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Elena Soto1,7, Ron J Keizer2,7, Iñaki F. Trocóniz1, Alwin DR Huitema2,4, Jos H Beijnen2,3,4, Jan HM Schellens3,4, Jantien Wanders 5, Josep María Cendrós6, Rosendo Obach6, Concepción Peraire6, Lena E Friberg7, Mats O Karlsson7 Predictive ability of a semi-mechanistic model for neutropenia in the development of novel anti-cancer agents: two case studies using diflomotecan and indisulam
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Karl Brendel, Laetitia Canini and Marylore Chenel Population pharmacokinetics-pharmacodynamics modeling of the QTc prolongation of Moxiflovoxacin and Levofloxacin in healthy volunteers: selection of the positive control in mandatory QT/QTc studies
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R. H. Leary Quasi-Monte Carlo EM Methods for NLME Analysis
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Thuy Vu, Edward Lee, Naren Narayanan, Graham Jang, and Peiming Ma Predicting Free Sclerostin from Free AMG 785 and Total Sclerostin
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G. Würthwein(1), C. Young (1), C. Lanvers-Kaminsky(2), G. Silling(3), G. Hempel(2,4), J. Boos(2), A. H. Groll(2) Population Pharmacokinetics of Liposomal Amphotericin B, Caspofungin and the Combination of Both in Allogeneic Hematopoietic Stem Cell Recipients
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Chao Chen Test Of Concept By Simulation: Comparing Response-Rate Findings Between Parallel And Titration Designs
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Leonid Gibiansky, Ekaterina Gibiansky Bias and Precision of Parameter Estimates: Comparison of Nonmem 7 Estimation Methods and PFIM 3.2 Predictions on the Example of Quasi-Steady-State Approximation of the Two-Target Target-Mediated Drug Disposition Model
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Leonid Gibiansky, Ekaterina Gibiansky Target-Mediated Drug Disposition: New Derivation of the Michaelis-Menten Model, and Why It Is Often Sufficient for Description of Drugs with TMDD
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Leonid Gibiansky, Ekaterina Gibiansky TMDD Model for Drugs that Bind Soluble and Membrane-Bound Targets: Can Quasi-Steady-State Approximation Estimate Unobservable Membrane-Bound Target Occupancy?
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Aristides Dokoumetzidis, Richard Magin, Panos Macheras Fractional kinetics in multi-compartmental systems
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Emmanuelle Comets, France Mentré Using simulations-based metrics to detect model misspecifications
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Johan E. Wallin(1,2), Martin Bergstrand(1), Mats O. Karlsson(1), Henryk Wilczek(3), Christine E. Staatz(1,4) Internal and external validation with sparse, adaptive-design data for evaluating the predictive performance of a population pharmacokinetic model of tacrolimus
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Jacob Brogren(1) Svante Nyberg(2) Transit Compartment Model Useful for Describing Absorption of Quetiapine XR and IR
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Callies Sophie 1, Andre Valerie 2, Patel Bharvin 3, Waters David 4, Francis Paul 5, Lahn Michael 6, De Alwis Dinesh 7, Slapak Christopher 8. Integration of preclinical data to support the design of the first in-man study of LY2181308, a second generation antisense oligonucleotide.
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Jackson K (1), Chedid M (2), Evans R (2) Troconiz IF(3) A Novel PKPD Model to Describe the Interaction of Drug Response of Combination Therapy: An Application in Preclinical Oncology.
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Emilie Hénin, Mats O. Karlsson Semi-physiological modeling of absorption kinetics: application to diclofenac
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Jeroen Elassaiss-Schaap Allometric scaling in oncology disease progression from xenograft tumor growth to human non-small-cell lung cancer
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C.B. Landersdorfer (1), D. London (1), R. Meng (1), C. Lin (1), S. Lin (1), C.-U. Lim (1), L. Queimado (2), S.A. Mousa (3), G.L. Drusano (4), A. Louie (4), F.B. Davis (1), H.-Y. Lin (1), P.J. Davis (1). Pharmacodynamic (PD) Modelling of Anti-Proliferative Effects of Tetraiodothyroacetic Acid (Tetrac) on Human Cancer Cells
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M Boucher Imputation of missing variance data comparing Bayesian and Classical non- linear mixed effect modelling to enable a precision weighted meta-analysis.
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W. Knebel*(1), T. Bergsma (1), C. Dagdigian (2), J. Hane (1), M. R. Gastonguay (1) A Strategy for Efficient Implementation of NONMEM 7 and the Intel Fortran Compiler in a Distributed Computing Environment
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Paul G Baverel, Kristin E Karlsson, Mats O Karlsson Informativeness of Internal and External Validation Techniques in Various Simulation Settings
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Brigitte D. Lacroix(1,2), Maria Laura Sargentini-Maier(2), Mats O. Karlsson(1) and Lena E. Friberg(1) Simultaneous modeling of the three ACR improvement thresholds – 20, 50 and 70% - in rheumatoid arthritis patients treated with certolizumab pegol
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D Renard, CH Hsu, M Dolker, V Yu, M Looby A trial simulation example to support the design and model-based analysis of a new dose and regimen finding study
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Michael R. Dunlavey Derivation of SAEM C-matrix in Phoenix
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Dickinson, GL Evaluation of a Method to Better Predict Human Absorption from Non-Clinical Data; Comparison of an in silico approach with population modelling of in vivo data
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F. Ezzet Analysis of Adverse Events using Literature Data: a Simulation Study
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F. Ezzet (1), J. Ribbing (2) Bronchial Allergen Challenge in Asthma: A Model for Inhaled Corticosteroids (ICS) and Montelukast using Literature Summary Data
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F. Ezzet (1), K. Prins (2), M. Boucher (3) Modeling Adverse Event rates of Opioids for the Treatment of Osteoarthritis Pain using Literature Data
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F. Musuamba (1), D. Teutonico (1), H.J. Maas (2), C. van Kesteren (1), A. Facius (3), S. Yang (2), M. Danhof (1), O. Della Pasqua (1,2) Evaluation of disease covariates in chronic obstructive pulmonary disease (COPD).
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FT Musuamba(1), M Mourad(2), V Haufroid(3), M De Mayer(3), Capron A(1), Delattre I(1), Verbeeck R(1), Wallemacq P(1) An optimal designed study for population pharmacokinetic modeling and Bayesian estimation of Mycophenolic acid and Tacrolimus early after renal transplantation
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Ron J Keizer, Robert S Jansen, Hilde Rosing, Jos H Beijnen, Jan HM Schellens, Alwin DR Huitema Incorporation of concentration data below the limit of quantification in population pharmacokinetic analyses
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RJ Keizer, Y Funahashi, T Semba, J Wanders, JH Beijnen, JHM Schellens, ADR Huitema Evaluation of clinical dosing of E7820 from preclinical and clinical data using a biomarker
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E. Chigutsa(1), H. McIlleron(1), N.H.G. Holford(2) Parallel first order and mixed order elimination of pyrazinamide in South African patients with tuberculosis
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Paolo Denti (1), Helen McIlleron (1) Modelling pre-dose concentrations in steady-state data. The importance of accounting for between-occasion variability and poor adherence.
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W. Krzyzanski An Interpretation of Transit Compartment Pharmacodynamic Models As Lifespan Based Indirect Response Models.
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Pinky Dua(1), Nicoletta Pons(2), Luigina Bertolotti(2), Clare Burgess(3), Roberto Gomeni(1) SB-773812: Correlation between in-silico and in-vivo metabolism
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Colomban O. (1)(2), Naudet B. (3), Maucort-Boulch D. (3), Roy P. (3), Girard P. (2) Toxicogenomic dose-response models for DNA chips data from rats treated by flutamide
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Kevin Le Boedec, Celine M. Laffont and Didier Concordet. A new solution to deal with eta-shrinkage: the Weighted EBEs!
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Joakim Nyberg, Sebastian Ueckert, Mats O. Karlsson, Andrew C. Hooker Global, exact and fast group size optimization with corresponding efficiency translation in optimal design
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Joakim Nyberg(1), Robert J. Bauer(2), Andrew C. Hooker(1) Investigations of the weighted residuals in NONMEM 7
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Ribba B,, Watkin E., Tod M., Girard P., Grenier E., You B., Wei M., Giraudo E., Freyer G. Combined analysis of tumor size data and histological biomarkers drives the development of a semi-mechanistic model of the effect of the antiangiogenic drug Sunitinib in mice
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M.R. Gastonguay(1), W.R. Gillespie(1), R.J. Bauer(2) Comparison of MCMC simulation results using NONMEM 7 or WinBUGS with the BUGSModelLibrary
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C. Ambery(1), M. Beerahee(1) Leveraging biomarker exposure-response in drug development
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R Jelliffe(1), M Neely(1), V Ozdemir(2) Pharmacogenomics and Individualized Dosage Regimens
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Kenneth T. Luu (1), Eugenia Kraynov (1) A Mechanistic Approach to Predicting Human Pharmacokinetics of Monoclonal Antibodies from Preclinical Data: A Case Example
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Ramusovic, S.(1), Willmann, S.(2), Frobel, A.-K.(1), Laeer, S.(1) An integrated whole-body physiology based pharmacokinetic/pharmacodynamic model of enalapril and the RAA-system
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Elodie L. Plan (1), Alan Maloney (1,2), France Mentré (3), Mats O. Karlsson (1), Julie Bertrand (3) Nonlinear Mixed Effects Estimation Algorithms: A Performance Comparison for Continuous Pharmacodynamic Population Models
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M. Campioni (1), S. Krösser (1), M.M. Thapar (2)*, S.C. Hayes (2), E. Gibiansky (3), V. Lucini (4), R. Anand (5), *Presenting author Population Pharmacokinetics of Safinamide and its Effect on Disease Progression in Parkinson's Disease
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D. Ternant(1), F. Lauféron(2), D. Mulleman(2), D. Wendling(3), E. Ducourau(2), C. Vignault(1), J.P. Valat(2), P. Goupille(2), G. Paintaud(1). Methotrexate influences neither pharmacokinetics nor concentration-effect relationship of infliximab in axial ankylosing spondylitis
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M. Meyer, L. Kuepfer, D. Chandra Prakash, S. Schneckener, B. Ludewig, J. Lippert Using relative gene expression measurements for PBPK modeling of pravastatin
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M. Meyer (1), S. Willmann (1), C. Becker (2), R. Burghaus (2), W. Mueck (2), J. Lippert (1) Influence of CYP1A1 induction by cigarette smoke on pharmacokinetics of erlotinib: a computer-based evaluation of smoke-induced CYP1A1 activity in different tissues
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Linus Görlitz, Michael Block, Jörg Lippert Identifying cancer drug MoAs and cell-line properties using signaling cascade models and Bayesian analysis: From throw-away experiments to persistent information
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Michael Block, Linus Görlitz, Clara Happ, Rolf Burghaus, Jörg Lippert Separating individual physiological variability from drug related properties using PBPK Modeling with PK-Sim® and MoBi® – Theophylline
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J. Tarning(1,2), R. Hoglund(3), P. Chotsiri(1), W. Hanpithakpong(1), A.P. Pyo(4), V. Jullien(5), N. Lindegardh(1,2), M. Rijken(4), I. Adam(6), F. Nosten(1,2,4) Population pharmacokinetics of antimalarial drugs in the treatment of pregnant women with uncomplicated malaria
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Elba M. Romero Tejeda, Nieves Vélez de Mendizábal, Iñaki F. Trocóniz Development of a mechanistic-based pharmacodynamic model to describe the effect of a prolonged administration of a GnRH agonist on testosterone levels
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Henry Pertinez, Leon Aarons Bayesian POP-PK analysis of exposure data from a Phase IIb clinical trial
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Valerii V. Fedorov, Sergei L. Leonov Optimization of sampling times for PK/PD models: approximation of elemental Fisher information matrix
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Venkata Pavan Kumar Vajjah, Stephen B Duffull Generalisation of T-optimality for discriminating between competing models - an application to paracetamol overdose
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C. Steven Ernest II and Andrew C. Hooker Predictor Identification in Time-to-Event Analyses
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Trame MN(1), Bartelink IH(2), Boos J(3), Boelens JJ(2), Hempel G(1,3) External Evaluation of a Population Pharmacokinetic Model for Dosing Busulfan in Children – Body Surface Area better than Body Weight
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Venkatesh Pilla Reddy*(1), Magdalena Kozielska(1), Martin Johnson(1), An Vermeulen(2), Rik de Greef(3), Jing Liu(4), Geny M.M. Groothuis(5), Meindert Danhof(6) and Johannes H. Proost(1) Modeling and Simulation of Placebo Response and Dropout Patterns in Treatment of Schizophrenia
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E. Yuen(1,2), I. Gueorguieva(1), L. Aarons(2) A population pharmacokinetic/pharmacodynamic model for duloxetine in diabetic peripheral neuropathy, plus methods for handling missing data.
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M. Andrew (1,2,3), M. Hebert (4,5), P. Vicini (1,6) Physiologically Based Pharmacokinetic (PBPK) Modeling of Midazolam Disposition in Pregnant and Postpartum Women
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Anne Drescher (1,2), Andreas Lindauer (1), Anne Christin Pieck (1), Günther Weber (3), Ralf A. Hilger (4), Dirk Strumberg (5), Max E. Scheulen (4), Ulrich Jaehde (1) Pharmacokinetic/Pharmacodynamic Modeling of Platinum-DNA-Adduct Formation in Leukocytes after Oxaliplatin Infusion
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Meg Bennetts Simulation Methodology for Quantitative Study Decision Making in a Dose Response Setting
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I. Ince[1,2], S.N. de Wildt[1], M.Y.M. Peeters[3], D.J. Murry[4], D. Tibboel[1], M. Danhof[2], C.A. Knibbe[1,2,3] Critical illness is a major determinant for midazolam and metabolite clearance in children
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I. Locatelli, M. Bogataj, A. Mrhar, I. Grabnar The Development of a Link Model Consisting of in vitro Drug Release and Tablets Gastric Emptying Time: Application to Diclofenac Enteric Coated Tablets
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Jan-Stefan Van Der Walt (1), Joe Standing (1), Mats O Karlsson (1), Per Lundborg (2), Tommy Andersson (2), Kerstin Röhss (2) and Marie Sandström (2) A population model describing the pharmacokinetics of iv esomeprazole in patients aged 0 to 17 years, inclusive
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Anne Dubois (1), Sigrid Balser (2), Sandro Gsteiger (3), Etienne Pigeolet (3) and France Mentré (1) Model-based bioequivalence analysis of recombinant human growth hormone using the SAEM algorithm: liquid or lyophilized formulations of Omnitrope® versus original lyophilized Genotropin®
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A. Dubois (1), S. Gsteiger (2), E. Pigeolet (2) and F. Mentré (1) Model-based bioequivalence analysis of pharmacokinetic crossover trials compared to standard non-compartmental analysis
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Xiaoyun Li, Andrew Lewandowski, Huafeng Zhou, A. Lawrence Gould, Kuenhi Tsai Estimation Comparison of Pharmacokinetic Models Using MONOLIX, PKBUGS, and NONMEM
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M. Frank (1), A. Kunz (2), G. Harms (2), JS. Van der Walt (3,4), C. Kloft (1) Population Pharmacokinetic Model Building for Mothers and Newborns using Additional Information from a Different Nevirapine Dataset
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J. G. Coen van Hasselt (1,2), Ron J. Keizer (1,2), M. van Benten (3), Alwin D. R. Huitema (1,2) Implementation of an affordable computing cluster for pharmacometric analysis
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J. G. Coen van Hasselt (1), Bruce Green (2), Glynn A. Morrish (3) Application of a semi-physiological model describing time-varying pharmacokinetics to support optimal clinical study design
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Amit Garg (1), Anis Khan (1), William Hanley (1), Janet van Adelsberg (1), Amy Ko (1), Elizabeth Quackenbush (1), Michael Crutchlow (1) and Sunny Chapel (2) A Mechanism Based Population Pharmacokinetic-Pharmacodynamic Model for Epoetin Alfa and Darbepoetin Alfa in Chronic Kidney Disease Patients
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W Smythe(1), H McIlleron(1), C Merle (2), J Horton(3), P Smith(1), and USH Simonsson(4) A Semi-Mechanistic pharmacokinetic enzyme model for the characterisation of rifampicin pharmacokinetics in South African pulmonary tuberculosis infected adults
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Toshihiro Wajima, Ryuji Kubota Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling for Integrase Inhibitors with a Simple Viral Dynamic Model
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Coulter CV,1 Joy JP,1 Duffull SB,1 Isbister GK2 Prediction of Torsades de Pointes from QT interval: analysis of a case series with amisulpride
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P. Välitalo[1], E. Kumpulainen[1], M. Manner [1], M. Laisalmi[2], M. Lehtonen[1], A. Hooker[3], V-P. Ranta[1], H. Kokki[2] Plasma and Cerebrospinal Fluid Pharmacokinetics of Naproxen in Children
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Rühs H(1), Panetta JC(2), Pui CH(2), Relling MV(2), Jaehde U(1) Homocysteine as biomarker in a semi-mechanistic PK/PD model of methotrexate
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Vincent F.S. Dubois1, Meriel Shearer1, Anne Chain1, Piet van de Graaf2, Mark Holbrook2, Derek Leishman3, David Gallacher4, Meindert Danhof1, Oscar Della Pasqua1,5 Translation of drug-induced QTc prolongation in early drug development.
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Magdalena Kozielska (1), Martin Johnson (1), Venkatesh Pilla Reddy (1), An Vermeulen (2), Rik de Greef (3), Cheryl Li (4), Sarah Grimwood (4), Jing Liu (4), Geny M. M. Groothuis (1), Meindert Danhof (5), Johannes H. Proost (1) Predictive performance of two PK-PD models of D2 receptor occupancy of the antipsychotics risperidone and paliperidone in rats
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Åsa M. Johansson, Sebastian Ueckert, Elodie L. Plan, Andrew C. Hooker, Mats O. Karlsson New Estimation Methods in NONMEM 7: Evaluation of Bias and Precision
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A. Mohamed (1), E.I. Nielsen (1), O. Cars (2) and L.E. Friberg (1). Predictions of Dosing Schedules of Gentamicin in Neonates Based on a Pharmacokinetic/Pharmacodynamic Model Considering Adaptive Resistance
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Thu Thuy Nguyen, Caroline Bazzoli, France Mentré Design evaluation and optimisation in crossover pharmacokinetic studies analyzed by nonlinear mixed effects models
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AK Hamberg (1), M Wadelius (1), M Pirmohamed (2), EN Jonsson (3)(4) Internal and external evaluation of a K-PD model for warfarin using prediction corrected visual predictive check (PC-VPC)
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Alexandre Sostelly (1), Léa Payen (2), Benjamin Ribba (3), Attilio Di Pietro (4), Pierre Falson (4), Pascal Girard (1,5), Michel Tod (1,6) Modelling the interaction between Irinotecan and efflux transporters inhibitors: A KPD tumour growth inhibition model including interaction components.
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C. Gérard (1,2), N. Bleyzac (3,4), P. Girard (1,2), G. Freyer (1,2), Y. Bertrand (3), M. Tod (1,2,5). Influence of cyclosporin dosing schedule on receptor occupancy in bone marrow transplantation: analysis with a PBPK-PD model
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Martin Johnson[1], Magdalena Kozielska[1], Venkatesh Pilla Reddy[1], An Vermeulen[2], Rik de Greef[3], Cheryl Li[4], Sarah Grimwood[4], Jing Liu[4], Geny M. M. Groothuis[1], Meindert Danhof[5] and Johannes H. Proost[1] Evaluation of a Mechanism-Based Pharmacokinetic-Pharmacodynamic Model for D2 Receptor Occupancy of Olanzapine in Rats
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A. Taneja(1) , J Nyberg(2) , M Danhof(3) , O Della Pasqua(4) , Pain Project Members of the TI Pharma mechanism-based PKPD modelling platform(5) Optimisation of experimental design for drug screening in behavioural models of pain.
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V.L. Di Iorio(1), R. Clinckers(1,2), I. Smolders(2), Y. Michotte(2), E.C. de Lange(1), M. Danhof(1), R.A. Voskuyl(1), O. Della Pasqua(1) Impact of Seizures and Efflux Mechanisms on the Biophase Kinetics and CNS Effects of Anticonvulsant Drugs
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C. Wang(1),(2), M.Y.M. Peeters(3), K. Allegaert(4), D. Tibboel(2), M. Danhof(1), C.A.J. Knibbe(1),(2),(3) Scaling clearance of propofol from preterm neonates to adults using an allometric model with a bodyweight-dependent maturational exponent
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M.A. Boroujerdi (1), A. Facius (2), M. Danhof (1), O.E. Della Pasqua (1,3) Joint model for dropout in longitudinal trials in COPD patients
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Sebastian Ueckert, Åsa M. Johansson, Elodie L. Plan, Andrew Hooker, Mats O. Karlsson New Estimation Methods in NONMEM 7: Evaluation of Robustness and Runtimes
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N. Frances (1), L. Claret (2), F. Schaedeli Stark (3), R. Bruno (2), A. Iliadis (1) Influence analysis explores heterogeneity in database before data processing by a parametric population method
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H. Marouani (1), L. Claret (2), C. Faivre (1), A. Iliadis (1) Nonparametric Approach using Gaussian Kernels Estimates Multivariate Probability Densities in Population Pharmacokinetics
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Marion Dehez (1), Muriel Boulton (2), Astrid Jullion (2), Bruno Boulanger (2), Ruth Oliver (1), Miren Zamacona (1) Bayesian framework applied to dose escalation studies for biologics
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N. Azzopardi, T. Lecomte, D. Ternant, Piller F, M. Ohresser, H. Watier, E. Gamelin, G. Paintaud Pharmacokinetics and concentration-effect relationship of cetuximab in metastatic colorectal cancer
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P. Kellie Turner(1,3), Johanne Bray(1), David Jamieson(1), Aurélie Petain(2), Antonin Schmitt(2), Michael Cole(1), Etienne Chatelut(2), Alan V. Boddy(1) Cyclophosphamide, Methotrexate, and 5-Fluorouracil Population Pharmacokinetic Models with Pharmacogenetic Covariates
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Sebastian Ueckert, Joakim Nyberg, Andrew C. Hooker Comparison of Different Global Optimal Design Approximations
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Sergey Smirnov (1), Ekaterina Goryacheva (1), Neil Benson (2), Piet Van der Graaf (2), Victoria Flores (3), Oleg Demin (1) Application of systems pharmacology modeling approach to optimize Interferon therapy of hepatitis C
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Metelkin E., Smirnov S., Gizzatkulov N., Demin O. Circulator Is a New Technique for Systems Pharmacology
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A. Lagajolli (1), A. Bertoldo (1), P. Denti (2), C. Cobelli (1) Assessment of the oral glucose minimal model by nonlinear mixed-effects approaches
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J. Grenier(1), JR. Lavigne(1), LE. Pope(2) Population Pharmacokinetic Meta Analysis: Inhibition by Quinidine of the First-Pass and Systemic Metabolism of Dextromethorphan to Dextrorphan
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J. Grenier(1), JR. Lavigne(1), LE. Pope(2) Population Pharmacokinetic and Pharmacodynamic Meta Analysis of Zenvia: Modeling of QT Prolongation
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Paweł Wiczling (1), Michael Rosenzweig (2), Louis Vaickus (2), and William J. Jusko (3) Pharmacokinetics and Pharmacodynamics of Anti-CD3 Monoclonal Antibody, Otelixizumab, in Subjects with Diabetes and Psoriasis
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Anderson JM (1,2,3) Petersson KJ (3) Friberg LE (3) Worek F (4), Thiermann H (4), Buckley NA (1,2). PK modelling of organophosphorus poisoning in humans
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R. Niebecker (1,2), K. Kuester (1), U. Kunz (3), C. Kloft (1) Impact of Different Body Size Descriptors on the Population Pharmacokinetics of a Monoclonal Antibody
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V. Nock (1, 2), A. Lindauer (3), U. Jaehde (3), C. Kloft (1) Leukopenia following high-dose chemotherapy with autologous stem cell retransfusion in patients with testicular cell cancer
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D. Teutonico (1), F. Musuamba (1), H.J. Maas (2), C. van Kesteren (1), A. Facius (3), S. Yang (2), M. Danhof (1), O.E. Della Pasqua (1,2) Development of a template for clinical trial simulations in COPD
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A.Y. Zhang (1), J.M. Skolnik (1, 2), J.S. Barrett (1) Evaluating the Extent of Chemotherapeutic Contamination from Central Venous Catheters in Children with Cancer and Providing Guidance for Accurate Reporting of PK Parameters
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H.T. Thai(1), C. Veyrat-Follet(2), N. Vivier (2), C. Dubruc(2), E. Comets(1), F. Mentré(1) , G. Sanderink(2) A mechanism-based model for the population pharmacokinetics of aflibercept in healthy subjects
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T.P.C. Dorlo(1,2), P.J. de Vries(1), J.H. Beijnen(2) and A.D.R. Huitema(2) Optimal Dosing of Miltefosine in Children and Adults with Leishmaniasis
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Isabelle K. Delattre (1), Flora T. Musuamba (1,2), Joakim Nyberg (3), Roger K. Verbeeck (2), Frédérique Jacobs (4), Pierre E. Wallemacq (1) Population pharmacokinetic modeling and optimal sampling strategy for Bayesian estimation of amikacin in critically ill septic patients
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Bambang Adiwijaya (1), Joshua Henshaw (1), Maria Rosario (1), Holly Kimko (2), Varun Garg (1) Applications of Discrete-Event Dynamic Simulation in HCV Treatment Dynamics
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Hesham S Al-Sallami(1), Michael A Barras(2), Bruce Green(3), Stephen B Duffull(1) A rationale for the routine monitoring of anti-activated factor X (anti-Xa) during enoxaparin treatment
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C. Diack (3), O. Ackaert (3), B. Ploeger (3), P. van der Graaf (1), R. Gurrell (2), M. Ivarsson (2), D. Fairman (1) A true Markov model for sleep disturbance
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Y. Chiu(1), J. Nielsen(2), D. Sarrubi(1), K. Kowalski(2) Population Pharmacokinetics of Lurasidone in Healthy Subjects and Subjects with Schizophrenia
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K. Thelen (1), K. Coboeken (2), S. Willmann (2), J.B. Dressman (1), J. Lippert (2) A novel physiological model to simulate gastrointestinal fluid dynamics, transit of luminal contents, absorption, and pre-systemic metabolism of orally administered drugs in humans
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K. Claaßen (1), S. Willmann (2), K. Thelen (3), K. Coboeken (2), K. Allegaert (4), J. Lippert (2) Physiology-based Simulations of Amikacin Pharmacokinetics in Preterm Neonates
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Simbarashe P. Zvada (1), Jan-Stefan Van Der Walt (1,2), Peter J. Smith (1), P Bernard Fourie (3), Giorgio Roscigno (4), Denis Mitchison (5), Ulrika S.H. Simonsson (2), Helen M. McIlleron (1) Effect of Various Meals on the Population Pharmacokinetics of Rifapentine
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Sabine Pilari and Wilhelm Huisinga Lumping of Physiologically Based Pharmacokinetic Models and a Mechanistic Derivation of Classical Compartmental Models
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R.F.W. De Cock1, M. Danhof1, K. Allegaert2, M. de Hoog3, C.A.J. Knibbe1,3,4 Predicting glomerular filtration rate using clearance of amikacin
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Gordon Graham, Francois, Mercier, Mick Looby Amy Racine Continuous time Markov modelling of relapse sojourns for relapse-remitting multiple sclerosis patients
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Seong Bok Jang(1), Min Soo Park(2), Young Goo Song(3), Kyungsoo Park(1) Population Pharmacokinetics of Amikacin in Korean Clinical Population
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Dalia Khachman (1,2), Jean-Marie Conil (3,4), Bernard Georges (3,4), Sylvie Saivin (2,4), Georges Houin (2) and Celine M. Laffont (1) Population pharmacokinetic analysis of ciprofloxacin in intensive care unit adult patients
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Yoon Jung Lee (1), Sriram Krishnaswami (2), Lutz Harnisch (3), Jonathan French (2), Kyungsoo Park (1) Model-based evaluation of DAS28 as a potential surrogate for ACR20 to establish the dose-response relationship for disease modifying anti-rheumatic drugs. A case study using tasocitinib (CP-690,550), an oral JAK inhibitor.
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Parra-Guillen ZP(1), Hernandez-Alcoceba R(2), Gonzalez-Aseguinolaza G(2), Berraondo P(2), Troconiz IF(1) Nonlinear Pharmacokinetic Model For Interleukin-12 Gene Therapy
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C. Piana(1), K. Adkinson(2), M. Danhof(1), , O.E. Della Pasqua(1,3) Once Daily Pharmacokinetics Of Lamivudine In HIV-Infected Children
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C. Piana(1), M. Danhof(1), O.E. Della Pasqua(1,2) The Influence Of Covariate Distribution On The Prediction And Extrapolation Of Pharmacokinetic Data In Children.
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Martin Fransson(1), Henrik Gréen(2), Jan-Eric Litton(1), Lena E. Friberg(3) Pharmacokinetics of paclitaxel and its metabolites using a mechanism-based model
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Stephan Schmidt (1), Teun Post (2), Massoud Boroujerdi (1), Lambertus A. Peletier (3), Meindert Danhof (1), Oscar Della Pasqua (1, 4) Implication of differences in model parameterisation in osteoporosis
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Marcel PH van den Broek (1), Alwin DR Huitema (2), Floris Groenendaal (3), Antoine CG Egberts (1,4), Carin MA Rademaker (1), Linda S de Vries (3) Optimal dosing of lidocaine for seizure control in preterm and term neonates using population pharmacokinetic modelling and simulation
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Martin Fink (1), Olivier Luttringer (1), Peter Gergely (2), Erik Wallstroem (2), Michael Looby (1), Goonaseelan Pillai (1) Phase I trials: Model-based assessment to identify a clinical relevant change in heart rate
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C. Woloch (1), J. Ciccolini (1), A. Di Paolo(2), A. Iliadis (1) Population Pharmacokinetics of 5FU and its Major Metabolite 5-FDHU in Colorectal Cancer Patients
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A.-K. Frobel, S. Ramusovic, S. Läer Physiologically-Based Pharmacokinetic (PBPK) Modelling of Bisoprolol in Adults and Children and External Model Validation in a Paediatric Clinical Trial
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H. Struemper (1), J. Bauman (2), Z. Jonak (2), S. Murray (2), S. Williams (2), M.J. Robertson (3), J.F. Toso (2) Analysis of Biomarker Responses in Phase I Study of rhIL-18 in Combination with Rituximab in Non-Hodgkin’s Lymphoma to Support Phase 2 Dose Selection
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F. Verga (1) (2), B. You (3), A. Benabdallah (2), F. Hubert (2), C Faivre (1), D. Barbolosi (1) Modeling of the metastatic variability in cancer disease.
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Mary Lor(1), Jean R. Lavigne(1) Modeling and Simulation of Drug X and its Metabolite in Plasma and Urine
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M. Kallenbach (1), J. Hövener (2), G. Kersting (1,2), S. Willmann (3), J. Lippert (3), J. Boos (1), G. Hempel (1,2) Evaluation of a Physiologically-Based Pharmacokinetic (PBPK) Model for the Application of Low Dose Etoposide in Children
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Neil J Attkins(1), Simeon Ramsey(2), Rebecca Fish(2), Piet H. van der Graaf(1) Model based analysis of antagonist binding kinetics at CRF-1 receptors in vitro and in vivo
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H. Eljebari, N. Jebabli, S. Trabelssi, I. Salouage , E. Gaies, M. Lakhal, A. Klouz Effect Of Clonidine On Bupivacaine Clearance In Tunisian Patients: Population Pharmacokinetic Investigation.
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N. Jebabli, I. Salouage, S.Trabelsi, E. Gaïes, H. El jebari, Ch. Belkahia, M. Lakhal, A. Klouz Pharmacokinetic Modelling Of Methotrexate From Routine Clinical Data In Patients With Acute Lymphoblastic Leukemia
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N. Jebabli, H. El jebari, E. Gaïes, I. Salouage, S.Trabelsi, M. Lakhal, A. Klouz Population Pharmacokinetics Of Vancomycin In Tunisian Patients
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Tatiana Karelina(1), Oleg Demin(1), Kirill Zhudenkov(1), Dmitry Svetlichny(1), Oleg Demin Jr(1,3), David Fairman(2), and Balaji Agoram(2) Can systems modeling approach be used to understand complex PK-PD relationships? A case study of 5-lipoxygenase inhibition by zileuton
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J. Guedj (1), C. Bazzoli (2), A.U. Neumann (3), F. Mentre (2) Design Evaluation and Optimization for models of Hepatitis C viral dynamics
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P. Westwood, P. Collier, S. Yakkundi A Pharmacokinetic Study of Ranitidine in a Paediatric Population
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A-01 Wilhelm Huisinga Physiologically-based pharmacokinetic/pharmacodynamic modelling, mathematical model reduction and a mechanistic interpretation of simple empirical models
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A-02 Martin Bergstrand (1), Erik Söderlind (2), Ulf Eriksson (2), Werner Weitschies (3), Mats O. Karlsson (1) Semi-mechanistic modeling of absorption from extended release formulations - linking in vitro to in vivo
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A-03 T. Eissing, J. Lippert, S. Willmann Investigation of the Influence of CYP3A4 Inhibition and Renal Impairment on Morphine and M6G Formation after Codeine Administration using Coupled Whole-Body PBPK Modelling
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A-04 Pascal Chanu (1), Balaji Agoram (2), Rene Bruno (1) Mechanistic Models to Simulate Dose Response of IgE Suppression Following Dosing of Anti-IgE Monoclonal Antibodies
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A-05 Julia Korell, Carolyn V. Coulter, Stephen B. Duffull Design of survival studies for red blood cells
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A-06 Stephen Senn Some considerations concerning covariates in clinical trials
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A-07 Akash Khandelwal, Kajsa Harling, E Niclas Jonsson, Andrew C Hooker, Mats O Karlsson Covariate Model Building Using Linear Approximations
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A-08 Brigitte D. Lacroix(1,2), Lena E. Friberg(1) and Mats O. Karlsson(1) Evaluating the IPPSE method for PKPD analysis
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A-09 Dalia Khachman, Celine M. Laffont and Didier Concordet You have problems to interpret VPC? Try VIPER!
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A-10 B. Boulanger, A. Jullion & P. Lebrun Trial predictions vs. trial simulations in early clinical development: a framework to evaluate the predictive probability of success based on NONMEM outputs
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A-11 Caroline Bazzoli, Sylvie Retout, France Mentré Design evaluation and optimisation in multi-response nonlinear mixed effect models with cost functions: application to the pharmacokinetics of zidovudine and its active metabolite
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A-12 M. Delattre (1), R. Savic (2), R. Miller (3), M. O. Karlsson (4), M. Lavielle (5) Estimation of mixed hidden Markov models with SAEM. Application to daily seizures data.
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A-13 Lay Ahyoung Lim (1), Raymond Miller (2), Kyungsoo Park (1) Dose-Response-Dropout Analysis for Somnolence in Pregabalin-treated Patients with Generalized Anxiety Disorder
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A-14 Chao Zhang1, Paolo Denti1, Jan-Stefan van der Walt1,2, Ulrika SH Simonsson2, Gary Maartens1, Mats O.Karlsson2, Helen McIlleron1 Population Pharmacokinetics of Lopinavir/Ritonavir in Combination with Rifampicin-based Antitubercular Treatment in HIV-infected Children
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A-15 Jeffrey S Barrett1, Sundararajan Vijayakumar2, Kalpana Vijayakumar2, Sarapee Hirankarn1, Bhuvana Jayaraman1, Erin Dombrowsky1, Mahesh Narayan1, Julia Winkler1,3, Marc Gastonguay3 Enhancing Methotrexate Pharmacotherapy in Children with Cancer: A Decision Support System Integrating Real-time PK/PD Modeling and Simulation with Patient Medical Records
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A-16 Sarah C McLeay (1), Glynn A Morrish (1), Carl MJ Kirkpatrick (1) & Bruce Green (2) Exploring different body-size metric based dosing strategies for propofol in morbidly obese versus healthy weight subjects by modelling and simulation approach
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A-17 Eugène Cox (1), D. Russell Wada (1), Nancy Zhang (1) & Frank Wiegand (2) Meta- Analysis of Retention Rates of Post-Marketing Trials to Compare Effectiveness of Second Generation Antiepileptic Drugs
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A-18 Rocío Lledó-García, PhD1, Norman A. Mazer, MD, PhD2 and Mats O. Karlsson, PhD1 A mechanistic model of the steady-state relationship between HbA1c and average glucose levels in a mixed population of healthy volunteers and diabetic subjects
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A-19 Jonathan L. French When and how should I combine patient-level data and literature data in a meta-analysis?
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A-20 Camille Vong, Martin Bergstrand, Mats O. Karlsson Rapid sample size calculations for a defined likelihood ratio test-based power in mixed effects models
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A-21 Lee-Kien Foo, Stephen Duffull D-optimal Adaptive Bridging Studies in Pharmacokinetics
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A-22 Marc Lavielle (1), Hector Mesa (1), Kaelig Chatel (1), An Vermeulen (2) Mixture models and model mixtures with MONOLIX
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A-23 Matthew M. Hutmacher Extending the Latent Variable Model to Non-Independent Longitudinal Dichotomous Response Data
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A-24 Elodie L. Plan, Kristin E. Karlsson, Mats O. Karlsson Analysis Approaches Handling Both Symptomatic Severity and Frequency
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A-25 S. Goutelle (1,2), L. Bourguignon (1,2), R.W. Jelliffe (3), J.E. Conte Jr (4,5), P. Maire (1,2) Mathematical modeling of pulmonary tuberculosis therapy: development of a first prototype model with rifampin
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A-26 A. Russu (1), E. Marostica (1), G. De Nicolao (1), A.C. Hooker (2), I. Poggesi (3), R. Gomeni (3), S. Zamuner (3) Integrated model for clinical response and dropout in depression trials: a state-space approach
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A-27 Petersson KJF (1), Vermeulen AM (2), Friberg LE (1) Predictions of in vivo prolactin levels from in vitro Ki values of D2 receptor antagonists using an agonist-antagonist interaction model.
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A-28 Radojka Savic (1,2), Aurélie Barrail-Tran (3) , Xavier Duval (1,3), Georges Nembot (1,3), Xavière Panhard (1), Diane Descamps (3), Bernard Vrijens (4), France Mentré (1,3), Cécile Goujard (3), Anne-Marie Taburet (3) and the ANRS 134 study group Adherence and Population Pharmacokinetics of Atazanavir in Naïve HIV-Infected Patients using Medication Events Monitoring System (MEMS) for drug intake timing
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S-01 Stephane Vellay, Guillaume Paillard, Eddy Vande Water, Richard Compton Pipeline Pilot - Data Integration, Analysis, and Reporting Platform
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S-02 Jamei M, Feng F, Abduljalil K Simcyp Simulator - a comprehensive platform and database for mechanistic modelling and simulation of drug absorption, tissue distribution, metabolism, transport and elimination in healthy and disease populations using in vitro knowledge
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S-03 Ricardo Paxson SimBiology: A Graphical Environment for Population PK/PD
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S-10 Jürgen B. Bulitta (1), Ayhan Bingölbali (1), Cornelia B. Landersdorfer (1) Development and Evaluation of a New Efficiency Tool (SADAPT-TRAN) for Model Creation, Debugging, Evaluation, and Automated Plotting using Parallelized S-ADAPT, Perl and R
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S-11 Kajsa Harling, Sebastian Ueckert, Andrew C. Hooker, E. Niclas Jonsson and Mats O. Karlsson Xpose and Perl speaks NONMEM (PsN)
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S-12 R Jelliffe, A Schumitzky, D Bayard, R Leary, M Van Guilder, M Neely, S Goutelle, A Bustad, M Khayat, and A Thomson The MM-USCPACK software for nonparametric adaptive grid (NPAG) population PK/PD modeling, and the MM-USCPACK clinical software for individualized drug regimens.
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S-13 Ron J Keizer, JG Coen van Hasselt, Alwin DR Huitema Piraña: Open source modeling environment for NONMEM
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S-14 Marc Lavielle (1), Hector Mesa (1), Kaelig Chatel (1), Benoît Charles (1), Eric Blaudez (1), France Mentré (2) and the Monolix group Analysing population PK/PD data with MONOLIX 3.2
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S-15 Joakim Nyberg, Sebastian Ueckert, Mats O. Karlsson and Andrew C. Hooker PopED - An optimal experimental design software
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