Evaluation of Assumptions Underpinning Pharmacometric Models

Author:

Ooi Qing-XiORCID,Wright Daniel F. B.,Isbister Geoffrey K.,Duffull Stephen B.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference21 articles.

1. Marshall SF, Burghaus R, Cosson V, Cheung SY, Chenel M, DellaPasqua O, et al. Good practices in model-informed drug discovery and development: practice, application, and documentation. CPT Pharmacometrics Syst Pharmacol. 2016;5(3):93–122.

2. Food and Drug Administration (FDA). Guidance for industry: population pharmacokinetics 1999 [Available from: https://www.fda.gov/downloads/drugs/guidances/UCM072137.pdf . Accessed 15 April 2019.

3. European Medicines Agency (EMA). Guideline on reporting the results of population pharmacokinetic analyses 2007 [Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003067.pdf . Accessed 15 April 2019.

4. Manolis E, Brogren J, Cole S, Hay JL, Nordmark A, Karlsson KE, et al. Commentary on the MID3 good practices paper. CPT Pharmacometrics Syst Pharmacol. 2017;6(7):416–7.

5. Byon W, Smith MK, Chan P, Tortorici MA, Riley S, Dai H, et al. Establishing best practices and guidance in population modeling: an experience with an internal population pharmacokinetic analysis guidance. CPT Pharmacometrics Syst Pharmacol. 2013;2:e51.

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