How to establish a DMEL?
Determining DMEL
Practical sheet REF: FIC1457 V2
How to establish a DMEL?
Determining DMEL

Author : Alain LOMBARD

Publication date: November 10, 2025 | Lire en français

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2. How to establish a DMEL?

The steps are the same as for DNELs, except for the values of the no-threshold effects (see Determination of DNELs [FIC 1182] ).

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First, the toxicological profile of the substance must be established and all relevant data collected, then the most relevant and valid studies must be selected (Klimisch, see Criteria for determining the rating of a study (Tool

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