JSM 2005 - Toronto

Abstract #302667

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 345
Type: Invited
Date/Time: Wednesday, August 10, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #302667
Title: Role of Mechanistically-based PK/PD Models in Drug Development: A Case Study
Author(s): Niclas Jonsson*+
Companies: Uppsala University
Address: , , ,
Keywords:
Abstract:

Pharmacokinetic (PK) and pharmacodynamic (PD) modeling have been proposed as very valuable in drug development. One reason for this is the possibility to use the models as predictive simulation tools to forecast and optimize future clinical trials. Another reason is that modeling, or more precisely model development, creates a level of understanding and insight into a system of interest that is hard to achieve with other approaches. The learning aspect of modeling becomes even more pronounced if the model is mechanistic or mechanistically based. The main drawbacks with modeling in drug development, on the other hand, are that it takes time---especially if the model is complicated (i.e., mechanistic)---and that a model-based analysis can be perceived as less objective than traditional modes of analysis. This paper concerns the application of mechanistically based PK/PD models in drug development. It is based on a real life example and will show how practical aspects such as time constraints and project team feedback were handled and how the modeling added value to the project.

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Revised March 2005