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FOOD AND DRUG ADMINISTRATION - page 101 / 263

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inhalation, then there might be a second dose taken by the patient.  That might lead to an overdose.  If it's too much, it might lead to an overdose.  So I think what one should factor in is a statistical analysis of the risk of adverse effects and that should determine where there is a limit.

DR. ADAMS:  May I comment on that?  Just one thought is that with regard to the variability in the products, and you've mentioned about multiple dosing, patient taking multiple doses, you know, one consideration might be, while we are talking here in the context of a single standard across different dosage forms, MDIs, DPIs, nasal sprays, and across all drug classes, that different standards conceivably could be appropriate for, let's say, an inhaled corticosteroid than for a beta agonist where, with the beta agonist being used as rescue medication is important that that drug product on a given dose to deliver the expected dose.  Possibly on a chronically administered product, maybe greater variability could be allowed, but at this point, we have not made such considerations.

DR. HUSSAIN:  I think the question is the

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