Sponsored by the
Population Pharmacokinetics and Pharmacodynamics Focus Group


***************************************************************************************
*            Wednesday, February 10, 2009 from 12:30 - 2:00 pm EST
*
*
*                               The Full Covariate Models and WAM Algorithm:
*       Efficient Building of Covariate Models and Appropriate Inferences about 
Covariate Effects
*
*
*    Conducted by
*           Marc R. Gastonguay, Ph.D., Metrum Research Group & Metrum Institute
*           Kenneth G. Kowalski, M.S., Ann Arbor Pharmacometrics Group

*    Moderated by
*           Liping Zhang, Ph.D., Bristol-Myers Squibb
*
***************************************************************************************

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The Q&A Session will follow the formal lecture at approximately 1:15 pm EST. 
You may ask questions at any time during the webinar by typing them in to the 
question box on your screen. You may also ask questions in advance during the 
registration process.

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may download the presenter's handouts at:
http://mediaserver.aapspharmaceutica.com/meetings/webinars/ppdm-4/ppdm-4.pdf

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Description:

This presentation will provide an overview of Full Covariate Modeling method 
(Gastonguay, 2004) and Wald's Approximation Method (WAM) for covariate model 
building based on the methodology of Kowalski and Hutmacher (2001). An example 
will be used to illustrate application of the WAM algorithm and the value 
obtained from evaluating all reduced models among the complete set of possible 
hierarchical covariate models leading to a parsimonious final model. The 
presentation will also illustrate the utility of the Full Covariate Model 
approach for inference about covariate effects and some possible strategies for 
the successful development of a full model necessary to employ the WAM approach 
and subsequent model-based simulation goals. The presentation will highlight 
the advantages and disadvantages of the Full Covariate Model approach and WAM 
approach and in comparison to standard stepwise procedures. The presentation 
will conclude with a discussion of the available software to implement the WAM 
algorithm and Full Covariate Model.

The WAM algorithm was first published in 2001; however, it has not been widely 
used in the modeling community in part because it requires the development of a 
full model. At the time of its introduction, development of a full model in 
which all covariate effects are estimated simultaneously was not routinely 
performed. Today, there is a greater appreciation of the value in developing 
full models, particularly for inferential purposes regarding covariate effects. 
This webinar will present two promising approaches for covariate model building 
that leverage information from a full model as alternatives to standard 
stepwise procedures.

Goals and Objectives:
*       To provide an overview of the goals of covariate modeling in the drug 
development process;
*       To provide an overview of Full Covariate Model and WAM algorithm 
approaches relative to traditional Stepwise Regression, define advantages and 
disadvantages of each method as a function of covariate modeling objectives in 
drug development;
*       To promote an awareness of the methodologies and the available software.



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