Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

This guidance provides recommendations for the design and conduct of studies to evaluate the in 17 vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery 18 system (collectively referred to as TDS2).

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,Drug Administration ,Guidance Issuing Office ,Submit Comments ,Drug Evaluation ,Sensitization Potential ,Topical Delivery Systems ,