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manufacturing process factors affect product quality and performance, and two, the capability of process control strategies to prevent or mitigate risk of producing a poor quality product.

So this is where we want to be in the future and what we have to do today and how do we get there, I think we will be seeking your input on that in that journey.

Yesterday we discussed many topics which I think you can now link this to the future state.  For example, yesterday we discussed our system for ensuring therapeutic equivalence of generic drugs and also innovator drugs in the event of postapproval changes.  One topic that we discussed yesterday was topical products nomenclature that dealt with pharmaceutical equivalence, bioequivalence, and therapeutic equivalence, for example.

I also pointed out yesterday that if we do not look at that from a systems perspective, there is a humongous potential for misunderstanding, and if you just focus on bioequivalence, bioequivalence is never equal to therapeutic equivalence.  That's not the mantra we have.  That's not our system.  Our system starts with an entire

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