least common multiple of T and R [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2021-05-24 12:32 (27 d 19:36 ago) – Posting: # 22364
Views: 477

Hi Vishal,

» How to prove the bioequivalence if test formulation having strength 325 mg and reference formulation having strength 500 mg

When administering single doses, such a large dose-correction will not be acceptable (see there). I did it once 20 years ago when strict dose-proportionality was known for R and proven for T in another study. It was accepted by the German BfArM but we were told at the same time “Please do that never again.”

You would need to administer the least common multiple of the strengths (6,500 mg), i.e., 20 units of T and 13 units of R. This will be difficult even if this single dose is within the approved range.

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