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DDMODEL00000002: Friberg_2009_Schizophrenia_Asenapine_PANSS

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Modeling and simulation of the time course of asenapine exposure response and dropout patterns in acute schizophrenia. Friberg LE, de Greef R, Kerbusch T, Karlsson MO Clinical pharmacology and therapeutics, 7/2009, Volume 86, Issue 1, pages: 84-91
PharmML (0.3.1)
  • Modeling and simulation of the time course of asenapine exposure response and dropout patterns in acute schizophrenia.
  • Friberg LE, de Greef R, Kerbusch T, Karlsson MO
  • Clinical pharmacology and therapeutics, 7/2009, Volume 86, Issue 1, pages: 84-91
  • Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden. lena.friberg@farmbio.uu.se
  • Modeling and simulation were utilized to characterize the efficacy dose response of sublingual asenapine in patients with schizophrenia and to understand the outcomes of six placebo-controlled trials in which placebo responses and dropout rates varied. The time course of total Positive and Negative Syndrome Scale (PANSS) scores was characterized for placebo and asenapine treatments in a pharmacokinetic-pharmacodynamic model in which the asenapine effect was described by an E(max) model, increasing linearly over the 6-week study period. A logistic regression model described the time course of dropouts, with previous PANSS value being the most important predictor. The last observation carried forward (LOCF) time courses were well described in simulations from the combined PANSS + dropout model. The observed trial outcomes were successfully predicted for all the placebo arms and the majority of the treatment arms. Although simulations indicated that the post hoc probability of success of the performed trials was low to moderate, these analyses demonstrated that 5 and 10 mg twice-daily (b.i.d.) doses of asenapine have similar efficacy.
Zinnia Parra-Guillen
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  • Model owner: Zinnia Parra-Guillen
  • Submitted: Sep 25, 2014 5:58:08 PM
  • Last Modified: May 18, 2016 7:42:15 PM
Revisions
  • Version: 7 public model Download this version
    • Submitted on: May 18, 2016 7:42:15 PM
    • Submitted by: Zinnia Parra-Guillen
    • With comment: Updated model annotations.
  • Version: 4 public model Download this version
    • Submitted on: Dec 10, 2015 4:53:00 PM
    • Submitted by: Zinnia Parra-Guillen
    • With comment: Edited model metadata online.
  • Version: 2 public model Download this version
    • Submitted on: Sep 25, 2014 5:58:08 PM
    • Submitted by: Zinnia Parra-Guillen
    • With comment: Harmonised PharmML, MDL and NM-TRAN and used of established nomenclature
 
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