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Activity Number: 245
Type: Contributed
Date/Time: Monday, August 4, 2014 : 2:00 PM to 2:45 PM
Sponsor: Biopharmaceutical Section
Abstract #314078
Title: Retrospective Look at Adaptive Design by Applying Potvin's Method
Author(s): Juhui Jiao*+ and Sudhakar Rao
Companies: Janssen and Janssen
Keywords: Adaptive design ; Bioequivalence ; Clinical trial ; Clinical pharmacology ; Group sequential ; Interim data
Abstract:

Adaptive design (AD) has received a lot of attention in the statistical, pharmaceutical, and regulatory fields recently [1].

In clinical pharmacology studies, contingent on the required sample size for BE studies and the lack of knowledge regarding the new formulation, group sequential and/or adaptive design will be an option to consider. Several publications can be found citing the implementation of group sequential or adaptive design in BE studies. Potvin D. et. al (2008) [2] has proposed a 2-stage design for bioequivalence studies. Comparisons between adaptive design and traditional BE is mostly done based on simulation.

The current presentation is focused on comparisons of BE studies between 2-stage AD by applying Potvin's method and traditional design based a real life example of a study.

References

1. FDA, Guidance for Industry: Drug Interaction Studies - Study Design, data Analysis, Implications for Dosing, and Labeling Recommendations (Draft), February 2012.

2. Potvin D. et. al. Sequential Design Approaches for Bioequivalence Studies with Crossover Designs. Pharmaceutical Statistics, vol 7, pp 245-262, 2008.


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