Bioequivalence and Bioavailability Forum • Which Tmax to be consider in case of b.i.d. dosing?

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

posted by maulik963 – India, 2016-04-16 14:32 (3349 d 19:18 ago) – Posting: # 16209
Views: 5,539

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 (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).

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?

Complete thread:

Which Tmax to be consider in case of b.i.d. dosing? maulik963 2016-04-13 08:06
- Which Tmax to be consider in case of b.i.d. dosing? BE-proff 2016-04-13 09:27
  - Which Tmax to be consider in case of b.i.d. dosing? maulik963 2016-04-13 13:09
    - Which Tmax to be consider in case of b.i.d. dosing? Helmut 2016-04-13 13:49
      - Which Tmax to be consider in case of b.i.d. dosing?maulik963 2016-04-16 12:32