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Activity Number: 609
Type: Contributed
Date/Time: Wednesday, August 12, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract #316725
Title: Study Design and Data Analysis for Pharmacokinetics in Patients with Impaired Renal/Hepatic Function
Author(s): Xiaoli Hou*
Companies:
Keywords: Impaired Renal Function ; Interaction ; Pharmacokinetics ; ANOVA ; ANCOVA ; Impaired hepatic function
Abstract:

After entering the body, a drug is usually eliminated by excretion and/or by metabolism, which mainly involves renal/hepatic function. Impaired renal/hepatic function usually alters the drug's pharmacokinetics (PK) to an extent that the dosage regimen needs to be changed from that used in patients with normal renal/hepatic function. Since the PK is most likely to be affected by both rental/hepatic function and demographic aspects, the study usually includes a healthy volunteer control group whose demographic data matches the typical impaired renal/hepatic function group. FDA guidance gives the recommendations when a study of PK in patients with impaired renal function should be performed as a full study or a reduced study and when it is not necessary. However, it does not give details about matching and modeling/analysis. This presentation reviews the most popular designs, and modeling/analysis options. Ideally, an ANOVA model is used if the control group matches the impaired renal/hepatic function group perfectly; otherwise, an ANCOVA model is considered for removing the unmatched demographic effect. Presenting real clinical studies, we show the ANCOVA model results can be biased


Authors who are presenting talks have a * after their name.

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