and Regulation of BioequivalenceWhen and How BE Studies Are PerformedWhy Are BE Studies Performed?Deciding When Formulations Are BioequivalentPotential Issues with TOST BioequivalentCurrent International RegulationSome Practical NotesTesting for Average BioequivalenceBackgroundLinear Model for 2 x 2 DataApplying the TOST ProcedureCarry-over, Sequence, and Interaction EffectsChecking Assumptions Made about the Linear ModelPower and Sample Size for ABE in the 2 x 2 DesignExample Where Test and Reference Are Not ABENonparametric AnalysisBE Studies with More Than Two PeriodsBackgroundThree-period DesignsWithin-subject VariabilityRobust Analyses for Three Period DesignsFour-period DesignsDesignes with More Than Two TreatmentsAdjusting for Multiple TestingNonparametric Analyses of TmaxTechnical appendix: EfficiencyTables of DataSpecial Topics in BioequivalenceDealing with Special BE ChallengesRestricted Maximum Likelihood ModellingFailing BE and the DER AssessmentSimulationData-based SimulationCarry-overOptimal DesignsDetermining Trial SizeWhat Outliers Are and How to Handle Their DataBayesian BE AssessmentAdaptive Bioequivalence TrialsBackgroundTwo-stage design for testing for ABETOST using the standard combination testExample of using the standard combination testThe maximum combination testExample of using the maximum combination testConditional errors and conditional powerAlgorithm for sample size re-estimationOperating characteristicsConclusionsTechniccal Appendix: R codeScaled Average Bioequivalence TestingBackgroundScaled Average Bioequivalence in EuropeScaled Average Bioequivalence in USADiscussion and CautionsClinical PharmacologyClinical Pharmacology Safety StudiesBackgroundFirst-time-in-humansSub-chronic Dosing StudiesFood-Effect Assessment and DDIsDose-ProportionalityTechnical AppendixQTcBackgroundModelling of QTc DataInterpreting the QTc Modelling FindingsDesign of a Thorough QTc Study in the FutureClinical Pharmacology Efficacy StudiesBackgroundSub-chronic DosingPhase IIa and the Proof of ConceptPopulation PharmacokineticsPopulation and PharmacokineticsAbsolute and Relative Bioavailabili

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