Bioequivalence and Bioavailability Forum

I am looking for a reference to on what basis we are doing partially and fully replicate studies for high variable drugs (i.e. CV more than 30 %).

My doubt is suppose the drug having the CV is 45%, then how can we decide whether we need to go 3 way or 4 way

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Edit: Category changed; see also this post #1. [Helmut]