Benefits of Model-based Drug Development: A Rigorous,Planned Case Study |
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| Authors: | Russell Reeve Seth Berry Wei Xiao Bradley Ferguson Marcel Thürk Rüdiger Goetz |
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| Institution: | 1. Quintiles, Inc., Morrisville, North Carolina, USARussell.reeve@quintiles.com;3. Quintiles, Inc., Morrisville, North Carolina, USA;4. North Carolina State University, Raleigh, North Carolina, USA;5. Qlaym, GmbH, Düsseldorf, Germany |
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| Abstract: | Model-based drug development (MBDD) is useful to make better quantitative decisions within drug development. However, rigorous evaluation of the benefits has been scarce in the literature. In this study, we take a completed development program, retrospectively repeat it in a virtual setting using MBDD methodologies, and compare it to the traditional drug development process. The conclusion is that the use of MBDD could have facilitated more efficient use of resources. |
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| Keywords: | Adaptive trial Bayesian Dose response Model-based drug development Phase I Phase II |
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