منابع مشابه
Integration of PKPD relationships into benefit-risk analysis.
AIM Despite the continuous endeavour to achieve high standards in medical care through effectiveness measures, a quantitative framework for the assessment of the benefit-risk balance of new medicines is lacking prior to regulatory approval. The aim of this short review is to summarise the approaches currently available for benefit-risk assessment. In addition, we propose the use of pharmacokine...
متن کاملPKPD Modeling of Predictors for Adverse Effects and Overall Survival in Sunitinib-Treated Patients With GIST
A modeling framework relating exposure, biomarkers (vascular endothelial growth factor (VEGF), soluble vascular endothelial growth factor receptor (sVEGFR)-2, -3, soluble stem cell factor receptor (sKIT)), and tumor growth to overall survival (OS) was extended to include adverse effects (myelosuppression, hypertension, fatigue, and hand-foot syndrome (HFS)). Longitudinal pharmacokinetic-pharmac...
متن کاملevaluation of adaptive and non-linear pkpd Models for bivalirudin in post- cardiac surgical patients
58 Figure 1. Nonlinear PKPD model (panel A) with an adaptive gain KPTT. As shown in a sample patient (panels B and C), the addition of the adaptive feature improves the fit. The rootmean square (RMS) error decreases from 9.6 to 8.5 (s) in this patient.
متن کاملMathematical analysis of the pharmacokinetic-pharmacodynamic (PKPD) behaviour of monoclonal antibodies: predicting in vivo potency.
We consider the relationship between the target affinity of a monoclonal antibody and its in vivo potency. The dynamics of the system is described mathematically by a target-mediated drug disposition model. As a measure of potency, we consider the minimum level of the free receptor following a single bolus injection of the ligand into the plasma compartment. From the differential equations, we ...
متن کاملCombining Nonclinical Experiments with Translational PKPD Modeling to Differentiate Erlotinib and Gefitinib.
We quantitatively compare the efficacy of two approved EGFR tyrosine kinase inhibitors, erlotinib and gefitinib, based on in vivo and in vitro data and show how a modeling approach can be used to scale from animal to humans. Gefitinib shows a higher tumor uptake in cancer patients, and we explored the potential impact on pharmacologic and antitumor activity in in vitro and in xenograft mice. Tu...
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ژورنال
عنوان ژورنال: Intensive Care Medicine
سال: 2015
ISSN: 0342-4642,1432-1238
DOI: 10.1007/s00134-015-4032-6