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Consumer OTC Drugs

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

This article was originally published in The Tan Sheet

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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