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

posted by maulik963 – India, 2016-04-16 12:32  – Posting: # 16209
Views: 2,953

Dear Helmut,

» 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).

Thanks for your valuable information. I understood that all PK-metrics of both dosing interval should be provided but if i wish to conclude the result, Which Cmax i should consider?

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