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FOOD AND DRUG ADMINISTRATION - page 162 / 263

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something that was very interesting.  If you look, you see that when we shifted them over, there are some patients that jumped way up in TSH values, that when we shifted over to the reference product, TSH levels in some patients went up quite considerably, and went up in fact above the range in which most clinicians would have begun to question that particular product or that particular result to the point where they may have switched them and actually had to do dose adjustment because the TSH levels at that point were above the 4 to 5 to 6 that most clinicians consider to be relevant whenever they're making dose adjustments.

Now, I thought this was very interesting whenever we looked at this.  I wanted to see if there were any other products that were done similar that were tested in a similar way and found another study.

May I have the next slide, please?  This was a study that I found in actually the Virginia Formulary through FOI and it was done by Forest Laboratories.  This again was a product in which both products were given to patients and it was done at steady state in which they also measured TSH levels.  I apologize for the quality of

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