ACoP 2015 Poster: Towards data standards, supporting quantitative approaches in drug development

Datasets for pharmacometric analyses: internal review and standardization efforts

Andrijana Radivojevic, Henning Schmidt, Novartis
Sixth American Conference on Pharmacometrics (ACoP6), 2015

Background & Objective
Analysis datasets for the conduct of pharmacometric (PMX) analyses are usually prepared by the modeler him/herself or requested from a supporting programming group. The content and the structure of such datasets are defined in a dataset specification. There are currently no standards in this regards, and therefore the dataset structure typically depends on the modeling activity, the modeling tool, the models to be assessed, and even on the modeler. This kind of freedom is directly translated into lower efficiency in dataset preparation process, multiple iterations between modelers and programmers, and compromised quality of the of delivered analysis dataset.
Standards, however, could considerably improve the process of dataset specification, preparation, and allow for automated dataset quality checks. The goal of this work is to analyze the typical content of PMX datasets, reasons for their variability, and to assess if and how standardization in this context might be feasible.

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