Simcyp PBPK Modeling and Simulation

Physiologically-based Pharmacokinetic (PBPK) Modeling: Getting Real Answers from Virtual Populations A recent FDA draft guidance for industry, “Physiologically-based pharmacokinetic analyses—format and content” highlights the regulatory currency that PBPK now garners: “Throughout a drug’s life cycle, PBPK model predictions can be used to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, […]

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