aware that Dr. Olsson will be speaking to this issue of the non-normally distributed data.
Properties of the test when the batch is at or below the IPAC-proposed limiting quality of 85 percent coverage.
Another issue is the impact of eliminating the zero tolerance criterion. IPAC-RS claims that this criterion increases the producer risk with little improvement in consumer protection, but it may have some value for skewed data; that is, the distribution which is non-normally distributed and some data which are way out. So it may have some value in protecting against skewed data.
And lastly, the issue of the alpha level being less than or equal to .05 percent. We did some analyses of this approach in house. Don Schuirmann did this work and found that under certain circumstances, in fact, the alpha level goes considerably higher than 5 percent, and subsequently, IPAC-RS addressed this issue and has now reduced that alpha level closer to 5 percent, perhaps slightly above, but it all depends upon the particular non-normal distribution and the distance between the label