Dear Sir/Ma'am
I have few questions on IVIVC, I would be grateful if you can answer these:
1) when should we keep Finf "fixed" or "estimated" ?
2) Can we keep Finf < 1 and if that is so, what is the rationale ?
3) I have found in an ivivc exercise that, %cumulative disso. release (at 0.25, 0.5, 1 & 2 hr) is lesser for a formulation compared to others, the Frel (fraction dissolved in vitro) for that formulation is however greater compared to ohers. The prediction of PK (Cmax & AUC values) came out to be greater also for that formulation compared to others. Does that mean % cumul release have no bearing on AUC or Cmax and it all depends on Frel for ivivc prediction ?
Thanks
Arindam