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. 2020 Apr;9(4):195-197.
doi: 10.1002/psp4.12504. Epub 2020 Apr 1.

Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges

Flora T Musuamba  1   2   3 , Roberta Bursi  4 , Efthymios Manolis  1   5 , Kristin Karlsson  1   6 , Alexander Kulesza  7 , Eulalie Courcelles  7 , Jean-Pierre Boissel  7 , Raphaëlle Lesage  8 , Cécile Crozatier  9 , Emmanuelle M Voisin  9 , Cécile F Rousseau  9 , Thierry Marchal  10 , Rossana Alessandrello  11 , Liesbet Geris  8   12
Affiliations

Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges

Flora T Musuamba et al. CPT Pharmacometrics Syst Pharmacol. 2020 Apr.
No abstract available

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Conflict of interest statement

The authors declared no competing interests for this work.

References

    1. Piñero, J. , Furlong, L.I. & Sanz, F. In silico models in drug development: where we are. Curr. Opin. Pharmacol. 42, 111–121 (2018). - PubMed
    1. Madabushi, R. et al The US Food and Drug Administration's model‐informed drug development paired meeting pilot program: early experience and impact. Clin. Pharmacol. Ther. 106, 74–78 (2019). - PubMed
    1. The Report From the Expert Group on (Quantitative) Structure‐Activity Relationships on the Principles for the Validation of (Q)SARs. Paris, France: Organization for Economic Co‐operation and Development (OECD) Expert Group on QSARs; <http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env...> (2004). Accessed December 19, 2019.
    1. Committee for Medicinal Products for Human Use (CHMP) . Guideline on reporting the results of population pharmacokinetic analysis <https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-re...>. Accessed December 19, 2019.
    1. US Food and Drug Administration (FDA) . Exposure‐response relationships — study design, data analysis, and regulatory applications. <https://www.fda.gov/regulatory-information/search-fda-guidance-documents...>. Accessed December 19, 2019.

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