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FOOD AND DRUG ADMINISTRATION - page 155 / 263

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all know that and in recent years have come upon recommending a guidance so that we can overcome some of this variability and put some regulation on the production and design of thyroid products.

So, the recommended protocol now for a bioequivalence study is the standard study, but I'd like to point out a couple of things here.

Number one is the sample size, 24.  When you do a 24-subject bioequivalence study, you're suggesting that you have a relatively low level of variability, which we'll see in the data is true.

The other thing I'd like to point out is the dose, a 600-microgram dose.  That's a large dose, but because of analytical problems, it's very difficult to do these studies with smaller doses, and we'll talk about that as we go along.  So, what we do here is give multiple tablets of lower doses to equal the 600 micrograms.

The other thing that is a little different about this is the baseline correction.  That's been brought up before.  Now, they're asking not only for the total T4 but they're asking for baseline subtracted data and then performing a statistical analysis using

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