Bioequivalence and Bioavailability Forum

Hi Alex!

First one assumption: You know from somewhere else (literature data: preferably IV or IR oral) that what you see after SC is the true elimination (no flip flop PK). If this is the case it might be possible that the drug precipitates to a minor extent at the injection site. A major fraction of the dose is released from the depot (zero order), but the precipitated fraction starts to dissolve after a lag-time. Then a first order would be possible.

❝ Do you know some literature/references where such a pharmacokinetic model is mentioned/described?

No.

❝ Is it straight-forward to apply NCA or should i try to fit a "fancy" model?

Both should work; it depends on what you want to achieve.