Module 18 2021

08/02/2021

Outcome

• Incorporate drug into implantable device  • Slow release, sustained plasma levels at therapeutic  level with less variability • One treatment every three months  • Potentially more favourable patient outcomes

The Organisation for Professionals in Regulatory Affairs

17

What are the safety considerations?

• Target organ toxicity • Local toxicity • Degradant/impurity profile

The Organisation for Professionals in Regulatory Affairs

18

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