Funatogawa Takashi, Funatogawa Ikuko
Vanderbilt-Ingram Cancer Center, Cancer Biostatistics Center, Nashville, Tennessee 37232-6838, USA.
J Biopharm Stat. 2012;22(1):43-53. doi: 10.1080/10543406.2010.502983.
In clinical trials, sometimes only a single drug concentration can be measured from a patient, because of the burden on the patient. From a single concentration, we cannot generally obtain point estimates of each pharmacokinetic parameter in a patient. In this article, we propose a method to estimate the clearance using a one-compartment model of a single-bolus intravenous injection from a single concentration at a sampling point between 1.5 and 2.5 half-lives. This method requires an assumed value for the volume of distribution but is robust to misspecification. This approach is illustrated by simulated concentration data and cadralazine concentration data.