Bioequivalence and Bioavailability Forum

Dear Joy,

nice to have you back!

❝ For comparative dissolution profile and consequently, bioequivalence testing, can 2 tablets of the test drug be compared with 1 tablet of the reference drugs? The label claim of the test drug is 5 mg/tablet while the reference drug available locally has a strength of 10 mg. May I solicit your thoughts on this.

Dissolution testing should be performed with one unit. Having two tablets in the vessel will change hydrodynamics. Why don’t you compare 1 unit of 5 mg with 1 unit of 10 mg in vitro? On the y-axis you have %dissolved – not absolute values anyhow.
I once have seen an accepted (!) biowaiver where 2 units vs. 1 units were tested – but this was a mistake both by the applicant and the assessor.

In the biostudy: 2×5 mg (test) vs. 1×10 mg (reference).