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〈111〉 Design and Analysis of Biological Assays

BRIEFING

〈111〉 Design and Analysis of Biological Assays. This proposal is based on the version of the chapter official as of August 1, 2020. In developing Analysis of Biological Assays 〈1034〉, the Bioassay Subcommittee decided that one of the three options for combining results from independent assays included in 〈111〉 should be dropped from 〈1034〉. The removed option was the one involving a preliminary chi-square test. The purpose of this revision is to align 〈111〉 with 〈1034〉 by removing that one option. The other two options and the other sections of this chapter have not been revised.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCSTAT: R. Dasari)

 Case ID—SUB-1608

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