Population pharmacokinetics with a very small sample size.
The objective of this study was to evaluate whether pharmacokinetic parameters (clearance and volume of distribution of the central compartment) from a sparse sampling population pharmacokinetic study can be obtained with a very small sample size. For this study, three drugs were selected from the literature. The pharmacokinetics of all three drugs were studied in healthy adult subjects and plasma concentrations versus time data for individual subjects from extensive blood sampling were available. For population PK analysis, only five subjects were chosen and each subject gave either one or two blood samples. The estimated PK parameters from population PK analysis were compared with the PK parameters obtained from extensive sampling. The results of the study indicated that a reasonable estimate of PK parameters can be obtained with two blood samples from each subject with a sample size of five. The population PK study with sparse sampling scheme may be useful for PK studies in neonates and very young children and in subjects with rare diseases where sample size is small.
Mahmood
Iftekhar
I
Office of Blood Review & Research, Center for Biologic Evaluation and Research, Food & Drug Administration, Rockville Pike, MD 20852, USA. iftekhar.mahmood@fda.hhs.gov
Duan
John
J
D000328:Adult; D000900:Anti-Bacterial Agents / Q000097:blood; D000959:Antihypertensive Agents / Q000097:blood; D017298:Bisoprolol / Q000097:blood; D001800:Blood Specimen Collection / Q000379:methods*; D002121:Calcium Channel Blockers / Q000097:blood; D002439:Cefotaxime / Q000031:analogs & derivatives / Q000097:blood; D006801:Humans; D009543:Nifedipine / Q000097:blood; D010599:Pharmacokinetics; D018401:Sample Size
D000900:Anti-Bacterial Agents; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D009543:Nifedipine; D002439:Cefotaxime; D017298:Bisoprolol; C033356:cefodizime