Bioequivalence and Bioavailability Forum

Hi everyone,

Just a random thought about another advantage of a 4-period full replicate (TTRR) study over a 3-period partial replicate (TRR) study design besides 1) reducing the sample size and 2) elucidating the ISCV of the test.

If a previous partial replicate study (TRR) showed that 1) Ref ISCV was significantly > 30% (lets say 50-60%) 2) the (Ref1/Ref2) ratios for PK were significant (ie: 15% or higher), wouldn't a 4-period full rep (TTRR) study be the preferred choice if one assumes that the test could show the same behavior as the reference (meaing T1/T2 ratio > 15%)? In such scenario you are more or less stabilizing both the test and reference by giving each 2x.

I am just wondering if this would help in terms of meeting the 80-125% ratio requirement.

I apologize for the crazy writing but I was doing something else while this stupid idea popped up...

Thanks
John

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Edit: Category changed. [Helmut]