Module 18 2021

08/02/2021

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

15

Challenges

• Drug stability in device • Drug/device interactions • Local toxicity • Systemic toxicity

The Organisation for Professionals in Regulatory Affairs

16

8