Labelling of Investigational Drugs

Drugs intended for use in clinical trials should bear a label containing the following 

Drugs shipped for non-clinical trials should be labelled with one of the following 

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Reductive [ CJmethylation procedures have found broad application in the rapid labeling of investigational drug substances for in vitro studies where metabolism does not occur, in early exploratory in vivo investigations in drug research and development, and in peptide and protein mapping. However, because A -dealkylation reactions are common metabolic events, compounds labeled by Af-[ C]methylation are usually not suitable for registration studies. 

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