85 percent of the batch falling within 75-125 percent of label claim, a number that they obtained by evaluating what the FDA proposal actually was doing.
Now, what that looks like is the following. So this is again, as Dr. Olsson had alluded to, based on normal distribution, and it's intended to show you the combinations of means and standard deviations in the batch that correspond to that limiting quality specification. Remember, that's 85 percent of the batch falling within 75 and 125 percent.
So the idea is that anything that's inside that red line should be acceptable because anything inside the red line satisfies the standard of at least 85 percent of the batch falling within 75 to 125 percent of label claim.
Then that gets us into some of the language that you've been hearing already this morning and I'll elaborate a little bit. The term sometimes is called consumer risk. We can call it a false positive. Also the statistical language would be the type I, or alpha error, and that here in this context means that a batch that lies outside the specifications; that is, any batch that lies