Bioequivalence and Bioavailability Forum

Hi Maulik,

❝ As I understood, C_max(x) denotes for an Immediate release phase of the formulation and C_max(x+1) denotes for the modified release phase of the formulation.

In your case (biphasic), yes. The guideline deals with multiphasic formulations. Hhence, x>2 is possible.

❝ In addition to C_max(0-2) & C_max(2-t), shall I consider C_max(total) [i.e. C_max(0-t)] to demonstrate BE?

No. In my studies I only reported it.

❝ Based on the above discussion shall I keep below PK parameters to demonstrate BE?

❝ AUC_0-t, AUC_0-∞, _partialAUC_(0-2), _partialAUC_(2-t), C_max(0-2), C_max(2-t) & C_max(0-t).

Exactly. Good luck for demonstrating BE of seven PK-metrics…

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PS: If you crosspost (e.g., to David’s PKPD-list) link to this thread as well. Helps others “over there” to see what’s going on.