How to derive a DMEL practically?
Determining DMELs
Archive REF: FIC1457 V1
How to derive a DMEL practically?
Determining DMELs

Author : Alain LOMBARD

Publication date: February 10, 2015 | Lire en français

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3. How to derive a DMEL practically?

This procedure is similar to that used for DNELs ( cf. Determination of DNELs [FIC 1182] ).

3.1 How do you derive a dose obtained by one route from another?

The first step is to ensure that the ADME substance is similar in the animal tested and in humans. In the absence of such information, we will consider that the ADME is similar in humans.

If we only have a NOAEL from an oral study in animals, which is the most common experimental route, and we...

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