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Practical sheet | REF: FIC1457 V2

Determining DMEL

Author: Alain LOMBARD

Publication date: November 10, 2025 | Lire en français

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    3. How can a DMEL be derived in practice?

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

    3.1 How can a dose obtained by one route be derived for another route?

    First, it must be ensured that the substance has similar ADME properties in the tested animal and in humans. In the absence of information, ADME will be considered similar for 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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