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FOOD AND DRUG ADMINISTRATION - page 202 / 263

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need these regulatory goal posts of 80 to 125 when we're thinking about consumer risk?

Next, the TSH correction method.  It gets four checkmarks.  It finds the two doses to be different from each other, but it has some disagreeable characteristics.  Number one, it's more sensitive.  Actually the point estimate is above the true value, and also the other issue that was talked about by Dale is the confidence interval is relatively broad.  So if you were to use TSH alone, then you would have to seriously consider broadening the confidence interval.

Now, back to the issue of horizontal correction, a picture was drawn with a perfectly flat line with horizontal correction.  Well, in reality, these are data from day minus 1 in our study for the three periods and the curves are not perfectly flat, and in fact, at 18 hours, there's a significant decline in levels.  So when you use the perfectly flat horizontal correction method, you're making an error due to that data point.

Another thing that we noticed in this study that is a testimony to the complexity of the biology of T4 kinetics is that with successive periods, this is period 1

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