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The EMA has issued a concept paper for a Scientific guideline (Ref. EMA/CHMP/644998/2016):
Concept paper on an addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009).
If you wish to make comments please contact me [email protected] by4th October.
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