Module 18 - Drug Device Combinations and Other Technologies

05/12/2023

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

15

Biological Evaluation

Drug Plasma levels

70.00

60.00

50.00

40.00

30.00

20.00

10.00

0.00

28

33

38

43

48

53

58

63

Time (Days on Study)

The Organisation for Professionals in Regulatory Affairs

16

8