TABLE 1.
Inclusion and exclusion criteria for clinical drug safety drug–drug interaction (DDI) abstract selection.
Inclusion | Clinical trial DDI toxicity study: Phase I/II/III clinical trials in which drug combination and/or single drug toxicity data are evaluated and reported |
Pharmaco-epidemiological DDI study: Pharmaco-epidemiology studies in which toxicities from drug combinations are reported and compared to toxicities from a single drug | |
DDI and adverse drug event (ADE) case reports: DDI-induced ADE cases in which the time sequential drug and ADE are reported in clinical settings | |
Exclusion | a) Clinical PK DDI study: Both single drug and drug combination exposures (i.e., pharmacokinetics) are evaluated either in patients or healthy volunteers |
b) Clinical PK PG study: The single drug exposure (i.e., pharmacokinetics) is evaluated among patients who have different genotypes in CYP450 and UGT enzymes and drug transporters | |
c) In vitro PK study: Substrate depletion and metabolite formation study are for the fm data collection, and inhibition study is for the Ki data collection | |
d) Drug interaction detection algorithms or software | |
e) Compliance of avoiding DDIs | |
f) Concordance of DDI reporting among different drug interaction knowledge base | |
g) Comparison of tde performance of DDI clinical decision systems | |
h) Drug–alcohol/food interactions | |
i) Drug/test interactions | |
j) Case report studies | |
k) Review papers | |
l) Cell culture and animal studies | |
m) Other studies that are not related to drug interactions |