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FOOD AND DRUG ADMINISTRATION - page 243 / 263

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DR. KIBBE:  Gary, do you have anything?

DR. HOLLENBECK:  Well, I'm not sure now is the best time to ask it, but I am somewhat intrigued by the question that was asked about doing these studies in patients with no thyroid function.

Could someone from FDA just sort of respond and answer that question?  Is that an unrealistic thing to do?

DR. JOHNSON:  Yes.  Actually, we've talked about that quite a bit within the Clinical Division and we felt that that was an unrealistic study type, just to do it in athyrotic patients.  We need to do, first of all, the recruitment process, and second of all, if we're taking into consideration TSH, the number of subjects would be astronomical.  So the decision was made actually prior to 1997 when this first guidance was put together.

DR. HOLLENBECK:  I wasn't referring to TSH.  I was just referring to testing a traditional bioequivalence test using patients with no thyroid function.  So is the first part of your answer the really relevant one here, that there aren't enough subjects to do that?

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