Table 4.
Calculated safety margin for the cholestatic risk of CyA in the three PHH donors.
| d7 | d14 | d21 | d28 | |||||
|---|---|---|---|---|---|---|---|---|
| CyA Conc. µM * | SMCHOL | CyA Conc. µM * | SMCHOL | CyA Conc. µM * | SMCHOL | CyA Conc. µM * | SMCHOL | |
| S1353T | 5 | 6.50 | 5 | 6.50 | 5 | 6.50 | 5 | 6.50 |
| S1391T | - | - | 5 | 6.50 | 0.5 | 0.65 | 0.05 | 0.06 |
| S1506T | 5 | 6.50 | 5 | 6.50 | 5 | 6.50 | 5 | 6.50 |
* is the lowest concentration producing a CIx below 0.80 at the respective time-point. The SMCHOL was calculated considering the Cmaxtotal of CyA. A SMCHOL under 30 was taken as an indicator as cholestatic risk [14]. CIx—cholestatic index; CyA—cyclosporine-A; d—day; SMCHOL—safety margin for drug-induced cholestasis.