Abstracts - PAGE Meeting (Population Approach Group Europe)

Abstracts (70)

An Vermeulen Ph.D., Vladimir Piotrovsky Ph.D.

Modeling the longitudinal concentration-response data after i.m. administration of Risperdal CONSTATM in psychotic patients of different phenotypes

Sandra A.G. Visser(1), Susanna Pozarek(1), Tomas Forsberg(2), Johan Gabrielsson(1).

Modelling of the tolerance, rebound and carry-over phenomena observed in clomethiazole-induced hypothermic effects in rats.

Karin Tunblad, Margareta Hammarlund-Udenaes and Niclas Jonsson

An integrated model for data from a microdialysis experiment

Xuejun Chen, Suresh Mallikaarjun, Steven L. Bramer

Comparison of different approaches for the analysis of drug exhibiting nonlinearity of Cmax to increasing doses

Kristin Cecilie Carlsson(1), Heidi Hansen(1), Roger Jelliffe(2), Nils Ove Hoem(3).

Establishing a tool for individualised dosing of gabapentin – The use of a non-parametric population kinetics model in the MM-USCPACK software, a new tool for clinical dosage optimization.

A. Lemenuel-Diot(1), N.frey(2), C. Laveille(2), R. Jochemsen(2), A. Mallet(1)

Comparison between Gauss Hermite quadrature and NONMEM on the ability to detect subpopulations

Daren J Austin and Ann Allen

Meta analysis and clinical trial simulation in drug development.

Kristin Karlsson, Mats O. Karlsson, Anders Grahnén and E. Niclas Jonsson

Randomized dose ranging trials; assessment of statistical power for various design and analysis strategies

Vladimir Piotrovsky

Population PK-PD analysis of cardiovascular effects of non-cardiovascular drugs with the emphasis on QT prolongation

Stefano Zamuner and Roberto Gomeni

Impact of slow receptor binding kinetics and change in Cerebral Blood Flow in receptor occupancy estimation with PET experiments. A simulation study

T. Waterhouse (1), J. Eccleston (1), S. Duffull (2)

Optimal Designs For Parameter Estimation And Model Discrimination

Robert Leary [1], Roger Jelliffe [2], Alan Schumitzky[2], Michael Van Guilder [2]

Improved Computational Methods for Statistically Consistent and Efficient PK/PD Population Analysis

Nerea Leal(1), Monica Rodriguez(1), Rosario Calvo(1), Fatima Agrad(1), Leire de la Fuente(2), Elena Suarez(1), John C Lukas(3)

Altered effect and pharmacokinetics of propofol in rats with experimental diabetes mellitus

Monica Rodriguez(1), Nerea Leal(1), Rosario Calvo(1), Elena Suarez(1), Ignacio Ortega(1), John C Lukas(2)

Influence of high levels of alpha-1-acid glycoprotein in the pharmacokinetics and the analgesic effect of methadone in the rat: A population approach

Ekaterina Gibiansky (1), Michel MRF Struys (2), Leonid Gibiansky (3)

Bispectral Index of AQUAVAN™-Derived Propofol: Population PK/PD Modeling and Application to an Effect – Controlled Trial

Leonid Gibiansky (1), Michel MRF Struys (2), Ekaterina Gibiansky (3)

Simultaneous Population Pharmacokinetic Model of AQUAVAN™ And AQUAVAN™-Derived Propofol

P. Magni(1), R. Bellazzi (1), G. De Nicolao(1), M. Simeoni(1), M. Germani(2), I. Poggesi(2), M. Rocchetti (2)

A Bayesian approach to non-parametric AUC estimation in population studies

M. Simeoni(1), F. Fiorentini (2), M. Germani(2), I. Poggesi(2), M. Rocchetti (2)

Application of population approaches in pharmaco-toxicological studies

L. Labbé (1), S.M. Hammer (2), J.W. Mellors (3), S. Rosenkranz (4), L.B. Sheiner (1), and the ACTG 398 study team

A Markov Model For The Effect Of Covariates Including Drug Adherence On Longitudinal Viral Response In HIV Patients

P. Girard, L. Claret, W. Ebling and S.T. Forgue, M. Heathman, A. Ghosh, C.T. Benson

Evaluation Of An Osteoporosis Biomarker Model For Simulation Using Posterior Predictive Check Technique

Eugène Cox (1), Henrik Agerso (2), Thomas Senderovitz(2).

A Population Pharmacokinetic-Pharmacodynamic Model For Count Data: Application to the Effect of Atosiban on Uterine Activity in Preterm Labor Patients

MJ. Garrido(1), JM. Cendrós(2), IF. Trocóniz(1), C. Segura(1), C. Peraire(2), R. Obach(2)

Population pharmacokinetic/pharmacodynamic modelling of the haematological effects of the new anticancer drug diflomotecan: A combined analysis from the first two phase I studies

A.C. Hooker, M. Dodds, and P. Vicini

Simultaneous Population D-Optimal Designs of Pharmacokinetic-Pharmacodynamic Experiments

Sandström M (1), Lindman H (2) , Nygren P (2), and Karlsson MO (1)

Population Analysis of the Pharmacokinetics and the Haematological Toxicity of the Fluorouracil-Epirubicin-Cyclophosphamide Regimen in Breast Cancer Patients

Sy SK(1,2,3), Pieniaszek HJ(3,4), Kornhauser DM(3), Davidson AF(3), Jiao Q(3), Cain V(3,5), Martin DE(3,6)

Pharmacodynamic drug interaction of roxifiban during CYP induction and inhibition

Sunny Chapel, PhD, Jeffrey S. Barrett, PhD, Marc Pfister, MD

Modeling & Simulation Approach to Discriminate True Food Effects: Comparison with Standard Noncompartmental Methods

Delphine Martin, Roeline Jochemsen , Christian Laveille and Nicolas Frey

Combined-PK-Analysis of a new compound exhibiting highly variable plasma profiles due to first pass metabolism

Sophie Callies 2, Dinesh P de Alwis 1, Michael Burgess 1, and Leon Aarons 2

Pharmacokinetics of Daunorubicin and its metabolite Daunorubicinol in the absence and presence of a potent P-gp inhibitor, Zosuquidar.3HCl (LY335979).

Dymphy Huntjens, Magret Blom-Roosemalen, David Spalding, Meindert Danhof and Oscar Della Pasqua

Modelling of biomarker response of naproxen in rats and humans

Zamacona MK, Gomeni R

Influence of study design and interindividual variability on In Vitro – In Vivo Correlation evaluation

B Mc Hugh (1), R Gieschke (1), M Karlsson (2)

Population Pharmacodynamic Analysis of Glucose and Insulin levels Evaluated with a Hot Glucose Minimal Model, a Total Glucose Minimal Model, and an Insulin Minimal Model

J Aluri, B Zussman, J Sidhu, B Patel and D Boyle

Cilomilast (Ariflo): Population pharmacokinetic modeling and validation in COPD patients.

Sabrina Salhi and Roberto Gomeni

Population Whole Body Physiologically based Pharmacokinetic/Pharmacodynamic modelling in drug development: Impact of input parameters variability and incertainty on pharmacodynamic response

Ulrika S.H. Simonsson, Thomas Senderovitz and Mats O. Karlsson

Population PK/PD Modeling of Testosterone (T), LH and Dihydrotestosterone (DHT) Response to Single SC Degarelix in Male Volunteers

A. Bertoldo, G. Sparacino, C. Cobelli

Population approaches for quantitative PET imaging

Xavière Panhard, France Mentré

Evaluation by simulation of tests based on non-linear mixed-effects models in interaction and bioequivalence cross-over trials

Nguyen T. X. Q.(1), Munafo A. (1), Goggin T. (1)

Population pharmacokinetic modelling of Emfilermin in healthy postmenopausal women and in women undergoing Embryo Tranfer (ET)

C. Le Guellec, F. Odoul, A. Henrot, G. Paintaud, E. Saliba, M.-C. Saux, E. Autret-Leca

Population pharmacokinetics of cisapride in preterm and term neonates

Jakob Ribbing and Niclas Jonsson

Power, Selection Bias And Predictive Performance Of The Population Pharmacokinetic Covariate Model

Lorraine D. Ralph1,2, Alison H. Thomson1,3, Nicola A. Dobbs4, Chris Twelves5

Bayesian Estimation of Epirubicin Clearance by Limited Sampling

T. Funaki(1), Y. Gao(2), R. Wada(2), K. Nakai(1), K. Miura(1), H. Kinoshita(1)

Computer-Assisted Trial Design (CATD) for PEG-IFN with Using PD Marker to Predict Efficacy

Philip J. Lowe (1) and William Sallas (2)

Probabilistic Risk Assessment Using Integrated Preclinical-Clinical PK/PD Modelling in NONMEM

Hussain Mulla, Suneel Pooboni, David Jenkins, Graham Lawson, Richard Firmin, David Upton

Population Pharmacokinetics of Vancomycin during Extra Corporeal Membrane Oxygenation (ECMO)

Jan Freijer, Teun Post, Bart Ploeger, Joost DeJongh, Meindert Danhof

Modelling of drug absorption as a transport-limited process

C.Tillmann, I.F. Trocóniz (#), J. Stangier, K. H. Liesenfeld, H.G. Schaefer

Population pharmacokinetic analysis of the new oral thrombin inhibitor dabigatran etexilate (BIBR1048) in patients undergoing primary elective total hip replacement surgery.

Nicholas H.G. Holford 1, Jogarao V.S. Gobburu,2 Diane R. Mould 3

Implications of Including and Excluding Correlation of Random Effects in Hierarchical Mixed Effects Pharmacokinetic Models

A.Blesius (1), S. Chabaud (1), M. Cucherat (1), P. Mismetti (2), JP. Boissel (1), P.Nony (1).

Potential consequences of drug non-compliance on the therapeutic / iatrogenic effects of oral anticoagulant therapy : an in silico study.

C. Jamois(1,2,3), E. Comets(3), L. Bonhomme-Faivre(1,2) and F. Mentré(3).

Pharmacokinetic analysis of paclitaxel administered per os in Swiss mice after a pre-treatment with recombinant interleukin-2 (rIL2).

K. Brendel(1), M. Legrand(2), A.M. Taburet(3), G. Baron(1), C. Goujard(4), F. Mentré(1) and the Cophar-1 study group.

Population pharmacokinetic analysis of indinavir in HIV-patients treated with a stable antiretroviral therapy

Hugo Maas, Oscar Della Pasqua, Meindert Danhof

A hidden markov model for characterizing the anti-migraine action of triptans

Andreas Groth & Mikael Thomsen

Markedly different predictions about insulin PharmacoDynamic (PD) measurement feasibility in healthy subjects from recently proposed IntraVenousGlucoseToleranceTest (IVGTT)-based insulin-glucose models

Gianluca Nucci and Roberto Gomeni

Comparison of alternative models for the analysis of drug disposition profiles showing enterohepatic circulation using a population approach

A. Rousseau, F. Saint-Marcoux, J. Debord, P. Marquet.

Pharmacokinetics of cyclosporine in lung transplant patients with and without cystic fibrosis. A NONMEM analysis.

Christoffer W. Tornøe(1), Henrik Agersø(1), E. Niclas Jonsson(2), Henrik Madsen(3), and Henrik A. Nielsen(3)

Non-Linear Mixed-Effects Models in NLME with Differential Equations

Y. Merlé (1,2), J.M. Tréluyer (2,3), E. Rey (3), J. Dimet (3), G. Leleu (4), S. Blanche (5).

Nonparametric population analysis of stavudine pharmacokinetic data in neonates, infants, children and adults

Y Bourhis (1), A Iliadis (2), C Lucas (3), AB Depouilly (3), C Laveille (3), B Tranchand (1)

Population Pharmacokinetic Study of Fotemustine

Gudrun Würthwein (1), Georg Hempel (2), Felice C. Adler-Shohet (3), Jay M. Lieberman (3), Thomas J. Walsh (4), and Andreas H. Groll (2)

Population Pharmacokinetics of Amphotericin B Lipid Complex in Neonates

Robert Bies (1,2), Mark E. Sale (3), Bruce G. Pollock (1,2)

Comparing binary tree and automated machine learning covariate search strategies

K.Ogungbenro and L. Aarons

Sample Size Calculation based on Confidence interval for Pharmacokinetic Studies

In-Sun Nam and Leon Aarons

Multiple Imputation of Serum Creatinine

S. Gisbert, I. Gueorguieva, L. Aarons and M. Rowland

Incorporating Variability in WBPBPK Models: Application to Three Benzodiazepines with Extrapolation from Rat to Man

I. Gueorguieva, L. Aarons, T. Rodgers and M. Rowland

D-Optimal Design for Multivariate Response: Prospective Planning of a Beta-blocker Study in Rat Involving Cassette Dosing

Pascal Chanu (1), Audrey Janoly-Dumenil (2), Nathalie Bleyzac (2), Jacques Bourgeois (3), Brigitte Tranchand (1)

Pharmacokinetic model for vancomycin performed with sparse data on neonates

Milly E de Jonge(1), Alwin DR Huitema(1), Sjoerd Rodenhuis(2) and Jos H Beijnen(1).

Integrated population pharmacokinetic model of both cyclophosphamide and thiotepa suggesting a mutual drug-drug interaction.

Daniël M. Jonker (1,2), Rob A. Voskuyl (1,2) and Meindert Danhof (1)

Population pharmacodynamic analysis of the anticonvulsant effects of tiagabine and lamotrigine in combination

Bruce Green(1), John Atherton(2), Justin Westhuyzen(2),Leeanne Kluver(2),David Saltisi(2)

Development of a dosing strategy for enoxaparin in patients with renal impairment using a population pharmacokinetic approach

Sophie Glatt, Mauro Buraglio, Eliane Fuseau

Population Pharmacokinetics of onercept in healthy subjects.

D.M. Reith (1), W. Hooper (2), M Franklin (2).

Comparison of NONMEM with the Two-Stage approach for obtaining population means of the pharmacokinetic parameters of fluoxetine

C. Garnett (1), K.H. Liesenfeld(2), C. Tillmann(2), I. Troconiz(3), H.G. Schaefer(2), J. Stangier(2), H. Lee (1)

Clinical Trial Simulation of the Dose-Response Relationship of a Direct Thrombin Inhibitor, Dabigatran Etexilate, in Hip Replacement Patients

K.H. Liesenfeld, C. Tillmann, I. Troconiz (#), H.G. Schaefer, J. Stangier

Population pharmacodynamic analysis of dabigatran, the active form of the new oral direct thrombin inhibitor dabigatran etexilate (BIBR 1048), on the prolongation of aPTT and ECT in orthopaedic patients.