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So I think the TSH test is useful clinically, but it may not be the proper test for establishing bioequivalence.  Do you have some comments to that?

DR. KIBBE:  Anybody?

DR. CONNER:  I pretty much agree with you.  I'll defer to Steve's specifics about levothyroxine, but I think anything with a steep dose-response curve ‑‑ if you looked at the depiction of the confidence interval on TSH, number one, the point was made that the point estimate was way off of what it should be.  So number one, you weren't even getting the right answer from the center part or the mean.

But also if you look at the breadth of that confidence interval which is a reflection of variability, I would tend to guess that if you did that study on two lots of any manufacturer's product, it would probably fail, if that study was done, with that level of variability.

In fact, I would even go out on a limb and say that you might fail testing if you took the same lot and just randomly divided it into two sections and studied it

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