Approach to establish a pharmacological acceptable daily intake (ADI) - Scientific guideline

This document gives advice on when to establish a pharmacological ADI and provides guidance on the pharmacological studies and endpoints to be addressed.

Keywords: Acceptable daily intake (ADI), consumer safety, pharmacological ADI, pharmacological endpoints

Current effective version

Guideline on the approach to establish a pharmacological acceptable daily intake

Adopted Consultation dates: 10/01/2012 to 31/07/2012 Reference Number: EMA/CVMP/SWP/355689/2006 Summary:

This guideline gives advice on when to establish a pharmacological acceptable daily intake and provides guidance on the pharmacological studies and endpoints to be addressed.

Document history

Overview of comments received on the guideline on the approach to establish a pharmacological acceptable daily intake

Reference Number: EMA/CVMP/SWP/634672/2012

Concept paper on a guideline on the assessment of pharmacological/pharmacodynamic data to establish a pharmacological ADI draft

Reference Number: EMEA/CVMP/SWP/122154/2005