BRIEFING

 〈121〉 Insulin Assays. This proposal is based on the version of the chapter official as of December 1, 2020. Based on comments received, the proposal previously published in PF 50(6) has been canceled and is being replaced with this new proposal. This new proposal incorporates modifications made in response to public comments received during the review period. A new in vitro cell-based bioidentity test for insulin human and insulin aspart is added as an alternative approach to the in vivo bioidentity test using rabbits. This addition provides manufacturers with two validated options for demonstrating insulin human or insulin aspart bioidentity: the existing In Vivo Bioidentity Test and a newly proposed In Vitro Cell-Based Bioidentity Test for Insulin Human and Insulin Aspart.

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

 (BIO2: J. Sun)

 Case ID—SUB-2784