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SUPAC-transdermals draft requires prior-approval supplement for rate-control layer change.

This article was originally published in The Tan Sheet

Executive Summary

SUPAC-TRANSDERMALS DRAFT REQUIRES SUPPLEMENTAL REPORT for rate-control layer change, a material change in the layer's specifications, regardless of vendor. The change will require an in vitro/in vivo correlation or bioequivalence study, stability data and the attainment of functional requirements to be in accordance with the draft materials for the Scale-Up and Post-Approval Changes Guidance for Transdermal Drug Delivery Systems.
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