Module 18 2021

08/02/2021

Medicated TDS: What are the safety considerations?

• Target organ toxicity - No • Local toxicity - No

• Degradant/impurity profile – Different profile of leachables/extractables (related to patch adhesive)

The Organisation for Professionals in Regulatory Affairs

25

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

26

13