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FOOD AND DRUG ADMINISTRATION - page 247 / 263

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critical factor here, and what we have here is certainly something that's pharmaceutically equivalent and bioavailable, but beyond the bloodstream, can we really assess the bioequivalence?  It just seems like it's going to be a horrendous task to try to do that.  That's a clinical marker.

DR. SADEE:  It would appear to me that endogenous substrates are so different from each other, that making the decision tree in which you force how you proceed might be very difficult.  I think it would have to come up with a decision tree and then we can test it against all the endogenous substrates that we might want to look at.  The example of thyroxine is one.  It's such an extreme example, although the elements are all there, the self-regulation and so on, but you may take it on a case-by-case basis, but if you do produce a good decision tree that people can be actually guided by, then it would be very helpful.  We need to see the details.

DR. HUSSAIN:  So from that sort of comment, should I perceive that we may not take this up as the first topic in the Biopharmaceutics Committee and move to something else then?

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