Jacob Brogren(1) Svante Nyberg(2) Transit Compartment Model Useful for Describing Absorption of Quetiapine XR and IR
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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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Monica Simeoni1, Michael Gold2, Marina Zvartau-Hind3, Michael Irizarry4, Daren Austin1, Roberto Gomeni5 Clinical and Genetic factors affecting Alzheimer’s disease progression in subjects on stable acetylcholinesterase inhibitor therapy: a comparison between mechanistic and empirical disease progression modelling approaches
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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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Gai Ling Li, Don Nichols Towards Quantitative Prediction Of In Vivo Brain Penetration Using A Physiology Based CNS Disposition Model
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Monica Simeoni(1), Michael Gold(2), Marina Zvartau-Hind(3), Michael Irizarry(4), Daren Austin(1), Roberto Gomeni(5) Disease System Analysis: Evaluate the structural properties and the physiological implications of an indirect physiologic response model describing the degenerative progression of Alzheimer’s disease using a closed-form solution
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Karl Brendel, Clare Gaynor, Cyrielle Dumont, Alexia Blesius and Marylore Chenel Using Modelling & Simulation techniques to optimise the design of a paediatric PK/PD study
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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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Sylvain Fouiliard and Marylore Chenel Optimal design and QT-prolongation detection in oncology studies
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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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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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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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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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Fredrik Jonsson (1), Laurent Claret (1), Robert Knight (2), Marta Olesnyskyj (2), Christian Jacques (2), Vincent S. Rajkumar (3), Rene Bruno (1) A Longitudinal Tumor Growth Inhibition Model Based on Serum M-Protein Levels in Patients With Multiple Myeloma Treated by Dexamethasone
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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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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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M.A. Björnsson(1,2), U.S.H. Simonsson(2) Modeling of Pain Intensity Measured on a Visual Analogue Scale and Informative Dropout in a Dental Pain Model after Naproxcinod and Naproxen Administration
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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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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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Aristides Dokoumetzidis, Richard Magin, Panos Macheras Fractional kinetics in multi-compartmental systems
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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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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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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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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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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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Ivelina Gueorguieva1 and Malcolm Rowland2 Is pharmacokinetic variability in microdosing trials comparable to variability following therapeutic doses?
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Michael Heathman (1), Donald Jennings (1), and Bernett Lee (2) Interactive Simulation and Visualization of Drug/Disease Models
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Rik Schoemaker(1), Eric Snoeck(1), Armel Stockis(2) Exposure-response modeling of daily seizure counts in focal epilepsy trials
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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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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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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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Maud Delattre (1), Pierre Del Moral (2), Marc Lavielle (1,3) The SAEM algorithm in MONOLIX for Non-Linear Mixed Effects Models with Stochastic Differential Equations
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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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R. H. Leary Quasi-Monte Carlo EM Methods for NLME Analysis
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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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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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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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Thu Thuy Nguyen (1), Laurent Massias (2), Gilles Defrance (3), Nadège Bourgeois-Nicolaos (3,4), Xavier Duval (5), France Mentré (1), Antoine Andremont (6,7) and the Linezolid study group Population pharmacokinetic of linezolid in inpatients
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M. Kågedal(1), Z. Cseleny(1), S. Nyberg(1), Per Karlsson (2), A Hooker(3), MO Karlsson(3) Estimation of occupancy and radioligand kinetics in the CNS from PET-data in the absence of a reference region.
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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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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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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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M. Petrone (1), S. Beato (2), R. Gomeni (1), F. Gray (3) Integrated approach to overcome a food effect in clinical studies: an example of how in vitro, in vivo and simulation tools can help in determining an appropriate strategy
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Caroline Bazzoli, Anne Dubois, Thu-Thuy Nguyen, France Mentré New features for population design evaluation and optimisation using PFIM3.2: illustration on warfarin pharmacokinetics - pharmacodynamics
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Elke H.J. Krekels (1,2), Saskia van Ham (1), Karel Allegaert (3), Jan de Hoon (4), Dick Tibboel (2), Meindert Danhof (1), Catherijne A.J. Knibbe (1,2,5) Paracetamol pharmacokinetics in term and preterm neonates.
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C. Ambery(1), M. Beerahee(1) Leveraging biomarker exposure-response in drug development
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Justin Wilkins & Michael Looby A comparison of two model-based approaches to investigating covariate effects on the dose-exposure relationship in a Phase III context
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Emilie Hénin, Mats O. Karlsson Semi-physiological modeling of absorption kinetics: application to diclofenac
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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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Anne Chain (1), Dinesh de Alwis(2), An Vermeulen (3), Meindert Danhof (1), Miriam CJM Sturkenboom (4), Oscar Della Pasqua (1, 5) Not-in trial simulation : Prospective use of Not-In-Trial Simulation
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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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O. Lillin-de Vries, R. de Greef, T. Kerbusch Population PK-PD modeling of thorough QT/QTc data allows for mechanistic understanding of observed QTc effects
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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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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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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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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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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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Meg Bennetts Simulation Methodology for Quantitative Study Decision Making in a Dose Response Setting
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I. Matthews (1), E. Pigeolet (1), G. Pillai (1), S. Balser (2), A. Berghout (2), V. Koppenburg (2), U. Kronthaler (2), I. Meyer (2) PKPD Modeling of Dose-Response & Time Course of B-Cell Depletion in Cynomolgus Monkeys
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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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W. Krzyzanski An Interpretation of Transit Compartment Pharmacodynamic Models As Lifespan Based Indirect Response Models.
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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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Xu Steven Xu and Partha Nandy A Casual Graphic Goodness-of-fit Assessment for Markov Pharmacodynamic Models
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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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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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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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Michael R. Dunlavey Derivation of SAEM C-matrix in Phoenix
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Holly Kimko, Donna Skee, Joseph Massarella, Iolanda Cirillo Modeling & Simulation Exercise to Recommend Dosage Regimens for Patients with End-Stage Renal Disease Receiving Hemodialysis
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Tobias Sing, Martin Fink, Michael Looby An R package for industrializing concentration-QT analysis
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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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B Jayaraman, E. Dombrowsky, D. Marsteller, Julia Winkler and J.S. Barrett A SAS-based Solution for NONMEM run management and post-processing
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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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Inès Paule (1), Pascal Girard (1), Michel Tod (1,2) Estimation of Individual Parameters of a Mixed–Effects Dose-Toxicity Model for Ordinal Data
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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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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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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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Toshihiro Wajima, Ryuji Kubota Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling for Integrase Inhibitors with a Simple Viral Dynamic Model
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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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Valerii V. Fedorov, Sergei L. Leonov Optimization of sampling times for PK/PD models: approximation of elemental Fisher information matrix
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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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Radojka Savic (1,6,9), Bruno Fantin (1,2,3), Andremont Antoine (1,2,8), Laurent Massias (7), Xavier Duval (1,4,5,6), France Mentre (1,4,6) Ciprofloxacin Integrated Plasma, Saliva and Sweat Population Pharmacokinetics and Emergence of Resistance in Human Commensal Bacteria
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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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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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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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Michael Neely (1), Michael Reed (2), Roger Jelliffe (1) High-dose amoxicillin pharmacokinetics (PK) and pharmacodynamics (PD) in children
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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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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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Elisabet I. Nielsen (1), Otto Cars (2) Lena E. Friberg (1) Pharmacokinetic-Pharmacodynamic Modelling for Antibiotics: Static and Dynamic In Vitro Time-Kill Curve Experiments
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Florence Hourcade-Potelleret Preliminary Population PK-PD of Dalcetrapib: an Agent Targeting CETP to Raise HDL-C and Prevent Cardiovascular Morbidity and Mortality
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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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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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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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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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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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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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Iñaki F. Trocóniz1, Katja Boland2, Alexander Staab2 Population PK/PD model of the sedative effects of Flibanserin in healthy volunteers
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Metelkin E., Smirnov S., Gizzatkulov N., Demin O. Circulator Is a New Technique for Systems Pharmacology
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J. Bertrand (1), C.M. Laffont (2), E. Comets (1), M. Chenel (3), F. Mentré (1) Genetic effect on a complex parent-metabolite joint PK model developed with NONMEM and MONOLIX
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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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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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C. Navarro(1), C. Fernandez-Teruel(2), I. Gonzalez-Alvarez(3), A. Garcia-Arieta(4), M. Bermejo(3), VG Casabó(1) Bioequivalence trials simulation to select the best analyte for drugs with two metabolic pathways
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Garrido M.J.1, Viudez A.2, Rodríguez J.2, Zárate R.2, Navarro I.3, Romero E.1, García-Foncillas J.2, Trocóniz I.F.1 Population pharmacokinetic modelling of unbound and total plasma concentrations of oxaliplatin administered by hepatic arterial infusion to patients with liver-metastases.
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Sylvie Retout, Valérie Cosson, Nicolas Frey Bayesian modeling of a PK-PD relationship to support an adaptive dose-finding trial
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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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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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C. Steven Ernest II and Andrew C. Hooker Predictor Identification in Time-to-Event Analyses
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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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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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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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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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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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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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Siv Jönsson(2), Alistair Davidse(1), Justin Wilkins(2,3), Jan-Stefan Van der Walt(1,2), Ulrika SH Simonsson(2), Mats O Karlsson(2), Helen McIlleron(1), Peter Smith(1) Population Pharmacokinetics of Ethambutol in South African Tuberculosis Patients
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Paul Matthias Diderichsen (1), Sandeep Dutta (2) A comparison of sequential and joint fitting of pain intensity and dropout hazard in acute pain studies
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Paul Matthias Diderichsen (1), Sandeep Dutta (2) Sufficiently high observation density justifies a sequential modeling approach of PKPD and dropout data
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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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Mahesh N. Samtani (1); Srihari Gopal (1); Jennifer Kern Sliwa (2); J. Thomas Haskins (2); Larry Alphs (2); Kim Stuyckens (3); An Vermeulen (3). Switching to Paliperidone Palmitate[1,2] from Other Depot Antipsychotics: Guidance Based on Pharmacokinetic Simulations
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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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Emmanuelle Comets, France Mentré Using simulations-based metrics to detect model misspecifications
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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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Kristin E. Karlsson (1), Mats O. Karlsson (1) and E. Niclas Jonsson (1)(2) Clinical trial simulations using a stroke disease progression model
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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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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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Henry Pertinez, Leon Aarons Bayesian POP-PK analysis of exposure data from a Phase IIb clinical trial
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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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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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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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Laura Iavarone, Marianna Machin, Marta Neve, Roberto Gomeni, Stefano Zamuner, Italo Poggesi Modeling a time-dependent absorption constant: a trick and some considerations
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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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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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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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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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Thomas Eissing, Michael Block, Katrin Coboeken, Thomas Gaub, Lars Kuepfer, Michaela Meyer, Michael Sevestre, Juri Solodenko, Joerg Lippert Clinical trial simulation with multiscale models: Integrating whole-body physiology, disease biology, and molecular reaction networks
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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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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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Christoph Niederalt(1), Lars Kuepfer(1), Thomas Wendl(1), Stefan Willmann(1), Jörg Lippert(1), Victoria Flores(2) & Piet van der Graaf(2) Mechanistic analysis of fusion proteins: PBPK applied in an Albuferon case study
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Zamuner S. (1), Paronetto M. (1), Moscardo E. (2), Renzulli C. (3), Terron A. (2), Poggesi I. (1) The assessment of convulsion risk: a translational PK/PD modelling approach
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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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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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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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J. Lippert(1), K. Boland(2), S. Willmann(1), E. Hizaler Hoffmann(1), A. Sensse(1), M. Sevestre(1), R. Pyke(3), A. Staab(2) Simulation of the pharmacokinetics of flibanserin under itraconazole co-mediaction with an integrated physiologically-based pharmacokinetic model
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Maria C. Kjellsson(1,4), Veronique Dartois(2), Anne Goh (2), Laura Via(3), Steven Kern(4), Goonaseelan (Colin) Pillai(4) Penetration of Isoniazid, Rifampicin, Pyrazinamide and Moxifloxacin into Pulmonary TB Lesions in Rabbits
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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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Kevin Le Boedec, Celine M. Laffont and Didier Concordet. A new solution to deal with eta-shrinkage: the Weighted EBEs!
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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. 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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Angelica L. Quartino (1), Joakim Nyberg (1), Marie Cullberg (2), Lena E. Friberg (1) Application of Optimal Design to Reduce the Sample Costs of a Dose-finding Study
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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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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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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. 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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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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Joakim Nyberg(1), Robert J. Bauer(2), Andrew C. Hooker(1) Investigations of the weighted residuals in NONMEM 7
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Andrew C. Hooker (1), Elizabeth Dunn-Sims (3), David Fairman (2), Andy Mead (3), Piet Van Der Graaf (2) and Mats O. Karlsson (1) Title: Modeling exposure-response relationships in the rat self-administration model
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Tarjinder Sahota (1), Meindert Danhof (1), Oscar Della-Pasqua (1,2) Model-based safety thresholds for discrete adverse events
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P. Westwood, P. Collier, S. Yakkundi A Pharmacokinetic Study of Ranitidine in a Paediatric Population
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Tarjinder Sahota (1), Nuria Buil (2), Katsutoshi Hara (2), Oscar Della Pasqua (1,2) The Chicken and the Egg in Interoccasion Variability
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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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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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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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Roberto Bizzotto (1), Stefano Zamuner (2), Giuseppe De Nicolao (3), Roberto Gomeni (2), Andrew C Hooker (4), Mats O Karlsson (4) Multinomial logistic functions in Markov-chain models for modeling sleep architecture: external validation and covariate analysis
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Mezzalana E (1), Bizzotto R (1), Sparacino G (1), Zamuner S (2) Multinomial logistic functions in Markov-chain models for modeling sleep architecture: internal validation based on VPCs
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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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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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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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Chao Chen Test Of Concept By Simulation: Comparing Response-Rate Findings Between Parallel And Titration Designs
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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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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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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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Thaddeus H. Grasela* (1), Jill Fiedler-Kelly (1), Darcy J. Hitchcock (1), Elizabeth A. Ludwig (1), Julie A. Passarell (1) Forensic Pharmacometrics: Part 1 - Data Assembly
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Thaddeus H. Grasela* (1), Jill Fiedler-Kelly (1), Elizabeth A. Ludwig (1), Julie A. Passarell (1), Darcy J. Hitchcock (1) Forensic Pharmacometrics: Part 2 - Deliverables for Regulatory Submission
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Anders Viberg (1), John Martino (2), Etienne Lessard (2) and Jennifer Laird (2) Using an Innovative Design in Behavioural Pharmacology Studies Saves Money and Animal Lives
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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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Jeroen Elassaiss-Schaap Allometric scaling in oncology disease progression from xenograft tumor growth to human non-small-cell lung cancer
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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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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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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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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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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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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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Paul G Baverel, Kristin E Karlsson, Mats O Karlsson Informativeness of Internal and External Validation Techniques in Various Simulation Settings
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J.B. Bulitta (1, 3), J. Li (2), A. Poudyal (2), H.H. Yu (2), R.J. Owen (2), B.T. Tsuji (3), R.L. Nation (2), A. Forrest (1, 3) Mechanism-based Modelling of the Synergy of Colistin Combinations against Multidrug-Resistant Gram Negative Bacteria
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Sebastian Ueckert, Joakim Nyberg, Andrew C. Hooker Comparison of Different Global Optimal Design Approximations
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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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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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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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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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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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Sabine Pilari and Wilhelm Huisinga Lumping of Physiologically Based Pharmacokinetic Models and a Mechanistic Derivation of Classical Compartmental Models
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Nils Hoem (1), Kristin C. Carlsson A population PK model of EPA and DHA after intake in phospholipid as well as in triglyceride form.
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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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Bizzotto R (1), Zamuner S (2) PK-PD modeling of Wake after Sleep Onset time-course
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SeungHwan Lee, MD, Bo-Hyung Kim, MD, Donghoon Shin, MD, Min Kyu Park, MD, Sang-Goo Shin, MD, PhD, Kyung-Sang Yu, MD, PhD, In-Jin Jang, MD, PhD A population analysis of Intravenous Dexmedetomidine in Korean
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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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R Jelliffe(1), M Neely(1), V Ozdemir(2) Pharmacogenomics and Individualized Dosage Regimens
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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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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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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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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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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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