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was used for the comparison was 600 micrograms, and as you can see, the bioequivalence criteria, when they're applied to these data sets, the confidence intervals still fall well within the confidence bounds of 80 to 125.

These results also show the power and sensitivity of this method because it shows the sensitivity to detect real differences as evidenced by the values circled in red.  We've got a 14 percent increase in level 4, in product 4, for AUC, and on the same scale, we also have about a 9.5 percent decrease.  The confidence limits, if this were slightly more variable, would have clearly failed.

In conclusion, the FDA has thoroughly reviewed each of the NDA applications that have come in.  We've had a lot of data ‑‑ there were nine submissions ‑‑ the literature and the recent correction methods study, and we've concluded the following.  Levothyroxine can be evaluated in healthy subjects.  A single dose crossover study is a preferred method for detecting the true differences between products.  T4 is an appropriate and sensitive measure for this particular process, and a

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