Abstract

Purpose: The current implementation of a pharmacometric process has, in most cases, grown from the ad hoc application of modeling and simulation activities to the drug-development process. This ad hoc implementation gives rise to a number of serious deficiencies that currently obstruct the optimal performance and application of pharmacometrics. The accelerating shift from empirical to model-based development strategies – and the growing reliance on modeling and simulation in decision-making will require the successful transformation of the pharmacometrics enterprise to a critical path service sufficiently provisioned to operate at the requisite level of efficiency, effectiveness, and reliability. We propose to use enterprise engineering methods and techniques to perform a systematic analysis of the current pharmacometrics operating environment in order to address critical unmet systematic, informatic, and processual needs of the pharmacometric process.

Population Approach Group in Europe (PAGE); Copenhagen, Denmark; June 2007

By Thaddeus H. Grasela