Parent drug or active metabolite?Are the relevant analytes limited to the parent drug, or should active metabolites, prodrug conversion products, or glucuronide conjugates also be included?
CYP metabolism involved?Is CYP-mediated biotransformation a major clearance route, and should metabolite profiling or CYP phenotyping be part of the study?
Transporter interactions?Does the drug interact with OATP, P-gp, or other transporters that affect disposition, tissue exposure, or DDI risk?
Parent-metabolite ratios?Are parent-to-metabolite ratios meaningful for interpreting exposure, bioactivation, or clearance in the study context?
Coagulation or platelet readouts?For anticoagulants or antiplatelet agents, are coagulation parameters, platelet function indicators, or related biomarkers needed?
Lipid or vascular response markers?Are lipid pathway biomarkers, vascular function indicators, or cardiac response markers needed alongside exposure data?