Skills: Acquired knowledge and the scientific and technical development of MT3D

The conception of methods and the set-up of the very first phase 0 studies in France.

This approach can help save development time in numerous situations:

• When the results obtained from microdosing show that it is necessary to go back to the “Structure Activity Relationship” (SAR) phase in order to re-work one of the pharmacokinetic aspects of the molecule.
• When there is a choice to be made between several molecules.

Microdosing is also an effective way of accurately determining the initial dose to be administered in phase I studies.

Integration of the e-CRF into phase I studies

Although this approach is not widely used because of the small number of subjects, it can be useful for :

• guaranteeing the security of source data
• limiting the number of demands for explanations
• following the study in real-time
• speeding up the monitoring process
• gaining at least 2 months on the usual report delivery time