Merck & Co., Inc. (Kenilworth, New Jersey) has recently published an integrated 
strategy for implementation of dried blood spots (DBS) in late-stage trials for 
population pharmacokinetic (PK) modeling. We applied this strategy for another 
late-stage clinical program: ubrogepant (MK-1602), a novel oral calcitonin 
gene-related peptide receptor antagonist for acute treatment of migraine. At the 
time of implementation, ubrogepant was entering phase 2 development. DBS was 
implemented to acquire PK information proximal to an acute migraine event to 
enable exposure-response modeling. The clinical endpoint was a spontaneous 
event, which generally occurs outside a clinic visit. Thus, an innovative 
feature of this trial was facilitating DBS in an outpatient setting. In vitro 
and bioanalytical tests established initial method feasibility and suitability 
for further evaluations in the clinic. A quantitative relationship was developed 
between blood and plasma concentrations from concurrently collected samples in a 
phase 1 (healthy subjects) and phase 2 (target patient population) study using 
graphical and population PK approaches. This integrated information was 
presented to the Food and Drug Administration for regulatory input. Following 
regulatory concurrence, DBS was poised for use in further clinical studies. 
Population PK modeling was used to dissect sources of variability contributing 
to DBS collection in the outpatient setting. What has been learned from this 
program has informed the broader integrated strategy of Merck & Co., Inc. 
(Kenilworth, NJ) for DBS implementation in clinical trials and research to 
improve the precision of PK data collected in an outpatient setting.