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"Individual" bioequivalence studies not justified for all generics, Perrigo maintains.

This article was originally published in The Tan Sheet

Executive Summary

"INDIVIDUAL" BIOEQUIVALENCE STUDIES NOT JUSTIFIED FOR ALL GENERICS, PERRIGO maintains in March 2 comments submitted in response to FDA's recent draft guidance, "In Vivo Bioequivalence Studies based on Population and Individual Approaches." Perrigo "strongly disagrees with the case of individual bioequivalence results for all generic studies," the comments state. The company suggests "wholesale" use of the individual approach would increase the cost of studies "with no corresponding improvement to healthcare [of] the American public."
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