Profile photo of Wendy Aartsen

New thoughtflow publication is out in CPT:PSP

WHITE PAPER
JJ Wilkins, PLS Chan, J Chard, G Smith, MK Smith, M Beer, A Dunn, C Flandorfer, C Franklin, R GomeniL Harnisch, R Kaye, S Moodie, ML Sardu, E Wang, E Watson, K Wolstencroft, SYA Cheung * on behalf of the DDMoRe Consortium
Pharmacometric analyses are complex and multifactorial. It is essential to check, track, and document the vast amounts of
data and metadata that are generated during these analyses (and the relationships between them) in order to comply with
regulations, support quality control, auditing, and reporting. It is, however, challenging, tedious, error-prone, and time-
consuming, and diverts pharmacometricians from the more useful business of doing science. Automating this process would
save time, reduce transcriptional errors, support the retention and transfer of knowledge, encourage good practice, and help
ensure that pharmacometric analyses appropriately impact decisions. The ability to document, communicate, and reconstruct
a complete pharmacometric analysis using an open standard would have considerable benefits. In this article, the Innovative
Medicines Initiative (IMI) Drug Disease Model Resources (DDMoRe) consortium proposes a set of standards to facilitate the
capture, storage, and reporting of knowledge (including assumptions and decisions) in the context of model-informed drug
discovery and development (MID3), as well as to support reproducibility: ‘‘Thoughtflow.’’ A prototype software implementation
is provided.

Leave a Reply

Your email address will not be published. Required fields are marked *