title: Validation of assay methodology used in pharmacokinetic studies.
abstract: Statistical methods for validating assays used in pharmacokinetic studies are discussed. Methods for assessing linearity, variability, and sensitivity are derived. It is proposed that a calibration experiment, in which samples are replicated at three different concentrations, will provide the necessary information to validate an assay prior to commencement of a pharmacokinetic study and during its routine use. A two-stage weighted least squares regression is used to analyze the calibration data. High performance liquid chromatography calibration data are used to illustrate the principles and techniques involved.
mesh_terms: D002851:Chromatography, High Pressure Liquid; D007700:Kinetics; D008750:Methyldopa / Q000032:analysis; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000378:metabolism*; D012984:Software; D013223:Statistics as Topic; D014859:Warfarin / Q000032:analysis
chemical_list: D004364:Pharmaceutical Preparations; D008750:Methyldopa; D014859:Warfarin