. Author manuscript; available in PMC: 2010 Dec 1.

Published in final edited form as: J Biomed Inform. 2009 Jun 16;42(6):990–1003. doi: 10.1016/j.jbi.2009.05.010

Table 6.

This table shows the set of labels, or ranking categories, that the drug experts used define LOEs.

Ranking category	Evidence types
in vitro categories
iv-met-enz-id-Cyp-450-with-inh	A CYP450, recombinant, drug metabolism identification experiment using chemical inhibitors A CYP450, human microsome, drug metabolism identifi- cation experiment using chemical inhibitors A CYP450, recombinant, drug metabolism identification experiment using antibody inhibitors A CYP450, human microsome, drug metabolism identifi- cation experiment using antibody inhibitors
iv-met-enz-id-Cyp-450-recombinant	A CYP450, recombinant, drug metabolism identification experiment with possibly NO probe enzyme inhibitor(s)
iv-met-enz-id-Cyp-450-microsomal	A CYP450, human microsome, drug metabolism identifi- cation experiment
iv-met-inh-recombinant	A CYP450, recombinant, metabolic enzyme inhibition ex- periment
iv-met-inh-microsomal	A CYP450, human microsome, metabolic enzyme inhibi- tion experiment
Clinical Trial categories
pk-ct-pk	A randomized DDI clinical trial A genotyped pharmacokinetic clinical trial A phenotyped pharmacokinetic clinical trial
pk-ct-pk-genotype	A genotyped pharmacokinetic clinical trial
pk-ct-pk-phenotype	A phenotyped pharmacokinetic clinical trial
pk-ddi-non-rndm	A non-randomized DDI clinical trial: A parallel groups DDI clinical trial
pk-ddi-rndm	A randomized DDI clinical trial
Statement categories
label-statement	A non-traceable drug-label statement
nt-statement	A non-traceable, but possibly authoritative, statement
Observation-based categories
obs-eval	A published and evaluated observation-based ADE report
“not applicable” categories
na-primary-total-clearance-enz ^†	A non-traceable, but possibly authoritative, statement
na-primary-metabolic-clearance-enzyme ^†	A CYP450, human microsome, drug metabolism identifi- cation experiment using chemical inhibitors
na-substrate-of ^†	A CYP450, recombinant, drug metabolism identification experiment with possibly NO probe enzyme inhibitor(s)

Note: multiple evidence types that the drug experts thought would confer roughly the same degree of justification for drug mechanism assertions are represented by a single label.

^†

A ranking category created to represent evidence types that the drug experts felt would not be applicable to supporting or refuting particular assertions.