Bioequivalence and Bioavailability Forum

Hi Maulik,

❝ ❝ Why did you decide to take 12h interval, not 13h and 11h?

❝

❝ Reply: The dosage regimen for Immediate release formulation is twice daily thats why second dosing done at 12.0 hours interval.

That’s not a justification!

❝ ❝ ❝ As Reference product is to be given two times a day at 12.00 hours interval …

BID does not necessarily mean τ 12 h. What does the label/SmPC of the IR product state? For a lot of “uncomplicated drugs” BID may as well allow for a “convenient” dose regimen (e.g., 7 a.m. and 10 p.m. = τ 15/9 h). For some drugs (antibiotics, anticonvulsants, …) a strictly equal dosing regimen is mandatory. Yet others (diurnal variation in PK) may mandate a fixed dose regimen with unequal intervals in order to minimize fluctuations. Hence, BE-proff’s question makes sense indeed.

Essentially it boils down to the target you had in mind developing the MR formulation. I would explore all PK-metrics in both intervals (pAUC_0–τ, C_max,0–τ, t_max,0–τ and pAUC_τ–t, C_max,τ–t, t_max,τ–t) as well as the global ones (AUC_0–t, C_max, t_max).