JSM 2012 Home

JSM 2012 Online Program

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

Online Program Home

Abstract Details

Activity Number: 192
Type: Contributed
Date/Time: Monday, July 30, 2012 : 10:30 AM to 12:20 PM
Sponsor: Section for Statistical Programmers and Analysts
Abstract - #306327
Title: Intersubject Variability in Pharmacokinetics and Subject Characteristics in Phase I Studies
Author(s): Peng Chai*+ and Chun Feng and Xiaopeng Li
Companies: Celerion and Celerion and Celerion
Address: 621 Rose Street, Lincoln, NE, 68502, United States
Keywords: Mixed-effects model ; pharmacokinetics ; intersubject variability ; subject characteristics

Pharmacokinetic (PK) and safety results of Phase 1 studies are assessed by pharmacokineticist and medical writer respectively with the statistician working on PK statistical modeling. The statistician can do more through analysis of intersubject variability in PK and subject characteristics. High intersubject variability in PK indicates variation in drug absorption, distribution, or elimination across subjects. Examination of subject characteristics predictive for differences in PK is then desirable. When a subject's PK responses are repeatedly measured, mixed-effects modeling can provide estimation of fixed-effects parameters, intersubject variability, and residual random effects (including intrasubject variability). After mixed ANOVA model, more interest is often on intrasubject CV for estimating power. The intersubject CV can also be derived. A high value (e.g., 30% or more) should lead to further study. For example, regression analysis or data visualization on laboratory tests for liver and renal functions can link PK and these subject characteristics. Thus, without a full population PK study, the statistician can perform some quick analyses on the drug's therapeutic potential.

The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.

Back to the full JSM 2012 program

2012 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.