Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials

Herausgeber: O'Quigley, John; Bornkamp, Björn; Iasonos, Alexia

• Gebundenes Buch

Produktbeschreibung

"A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc."

Produktdetails

• Chapman & Hall/CRC Handbooks of Modern Statistical Methods
• Verlag: Taylor & Francis Inc
• Seitenzahl: 320
• Erscheinungstermin: 25. April 2017
• Englisch
• Abmessung: 251mm x 183mm x 23mm
• Gewicht: 804g
• ISBN-13: 9781498746106
• ISBN-10: 1498746101
• Artikelnr.: 48453806

Autorenporträt

O'Quigley, John; Iasonos, Alexia; Bornkamp, Björn

Inhaltsangabe

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.