considered in any way related to dose uniformity?
DR. HAUCK: Well, I think I should turn that one over to Wally.
DR. ADAMS: Yes. That's a good question. We're talking here about dose content uniformity testing, and we are not talking about delivery of the drug to the pulmonary tract or to the nasal passages.
This test is based upon the drug ex actuator; that is, after it's fired, it's the dose of active drug that is emitted from the actuator, independent of particle size distribution and independent of delivery to the lungs.
Does that answer the question?
DR. KORCZYNSKI: Yes.
DR. KIBBE: When you eliminate the zero tolerance and you do a statistical analysis, at what point would the batch fail? For instance, if one sample out of a group of samples that were taken, one item had absolutely no material in it, statistically, that might still allow the numbers to come out such that the batch could pass, but I would wonder whether there would be some remedies taken within the company to find out why it was completely empty. At what point do you start to make, I