Module 18 - Drug Device Combinations and Other Technologies

05/12/2023

Assess Available Information

 Weight of Evidence Approach

● Physicochemical properties: is it likely to penetrate skin? ● Are there any epidemiological data? ● Is it a pharmaceutical ingredient, cosmetic ingredient or food additive? ● Do closely similar substances exist for which there are data? – “Read-Across”

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Read Across ( After Scialli, 2008 )

Property

Substance A R

Substance B R

Substance C R

Substance D R

1

36

48

?

72

2

180

240

300

360

3

1.2

?

2.0

2.4

4

5.0

7.5

12.5

22.5

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15