Utilization of PBBM/PBPK Models for Building a Safe Space and Regulatory Applications in Support of Drug Product Quality

Software: GastroPlus®
Division: Simulations Plus

Sandra Suarez-Sharp, VP of Regulatory Affairs presents to the GastroPlus User Group – the concept of safe space to decrease the regulatory burden and enable flexibility in regulatory assessment. The idea of safe space has gained popularity among the scientific community, including regulatory agencies, as a more inclusive tool that does not precisely require building an in vitro-in vivo correlation (IVIVC) to support significant CMC changes.

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