Enabling Clinical Assessment of Maralixibat for Rare Pediatric Liver Disease via Real Time Adaptive GMP Manufacturing

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Enabling Clinical Assessment of Maralixibat for Rare Pediatric Liver Disease via Real Time Adaptive GMP Manufacturing - AAPS 2017

A flexible, real-time adaptive GMP manufacturing model is required to support the increasing requirement for clinical trial conduct in small patient populations with challenging trial designs and treatment algorithms.

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