BRIEFING

 〈1099〉 Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples. This proposal is based on the version of the chapter official as of March 1, 2019. On the basis of comments received, the proposal published in PF 47(4) [Jul. –Sep. 2021] has been canceled and is being replaced with this new proposal. It seeks to clarify that 〈1099〉 is not linked to Uniformity of Dosage Units 〈905〉. It also includes new Table 2 and moves the statistical formulas to an Appendix.

 (GCSTAT: R. Dasari)

 Case ID—SUB-1689