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Activity Number: 179
Type: Contributed
Date/Time: Monday, August 5, 2013 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #309969
Title: A Comparison of Different Development Strategies and Study Designs for Device-Bridging Bioequivalence Studies
Author(s): Ying "Denise" Wang*+ and Tony Sabin
Companies: Amgen and Amgen, Inc
Keywords: device ; bioequivalence ; crossover ; power ; adaptive ; sequential
Abstract:

For biologic products a well engineered drug delivery device can improve patient's experience. During the drug development process, a bioequivalence study is often required to bridge between the original pioneer device and the final commercial device. In many situations it is desirabe to use a crossover design as this eliminates major sources of study variability including between subject differences in the rates of drug absorption, clearance, and the volume of distribution. However designing such studies requires an estimate of the within subject standard deviation (SD). A study design relying on a traditional single crossover pivotal trial with limited prior information may lead to over- or under-powered trials. In this study we will present a case-study comparing the pros and cons of several study designs (including adaptive sequential and two-stage crossover) and development strategies for the situation where there is limited prior information to allow adequate estimate of the within subject SD. In doing so, we will highlight the operating characteristics of various adaptive sequential crossover designs evaluated using clinical trial simulations.


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