Module 18 2021

08/02/2021

Situation: Once daily oral drug

• Limited therapeutic period • Variable bioavailability • Marked food effect • Risk of toxicity/side effects (liver toxicity) • Patient compliance

Design a system that delivers a safe and effective dose for a sustained period

The Organisation for Professionals in Regulatory Affairs

13

Design a system that delivers a safe and effective dose for a sustained period

• Incorporate drug into implantable device • Slow release, sustained plasma levels at therapeutic concentration • One treatment every three months

The Organisation for Professionals in Regulatory Affairs

14

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