AAPS Short Course on Computer Simulation and Its Role in Drug Development Research

January 28-29, 2002 — Rescheduled Date
Crystal Gateway Marriott
Arlington, VA

Preliminary Program

Day One
Day Two

Day One

7:00 am - 5:00 pm
Registration

8:00 am - 8:15 am
Introduction: Modeling Versus Simulation and Applications
Peter L. Bonate, Ph.D.
Quintiles, Inc.

Introduction to Monte Carlo Simulation

8:15 am - 8:45 am
Random Number Generation (RNG)
Peter L. Bonate, Ph.D.
Quintiles, Inc.

8:45 am - 9:15 am
Random Variate Generation: Continuous and Discrete Distributions
Peter L. Bonate, Ph.D.
Quintiles, Inc.

9:15 am - 9:45 am
Choosing the Inputs
Ene I. Ette, Ph.D.
Vertex Pharmaceuticals

9:45 am - 10:00 am
Break

10:00 am - 10:30 am
Analysis of the Outputs
Ene I. Ette, Ph.D.
Vertex Pharmaceuticals

10:30 am - 11:00 am
Qualification of Simulation Models
Hui C. Kimko, Ph.D.
Georgetown University Medical Center for Drug Development Science

11:00 am - 11:30 am
Developing a Simulation Plan
Hui C. Kimko, Ph.D.
Georgetown University Medical Center for Drug Development Science

11:30 am - 11:45 am
Panel Discussion

11:45 am - 12:45 pm
Lunch (Complimentary to all registrants)

12:45 pm - 1:30 pm
Regulatory Review of Simulation Results
Peter I.D. Lee, Ph.D.
Food and Drug Administration

1:30 pm - 2:15 pm
Software Selection
Laurence Levasseur, Ph.D.
Quintiles, Inc.

2:15 pm - 2:45 pm
Break

Basic Examples

2:45 pm - 3:45 pm
Example 1: Modeling and Simulation as a Tool to Integrate PK/PD Knowledge Across an NDA for Regulatory Decision Making: A Case Study
Jogarao J. Gobburu
Food and Drug Administration

3:45 pm - 4:45 pm
Example 2: Gastrointestinal Absorption
Walter S. Woltosz
Simulation Plus, Inc.

4:45 pm - 5:00 pm
Panel Discussion

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Day Two

7:30 am - 5:00 pm
Registration

8:00 am - 9:15 am
Case Studies in Clinical Trial Simulation: Study 1
Raymond Miller
Pfizer Global Research and Development

9:15 am - 10:30 am
Case Studies in Clinical Trial Simulation: Study 2
Pharsight Corporation

10:30 am - 10:45 am
Break

10:45 am - 12:00 pm
Case Studies in Clinical Trial Simulation: Study 3
Mark Sale
GlaxoSmithKline

12:00 pm - 12:30 pm
Panel Discussion

12:30 pm - 1:30 pm
Lunch (Complimentary to all registrants)

1:30 pm - 4:00 pm
Exhibitor Product Demonstrations
Poster Session

4:00 pm - 5:00 pm
Panel Discussion with Poster Presenters
Final Questions and Wrap-Up

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