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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Amarin Technologies — pharmaceutical CDMO with transdermal out-licensing strategy from Argentina to global markets

Pharmaceutical CDMO Out-Licensing Strategy: How Amarin Technologies Built Global Reach from Argentina

Amarin Technologies operates as a pharmaceutical CDMO with an out-licensing strategy in one of the more challenging operating environments in the world, Argentina. For potential partners evaluating a CDMO for transdermal development, licensing, or commercial supply agreements, the Argentine context is either a concern or, on closer examination, evidence of [...]

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