Approach to establish a pharmacological acceptable daily intake (ADI) - Scientific guideline
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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
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Overview of comments received on the guideline on the approach to establish a pharmacological acceptable daily intake (PDF/63.15 KB)
First published: 19/11/2012
Last updated: 19/11/2012
EMA/CVMP/SWP/634672/2012 -
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Concept paper on a guideline on the assessment of pharmacological/pharmacodynamic data to establish a pharmacological ADI draft (PDF/39.24 KB)
First published: 18/05/2005
Last updated: 18/05/2005
EMEA/CVMP/SWP/122154/2005