Module 18 2021

08/02/2021

What are the safety considerations?

• Target organ toxicity – No Liver effects • Local toxicity – Some inflammation • Degradant/impurity profile – None new

The Organisation for Professionals in Regulatory Affairs

19

Pharmacological Response

6

5

4

3

2

1

0

Day 10

Day 30

Day 60

Day 90

10 mg/kg 30 mg/kg 100 mg/kg

The Organisation for Professionals in Regulatory Affairs

20

10