This handbook provides an overview of up-to-date statistical methods required for design, monitoring and analysis for dose finding clinical trials, focusing both on the clinical aspects as well as statistical considerations. This book will not cover statistical methods for Phase II non-dose finding studies or Phase III clinical trials.
This handbook provides an overview of up-to-date statistical methods required for design, monitoring and analysis for dose finding clinical trials, focusing both on the clinical aspects as well as statistical considerations. This book will not cover statistical methods for Phase II non-dose finding studies or Phase III clinical trials.
Part I. Introduction to the objectives of Phase I studies and endpoints. Overview of Phase I designs. Model based designs when safety is the primary aim. Using non binary endpoints. Dose expansion cohorts. Part II. Safety and Efficacy: bivariate endpoints. Combination studies. Studies with multiple schedules. Studies in the presence of patient heterogeneity. Pediatrics. Parameterization: model complexity and optimal designs. Part III. Dose-Finding Trials in Phase II-Overview and Objectives. Analysis of Confirmatory Dose-Finding Studies. Design of dose-finding trials: Doses, allocation weights and sample size. The MCP-Mod methodology: Practical Considerations and the DoseFinding R package. Two-stage designs for dose-finding studies. Longitudinal approaches for dose-response modelling. Regulatory Viewpoint on Dose-Finding Studies. Part IV. Introduction to Pharmacometrics: Exposure Response Modeling. Pharmacokinetic Data Structure. Pharmacokinetic Compartment Modeling. Approximate Likelihood Approaches for Pharmacometrics. Population Pharmacokinetics. Pharmacodynamic Models Bayesian Approaches for Pharmacometric Modeling. Pharmacometrics Modeling Examples.
Part I. Introduction to the objectives of Phase I studies and endpoints. Overview of Phase I designs. Model based designs when safety is the primary aim. Using non binary endpoints. Dose expansion cohorts. Part II. Safety and Efficacy: bivariate endpoints. Combination studies. Studies with multiple schedules. Studies in the presence of patient heterogeneity. Pediatrics. Parameterization: model complexity and optimal designs. Part III. Dose-Finding Trials in Phase II-Overview and Objectives. Analysis of Confirmatory Dose-Finding Studies. Design of dose-finding trials: Doses, allocation weights and sample size. The MCP-Mod methodology: Practical Considerations and the DoseFinding R package. Two-stage designs for dose-finding studies. Longitudinal approaches for dose-response modelling. Regulatory Viewpoint on Dose-Finding Studies. Part IV. Introduction to Pharmacometrics: Exposure Response Modeling. Pharmacokinetic Data Structure. Pharmacokinetic Compartment Modeling. Approximate Likelihood Approaches for Pharmacometrics. Population Pharmacokinetics. Pharmacodynamic Models Bayesian Approaches for Pharmacometric Modeling. Pharmacometrics Modeling Examples.
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