Module 18 - Drug Device Combinations and Other Technologies

05/12/2023

Medicated TDS: What are the safety considerations?

• Degradant/impurity profile – Evaluation of leachables/extractables

• Not phototoxic • Not genotoxic • Not irritant • Not sensitizing

The Organisation for Professionals in Regulatory Affairs

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Biological Evaluation

 Assess all available information  Assess required toxicological information  Identify gaps

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