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Clinical Studies for Generic Transdermal Patches: Bioequivalence, Adhesion, and Skin Safety Requirements

The clinical requirements for generic transdermal patch approval are substantially more demanding than those for conventional oral dosage forms. A generic tablet typically needs to demonstrate pharmacokinetic bioequivalence in a single crossover study. A generic patch requires bioequivalence under single and multiple dose schemes, statistical non-inferiority in adhesion performance, and [...]

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