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AAPS 2019 Poster - Rapid Transition of a Novel Celecoxib Formulation from a Fit-for-Phase Presentation to a Commercializable Product Using an Innovative Integrated Drug Development and Clinical Testing Platform
Presented at AAPS 2019: An integrated CMC and clinical development program successfully identified a commercializable formulation of DRGT-46 meeting required taste and PK attributes as per the Target Product Profile. Real time, adaptive GMP ensured formulation development decisions were taken based on human clinical data. Program efficiencies included minimization of drug substance consumption, lean regulatory CMC data packages and a reduction in overall upfront CMC investments. The accelerated initiation of a Phase 1 study using an SDD PiB, and rapid transition to commercializable sachet formulation to support Phase III studies was achieved in less than 18 months.