New How is the fm, in vivo calculated in DIDB?

Fm, in vivo values, as presented in the PK profiles, are calculated based on the highest change in AUC observed with a strong inhibitor in DDI studies, or as reported in NDA or BLA reviews. These values may sometimes be overestimated due to the possible involvement of other enzymes or transporter pathways that are also inhibited by the precipitant. In such cases, the risk of overestimation is explicitly noted. Discrepancies in fm values may arise due to the selection of a single DDI study (worst case scenario) or the involvement of additional enzymes/transporters.