Bioequivalence and Bioavailability Forum

Dear Divyen!

thank you so much for prompt reply
please see my additional questions

❝ For Point 1: I guess, it depends on variability.

As for other studies, just CV is not enough. What are the regulatory limits then and for what metric? That phrase in MR GL seems like just exploratory analysis with descriptive statistic, since there are no predictions and no checking against set of MR formulations as we do in IVIVC

❝ For Point 2: Kindly see page 37/46- Role and Choice of Reference Formulation for Deconvolution. Immediate release formulations can be used as RFDs in IVIVC studies and will also allow adequate approximation of the in vivo drug release from the MR formulations as long as the rate of dissolution from the IR formulation is fast relative to its absorption (which is normally the case for the drugs that are chosen as suitable for MR product development).

Does it mean that exponential terms should be derived from individual models of subjects after dosing by IR product?