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Abstract:
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This presentation reflects the views of the authors and should not be construed to represent FDA's views or policies. A consideration in evaluating transdermal drug products (TDS) is the potential for irritation. In particular, applications for generic TDS must demonstrate that the test product is no more irritating than the reference listed drug (RLD). Currently, to establish the non-inferiority of the test product compared to the RLD with regard to the cumulative irritation scores, the upper bound of the one-sided 95% confidence interval of the mean test product score minus 1.25 times the mean RLD score must be less than or equal to 0. In this presentation, we will explore new methods and compare the performances of these methods along with the current method.
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