Optimal selection procedures for abbreviated area under the curve (AAUC) of blood concentration versus time for drug blood concentration levels.
It has become common to collect blood samples from patients for phase II/III clinical trials to investigate pharmacokinetic/pharmacodynamic relationships. However, the frequency of blood samples drawn from patients is limited due to clinical or pharmacoeconomic reasons. We discuss some sampling schemes for an immunosuppressive drug in phase III studies. Selection criteria and statistical approaches are discussed to select blood-sampling time points in four scenarios from a single study and from combined multiple studies: (1) Area under the curve (AUC) only without constraint, (2) AUC and Cmax simultaneously without constraint, (3) AUC only with constraint(s), and (4) AUC and Cmax simultaneously with constraint(s).
Chang
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CT
Baxter Pharmaceutical Products, Inc., Department of Biometrics, Liberty Corner, New Jersey, USA.
Wong
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RL
D019540:Area Under Curve; D001774:Blood Chemical Analysis; D002986:Clinical Trials as Topic / Q000379:methods*; D016903:Drug Monitoring / Q000379:methods*; D006801:Humans; D008432:Mathematical Computing; D015201:Meta-Analysis as Topic; D011237:Predictive Value of Tests