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FOOD AND DRUG ADMINISTRATION - page 241 / 263

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subclinical hyperthyroidism, and osteoporosis.  It may not create a big problem over the course of a 6-week bioequivalence study, but long term for our patients, it does.  We know there are data on how many times we physicians have to change the dose by 12.5 micrograms to make our patients feel better and be less symptomatic.  There are data that can be provided for that.

So we're talking about a TSH test that may not be perfect but it's the best thing we have now, and what we're asking the committee to do, what I'm asking the committee to do is to consider getting the experts together, analyze all these pros and cons and come up with what would be the best method of assessing bioequivalence because we don't have it.

In reference to Dr. Johnson's comments, the choice in the Abbott study to me of 600 versus 400 versus 450, that wasn't the design of the study.  That study, as far as I can tell, was designed to assess whether we could detect differences between 10 and 30 percent, not whether we should assess bioequivalence using 400 or 450.  That was not the intent.

It may not be that TSH may not be best, but

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