JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

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Activity Number: 280
Type: Contributed
Date/Time: Tuesday, August 4, 2009 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #304302
Title: Diagnostics for Logistic Regression on AE Data
Author(s): Bo Jin*+
Companies: Merck Research Laboratories
Address: 351 N Sumneytown Pike, UG1C-36, North Wales, PA, 19454,
Keywords: Adverse Event ; Logistic Regression ; Model Diagnostics
Abstract:

In the past few years, pharmacokinetics (PK) and adverse events (AE) modeling has played a more and more important role in dose selection and drug safety evaluation in clinical trials. Linear or nonlinear logistic regression is usually employed to explore the relationship between AE occurrence and a specific PK valuable. However, there is lack of guidance how to evaluate linear or nonlinear logistic regression on AE data. This communication introduces several diagnostics methods including residual vs. predicted value plot, residual normal quantile plot, and local mean deviance plot. These methods will be discussed in both linear and nonlinear logistic regression modeling through the analyses of simulated and real data.


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Revised September, 2008