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FOOD AND DRUG ADMINISTRATION - page 199 / 263

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opposite approach.  It says that that large dose totally and completely shuts down the production of endogenous T4.

What are the other approaches?  One, we know that biology isn't that constant like the horizontal correction method, that there's fluctuation through the day.  So what we did was use day minus 1 data and corrected based on that.

Then we had a rather novel approach.  Since we collected TSH in the study and since we found that TSH was suppressed, why not marry the good parts of the last two correction procedures and make the wash-out dependent on the suppression of TSH?  That's this method?  I showed two different curves.  Actually this allows every individual to be corrected.  So if there's very little suppression of TSH, then it comes very close to the day minus 1 method.

Then the last thing we did, as recommended in the open session, TSH is a factor that has to be looked at and we did in our study.

Now, in this graphic to the right, I'm going to show the results of our study.  Just to orient you, down at the bottom of the graph, what we're going to plot is the area under the curve ratio for a 450 microgram dose

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