Abstract
The lack of standardization in the way that quantitative and systems pharmacology (QSP) models are developed, tested, and documented hinders their reproducibility, reusability, and expansion or reduction to alternative contexts. This in turn undermines the potential impact of QSP in academic, industrial, and regulatory frameworks. This article presents a minimum set of recommendations from the UK Quantitative and Systems Pharmacology Network (UK QSP Network) to guide QSP practitioners seeking to maximize their impact, and stakeholders considering the use of QSP models in their environment.
Highlights
The lack of standardization in the way that quantitative and systems pharmacology (QSP) models are developed, tested, and documented hinders their reproducibility, reusability, and expansion or reduction to alternative contexts
QSP is gaining traction against the background of the exponential increase in the number of QSP publications in scientific journals since the release of two seminal papers[1,2], the emergence of the first scholarly journal dedicated to systems pharmacology,[3] and the growing number of mathematical models of biology readily available through public databases (BioModels,[4] cell markup language (CellML),[5] DDMore6)
Published models tend to be generated de novo rather than being the result of an expansion or modification of existing models. This situation is, to a significant extent, because of the lack of standardization in the way that QSP models are developed, tested, and documented when made available to the public community, which hinders their reproducibility, reusability, and expansion or reduction to alternative contexts. This gap has been somewhat quantified by Kirouac et al.,[8] who found that only 4 out of 12 model code files published in CPT: Pharmacometrics & Systems Pharmacology until October 2018 was executable
Summary
Best Practices to Maximize the Use and Reuse of Quantitative and Systems Pharmacology Models: Recommendations From the United Kingdom Quantitative and Systems Pharmacology Network. This situation is, to a significant extent, because of the lack of standardization in the way that QSP models are developed, tested, and documented when made available to the public community, which hinders their reproducibility, reusability, and expansion or reduction to alternative contexts This gap has been somewhat quantified by Kirouac et al.,[8] who found that only 4 out of 12 model code files published in CPT: Pharmacometrics & Systems Pharmacology until October 2018 was executable. The overall result from this state of affairs is a general lack of confidence in the models which coupled with their perceived highly technical nature, can undermine the trust that the bench-based community and decision makers may have in QSP as a discipline This situation implies the need for a significant use of resources (industrial and academic, time-and cost-wise) in trying to implement, reapply, or further develop models of questionable reproducibility and/or reusability. If physiologically-based pharmacokinetic (PBPK) models are considered a special case of QSP modeling, it is important to mention the recent efforts by both the European Medicines Agency (EMA)[30,31] and the FDA.[22,32]
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