Definition of Time of Occurrence of Cmax (Tmax) of Liraglutide in Clinical Trial Data

Details

This page serves as a reference for an 'EvidenceVariable' published on the Fast Evidence Interoperability Resources (FEvIR) Platform. It defines a specific biomarker measurement—the Time of Occurrence of Cmax (Tmax) of Liraglutide—from the clinical trial NCT01725126, structured in FHIR format. The background involves complex data collection: blood samples were taken on Day -1 and Day 42. These samples spanned multiple time points, from pre-dose (0 hours) up to 24 hours post-dose (including intervals like 15 minutes, 30 minutes, 1 hour, etc.). Because the observation of Cmax requires direct determination from raw concentration-time data based on this complex sampling schedule, defining this variable is crucial for standardizing measurement and ensuring interoperability. This resource is structured as an FHIR EvidenceVariable Resource and links to multiple associated outcome measures and research studies (e.g., FOI 376463, FOI 2816). This capability allows the consistent exchange and utilization of pharmacokinetic/pharmacodynamic (PK/PD) measurement variables across different systems. In Japanese healthcare IT, such standardized definitions for biomarkers and test results are critically important. By utilizing international standards like FHIR, it provides a foundation for research institutions and hospitals to seamlessly share complex clinical data, facilitating advanced personalized medicine and pharmacokinetics analysis.