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FDA urges QbD approach for transdermal patches

This article was originally published in The Gold Sheet

Executive Summary

FDA asked manufacturers in an Aug. 3 draft guidance document to use quality-by-design approaches to minimize the amount of residual drug left in transdermal patches. The guidance notes that currently marketed transdermal patches may retain 10 to 95 percent of the initial total amount of the drug after the intended use, raising a potential safety issue for patients and their family members

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