Deconvolution sample size and design issues [Power / Sample Size]

posted by dshah  – India/United Kingdom, 2023-02-09 17:20 (234 d 15:24 ago) – Posting: # 23451
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Dear Mittyri!

Kindly see Appendix III. It is typo error.
For Point 1: I guess, it depends on variability. Kindly see point 2 and 3 of yours.
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).
Point 3: I guess 2 period only. Considering you are focusing on- Application for a modified release formulation of a drug that is authorised in a formulation with a different release rate, so IR and MR.
Point 4: Not aware about EPARs.

Apologies, but was struggling with reply point wise- so had written like this.

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