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For ANDA submissions, Population Bioequivalence (PBE) analysis is required on the SAC data to demonstrate that the generic products dose delivery is statistically equivalent to the reference listed drug (RLD)

doi: 10.1080/21688370.2017.1373208

Lp(a), meanwhile, has gained increasing attention because it is largely genetically determined, independently associated with ASCVD and calcific aortic valve disease, and poorly captured by a standard lipid panel (Koschinsky et al., 2024)

there was a 32% reduction in the number of patients inappropriately receiving B-12 (521 to 352) , and the proportion of patients receiving B-12 at the correct frequency rose from 58% to 72%