Another example of a best practices case study shared by FDA, the impact of the PBPK model for eliglustat was huge because a number of clinical studies that would have to be performed to assess/inform all of the drug-drug interaction (DDI) scenarios were eliminated. The DDI is dependent on both the dose and CYP2D6 phenotype: the CYP2D6 impact changes with the dose, therefore affecting DDI liability.

PBPK simulations informed the labeling for 12 DDIs and dosing recommendations. Labeling recommendations were incorporated based on modeling without the need for additional trials.

Gaucher disease is an inherited disorder that affects many of the body’s organs and tissues. According to the National Gaucher Foundation, the incidence of Gaucher disease is about one in 20,000.

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