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because if the blood levels are identical, it's very hard to think that therapeutic effects will be different.  In my experience, I have known no examples that belie this particular assumption for oral products, particularly.

If we don't believe this and we don't go by this assumption, we would have to do clinical studies for most drugs or at least we can make an argument for most drugs, and from my point of view, that would be sort of going against the concept of bioequivalence which is using a bioequivalence study as a surrogate for a clinical study for approval of generic drugs.

I'm going to go through some of the studies that I've seen and give you an idea of the results.

The first study was a dose proportionality study.  First of all, the dose formulations are dose proportional.  They're the same formulation, just larger tablets as the dose goes up.  The pharmacokinetics show very good dose proportionality, and I think in the next slide, you're going to see the results of the dose proportionality study.

These are three different doses just made up to 600 micrograms, and I think it was 50, 100 and 300, and

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