Practical recommendations for population PK studies with sampling time errors.

ABSTRACT:

Purpose

Population pharmacokinetic (PK) data collected from routine clinical practice offers a rich source of valuable information. However, in observational population PK data, accurate time information for blood samples is often missing, resulting in measurement errors (ME) in the sampling time variable. The goal of this study was to investigate the effects on model parameters when a scheduled time is used instead of the actual blood sampling time, and to propose ME correction methods.

Methods

Simulation studies were conducted based on two major factors: the curvature in PK profiles and the size of ME. As ME correction methods, transform both sides (TBS) models were developed with application of Box-Cox power transformation and Taylor expansion. The TBS models were compare

SUBMITTER: Choi L 

PROVIDER: S-EPMC3891525 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature