Division II.6.1.4

Data on the pharmacodynamic effects of a substance shall:

1. (a)

   enable to identify/characterise the mode/mechanism of action of the substance;

2. (b)

   enable characterisation of the dose-response relationship for relevant pharmacological endpoints;

3. (c)

   provide insight into the potential toxic effects of the substance based on knowledge of known effects of other substances with similar pharmacodynamic properties;

4. (d)

   aid the understanding of the mechanisms underlying adverse effects seen in toxicology studies;

5. (e)

   provide, in certain cases, information on the relevance of effects seen in laboratory animals for humans.