|
Abstract:
|
The microsampling technologies of dried blood spots (DBS) in an outpatient setting coupled with sensor enabled time-stamps for collection of PK is being evaluated through clinical trials. If DBS could replace the traditional plasma sample collection in clinic, it would increase the usability of PK sampling data collected from clinical studies, significantly augment the PK, exposure-response, and clinical information we access from clinical trials, and increase flexibility in trial visits and reduce logistic burden for clinical trials. In this talk, we will apply several commonly used statistics indexes including Intraclass Correlation Coefficient (ICC), Concordance Correlation Coefficient (CCC) and a recently published new method CCC for repeated measurements, to evaluate the agreement of drug concentrations measured from plasma samples collected in-clinic with traditional methods versus that measured from blood samples using the technology of DBS in an outpatient setting. A simulation study will also be performed to further evaluate the performance of these three indexes.
|
