Which Tmax to be consider in case of b.i.d. dosing? [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2016-04-13 13:49  – Posting: # 16199
Views: 3,279

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 (pAUC0–τ, Cmax,0–τ, tmax,0–τ and pAUCτ–t, Cmax,τ–t, tmax,τ–t) as well as the global ones (AUC0–t, Cmax, tmax).

Cheers,
Helmut Schütz
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