Uniformity, Current Approaches, Statistical Analyses and Presentation of an Alternative Approach, with Special Reference to Oral Inhalation and Nasal Drug Products, again with special reference to the OINDP. This paper proposed an approach that clearly states the allowable level of consumer risk and of what constitutes an acceptable batch. It didn't state what constitutes the acceptable batch, but it proposed an approach that allows for specification of an acceptable batch.
Then, lastly, on November 15th of 2001, IPAC-RS presented to the agency a lengthy report called A Permit to Tolerance Interval Test for Improved Control of Delivered Dose Uniformity of Orally Inhaled and Nasal Drug Products, and that also is based upon hypothesis testing, and it includes, in addition to the tolerance interval, two side conditions. One is a limit on the standard deviation and another is a limit on the mean, and Dr. Olsson will discuss that in more detail.
Now, I've now got a series of four slides outlining OPS issues that has been discussed in earlier meetings between the agency and IPAC-RS, but before I present these four issues, some of which may in fact have