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Interchangeability guidances for transdermal systems need harmonization, as the next challenge to add uniformity and scientifical sense to the regulatory process. There are key differences among current guidances for interchangeability of transdermal systems, which could mean that a same clinical study is approved in one region and rejected in another one. [...]
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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 [...]
Correct adhesion of a transdermal patch throughout its entire wear period is not an aesthetic property — it is a drug delivery important condition. A patch that partially lifts off from the skin delivers less drug than labeled, with unpredictable pharmacokinetic consequences [...] [...]