2005 - Pamplona - Spain

2005 - Pamplona - Spain

Thursday June 16
08:00-08:45 Registration and coffee
08:45-08:55 Welcome and Introduction
  Oral session I Lewis Sheiner Student Session chair: Michael Sheiner and Don Stanski
08:55-09:20 Xaviére Panhard Non-linear mixed-effects models for tests of interaction or of lack of interaction in cross-over and parallel pharmacokinetic studies: application to the test of interaction between protease inhibitors and nucleoside analogs in HIV patients
09:20-09:45 Maria Kjellsson A Study Comparing the Performance of the Proportional Odds Model to that of the Differential Drug Effect Model for Cumulative Logits
09:45-10:10 Petra Jauslin-Stetina A Disease Model Describing the Regulation of the Glucose-Insulin System in Diabetic Patients after IVGTT and OGTT
10:10-11:30 Coffee break, Poster and Software session I
  Posters in Group I are accompanied by their presenter (see below)
  Oral session II Oncology session chair: Charlotte Kloft
11:30-11:50 Dinesh de Alwis Resisting population PK, the story of P-gp inhibition and co-administered chemotherapy
11:50-12:10 Sophie Glatt Pre-clinical population PK/PD modelling of a targeted agent for cancer
12:10-12:30 Milly de Jonge Prospective Bayesian pharmacokinetically guided dosing of cyclophosphamide, thiotepa and carboplatin inhigh-dose chemotherapy
12:30-14:00 Lunch
13:00-14:00 Optional 1 hour tutorial 'An overview on how to use NONMEM for PK/PD analyses' given by Nick Holford (link to presentation material)
  Oral session III Methodology session chair: France Mentré
14:00-14:20 France Mentré History and new developments in estimation methods in nonlinear mixed effects models
14:20-14:40 Pascal Girard

A comparison of estimation methods in nonlinear mixed effects models using a blind analysis

14:40-15:00 Chyi-Hung Hsu Analyzing Event History Data with nlme in S
15:00-16:20 Tea break, Poster and Software session II
   Posters in Group II are accompanied by their presenter (see below)
  Oral session IV   chair: Janet Wade
16:20-16:40 Michael Looby An approach to formal decision making in exploratory development
16:40-17:00 Iñaki Trocóniz Application of Pharmacokinetic/Pharmacodynamic Concepts to Modeling in Gene Therapy
17:00-17:30 Planning of future PAGE meetings, preview PAGE 2006
19:00-24:00 Social Evening  
Friday June 17
  Oral session V Model Building Session chair: Mats Karlsson, Philippe Jacqmin and Steve Duffull
09:00-09:05 Mats Karlsson Introduction about and intention of the model building session
09:05-09:30 Aliénor Bergès Do we need a perfect basic structural model before exploring the covariate model? Example with enoxaparin
09:30-09:55 Justin Wilkins Challenges in modelling the pharmacokinetics of isoniazid in South African tuberculosis patients
09:55-10:20 Andrew Hooker Population pharmacokinetic modeling of total and unbound docetaxel plasma concentrations in cancer patients with poor liver function
10:20-11:40 Coffee break, Poster and Software session III
  Posters in Group III are accompanied by their presenter (see below)
  Tutorial   chair: Oscar Della Pasqua
11:40-12:20 Adrian Dunne Tutorial on categorical data analysis
12:20-13:50 Lunch
  Oral session VI   chair: Pascal Girard 
13:50-14:10 Alan Maloney An Application of Modelling and Simulation to Type 2 Diabetes: Development of a general drug-disease model based on a meta analysis of over 40 studies investigating 5 PPAR drugs
14:10-14:30 Anthe Zandvliet A physiologically based population pharmacokinetic model describing the non-linear disposition and blood distribution of indisulam in Caucasian and Japanese patients
14:30-14:50 Lena Friberg Pharmacokinetic-Pharmacodynamic Modelling of QT-Prolongation following Deliberate Self-Poisonings with Citalopram
14:50-16:10 Tea break, Poster and Software session IV
   Posters in Group IV are accompanied by their presenter (see below)
  Oral session VII Model-based drug development chair: Mick Looby 
16:10-16:40 Don Stanski Model-Based Drug Development: A FDA Critical Path Opportunity
16:40-17:00 Wenping Wang Positioning Drug Candidates in a Competitive Landscape - an integrated, data-driven approach
17:00-17:05 Concluding remarks

Posters Thursday Morning (group I)

Applications: Anti-infectives

1. Isabel Gonzalez-Alvarez Pharmacokinetics and bioavailability of new ciprofloxacin derivative (CNV 97101) in rat: repercussion of precipitation in stomach.
2. Déborah Hirt Age-related effects on nelfinavir - M8 pharmacokinetics - A population study in 182 children
3. Xavière Panhard High Inter-Patient Variability of Pharmacokinetics of Lamivudine (LMV), Stavudine (STV) and Zidovudine (ZDV) in HIV-Infected Patients treated with HAART (Cophar 1 – ANRS 102 Study).
4. Maria Rosario Model-based drug development of a new anti-HIV drug
5. María José García Sánchez Vancomycin population pharmacokinetic analysis in patients with hematological malignancies
6. Vincent Jullien Population pharmacokinetics of tenofovir in HIV-infected patients taking highly active antiretroviral therapy.
7. José Moltó Population pharmacokinetics of lopinavir in HIV-infected adults receiving lopinavir/ritonavir
8. Christine Staatz Population pharmacokinetic modelling of gentamicin and vancomycin in patients with unstable renal function following cardiothoracic surgery

Applications: Blood

9. Stephanie Chantel Pharmacokinetics modelling and anti-Xa level simulation of enoxaparin used for venous thromboembolism prophylaxis after orthopaedic surgery
10. Stephanie Chantel Population pharmacokinetics of enoxaparin used for thromboembolism prophylaxis after total hip replacement
11. Bruce Green Use of an indirect effect model to describe the mobilization of progenitor cells induced by AMD3100
12. Anna-Karin Hamberg Pharmacokinetic/Pharmacodynamic Modelling of the Anticoagulant Activity of Warfarin
13. Karl-Heinz Liesenfeld PK/PD-Modeling (PK/PD) and Clinical Trial Simulation (CTS) of Early Clinical Data of a New Oral Direct Thrombin Inhibitor (Dabigatran Etexilate)
14. Juan Jose Perez Ruixo Population Pharmacokinetics of rHuEpo in Healthy volunteers.

Applications: CNS

15. Ekaterina Gibiansky Population PK/PD model of GPI 15715 and GPI-derived propofol in sedation and comparison of PK/PD models for ordered categorical observations
16. Berangere Gruwez A mathematical model for paroxetine antidepressant effect time course and its interaction with pindolol
17. Thorsten Lehr A new CNS active drug and its metabolite: a population pharmacokinetic analysis
18. Lia Liefaard Population Pharmacokinetic/Pharmacodynamic Analysis of Different Subunit Selective GABAergic Ligands in an Animal Model of Epilepsy
19. Gianluca Nucci Population pharmacokinetics of paroxetine in the pediatric population
20. Etienne Pigeolet Retrospective Population Pharmacokinetic Analysis of Levetiracetam in Westerner and Japanese Adults
21. Olivier Petricoul Understanding the variability in clinical response to rufinamide, a new antiepileptic drug: a pooled PKPD analysis
22. Nuria Rivas Population pharmacokinetics of lamotrigine in epileptic patients with data proceeding of therapeutic drug monitoring
23. Gijs Santen Modelling of the Hamilton Depression Rating Scale in Unipolar Depression Trials
24. Brunhild Schiltmeyer Population pharmacokinetics of the new antiepileptic drug lacosamide in healthy subjects with different age and gender
25. Armel Stockis Dose-response analysis of levetiracetam add-on treatment in patients with partial epilepsy
26. Ashley Strougo PK and PK/PD Modelling of CNS Effects and Heart Rate After THC Administration in Humans
27. An Vermeulen Population PK/PD modeling of supine heart rate after oral administration of a new candidate antipsychotic drug
28. Jeffrey Wald Model Based Insights to Lamotrigine for Pain Associated with Diabetic Peripheral Neuropathy

Posters Thursday Afternoon (group II)

Applications: CVS

30. Vincent Duval Ivabradine and S18982 activities on heart rate: a population PK/PD analysis
31. Christine Falcoz Strategies to Improve Model-based Decision-making During Clinical Development
32. Gabriele Fliss Development and evaluation of a population pharmacokinetic model for cilobradine, an If channel blocker
33. Annabelle Lemenuel-Diot Use of Time-to-event analysis to qualify activity of Ivabradine durign exercise tolerance tests
34. Mathilde Marchand The effect of rufinamide concentration on the QT interval in healthy subjects treated during 18 days with multiple ascending doses: a population PKPD analysis.
35. Takahiko Tanigawa A population PK model for nifedipine coat-core tablet
36. Démiana William Faltaos Use of an indirect effect model to describe the LDL Cholesterol lowering process by statins

Applications: Endocrine

37. Josep Maria Cendrós Population pharmacodynamic modelling of lanreotide (Lan) autogel (ATG) in patients with acromegaly
38. Mats Karlsson Pharmacokinetic and pharmacodynamic modelling of the dual PPAR α/γ agonist tesaglitazar in patients with manifestations of insulin resistance
39. Mats Karlsson A pooled population pharmacokinetic analysis of tesaglitazar in patients with type 2 diabetes or with manifestations of insulin resistance
40. Teun Post Treatment Efficacy of Combination-Therapy based on a Mechanistic Characterisation of Disease Processes in Type 2 Diabetes Mellitus over a two-year period
41. Hanna Silber A physiology based model for the glucose-insulin regulation in healthy volunteers and diabetic patients following intravenous glucose provocations.

Applications: Musculoskeletal

42. Maria Garrido Pharmacokinetics and Pharmacodynamics of Rocuronium bromide in patients undergoing brain surgery: Influence of chronic Phenytoin therapy
43. Thorsten Lehr Evaluation of an enterohepatic circulation model: predicting the influence of cholestyramine on the pharmacokinetics of meloxicam
44. Micha Levi Population Pharmacokinetics of Rituximab in RA (Rheumatoid Arthritis) Patients: Combining two phase II studies
45. Christiane Tillmann Meloxicam for juvenile rheumatoid arthritis patients: Is dosing on a mg/kg body weight basis justified?

Applications: Oncology

46. Lorea Bueno Mechanistic PK/PD modelling for signal transduction modulators. Application to TGF-beta RI antagonists.
47. Helena Colom Population pharmacokinetics of high-dose methotrexate in osteosarcoma pediatric patients.
48. Anja Henningsson Population Pharmacokinetic Model for Cremophor EL
49. Markus Joerger Determinants of the pharmacokinetics of methotrexate and its metabolite 7-hydroxy-methotrexate following high-dose infusional methotrexate
50. Angelica Quartino Population Based Pharmacodynamics for In Vitro Drug Sensitivity Assays: Prediction of Model Based Parameters of Drug Activity and Relationship to Clinical Outcome
51. Diane Testart PK-PD model compared with K-PD model to predict haematotoxicity induced by anticancer drugs.
52. Laura Zufía Pharmacokinetics of paclitaxel in liver transplantation cancer patients
53. Laura Zufía Tegafur and 5-Fluorouracil pelvic tissues concentrations in rectal cancer patients treated with preoperative chemoradiation. The processed sample stability investigation and their impact in the reability of data

Applications: Various

54. René Bruno Modelling and Simulation of the Telephone Sexual Activity Daily Diary (TSADD) Data of patients with female sexual arousal disorder (FSAD) treated with sildenafil (Viagra).
55. Xuejun Chen Modeling of circadian effect on lung function in patients with chronic obstructive pulmonary disease
56. John Lukas Pharmacokinetics-guided targeting of mycophenolate mofetil (MMF) in combination renal transplantation treatment confirms the need for dose reduction

Posters Friday Morning (group III)

Methodology: Design

57. Marylore Chenel Optimal blood sampling time windows for parameter estimation using a population approach: design of a Phase II clinical trial
58. Doaa Elsherbiny Population pharmacokinetics of S-mephenytoin and its metabolites S-nirvanol and S-4-hydroxymephenytoin in CYP2C19 poor, intermediate and extensive metabolizers.
59. Ivelina Gueorguieva Population Optimal Design for Multivariate Response Pharmacokinetic Models
60. Andrew Hooker Simultaneous population D-optimal designs for contrast enhanced MRI measurements of atherosclerotic plaque neovasculature.
61. Patrick Johnson Optimising PK sampling under the constraint imposed in later phase clinical trials
62. Kristin Karlsson Randomized exposure-controlled trials; impact of randomization and analysis strategies – from a toxicity perspective
63. Sylvie Retout Relevance of the use of population design evaluation and optimisation methods in the context of drug development projects in Roche
64. Sylvie Retout Designs in nonlinear mixed effects models: application to HIV viral load decrease with evaluation, optimization and determination of the power of the test of a treatment effect
65. Larisa Reyderman Designing Sparse-Sampling Schemes for Population PK Study of a Highly Variable Drug.
66. Oleg Volkov Patients’ Non-compliance with Drug Administration Times and Optimal Population Design in Pharmacokinetics
67. Liping Zhang Analyzing Multi-response Data Using Forcing Functions: illustrated in pharmacokinetic physiological flow modeling

Methodology: General (I)

68. Kristin Carlsson Bioavailability of gabapentin assessed by cumulative urine sampling compared with a model for the saturated absorption of gabapentin.
69. Anne Chain Separating Signal from Noise: PK/PD modelling of QT-interval prolongation
70. S. Y. Amy Cheung Structural identifiability analysis of some semi-physiologically based and whole body physiologically based (WBPBPK) pharmacokinetic models.
71. Shafi Chowdhury Producing NONMEM dataset using a standard SAS® program
72. Emmanuelle Comets Building a pharmacogenetic model to describe the pharmacokinetics of digoxin
73. Valerie Cosson Modelling placebo response in depression using a mechanistic longitudinal model approach
74. Aris Dokoumetzidis Propagation of population PK and PD information using a Bayesian approach: dealing with non-exchangeability
75. Stephen Duffull A Semi-Mechanistic Model For Quantification Of Lean Body Weight
76. Jan Freijer Robust fitting of pharmacokinetic models to Phase II/III clinical trial data
77. Massimiliano Germani Implementation of variability in a physiologically-based pharmacokinetic approach for simulating the first-in-animal study
78. Leonid Gibiansky NMQual: A Tool to Automate Installation and Facilitate Qualification of NONMEM
79. Nick Holford Topical Corticosteroid Bioequivalence – An Evaluation of the FDA Guidance
80. Nick Holford Simultaneous modelling of disease progression and time to event with NONMEM – likelihood ratio test criteria for random and informative dropout models and an evaluation of two methods affecting the quality of parameter estimates
81. Iñaki Trocóniz A New Model to Describe the Bradycardic Effects of If channel blockers in Healthy Volunteers

Posters Friday Afternoon (group IV)

Methodology: General (II)

82. Hannah Jones Prediction of drug-drug interactions and their associated variability in human populations: Application to erlotinib and its coadministration with ketoconazole and rifampicin
83. Thomas Kerbusch The Efficiency of Mixed Effect Modelling to Detect Metabolism-Based Drug-Drug Interactions (mDDI)
84. Andreas Krause Modeling Discontinuation of Treatment in Non-Ignorable Situations
85. Marc Lavielle Estimation of population pharmacokinetic parameters of saquinavir in HIV patients and covariate analysis with MONOLIX
86. Thorsten Lehr Assessment of the potency of a metabolite relative to the parent compound using a population PK/PD model for the inhibition of a neurotransmitter re-uptake transporter in mice
87. Raymond Miller Exposure-Response Analysis Using Time to Event Data: An Example Using Sleep Onset.
88. Elisabet Nielsen A Semi-Mechanistic Pharmacokinetic-Pharmacodynamic Model for Antibiotics
89. Vladimir Piotrovsky Indirect-response model for the analysis of concentration-effect relationships in clinical trials where response variables are scores
90. Jakob Ribbing The Lasso - A Novel Method for Predictive-Covariate Modelling of Population Pharmacokinetics/Pharmacodynamics
91. Adeline Samson Generalisation of the SAEM algorithm to nonlinear mixed effects model defined by differential equations : application to HIV viral dynamic models
92. Walter Schmitt Prediction of Clearance in Children Using a Combined Physiology-based and Enzyme Ontogeny Approach
93. Walter Schmitt Predicting pharmacokinetics in children using PK-Sim®
94. Monica Simeoni Counting events: population approaches using NONMEM
95. Nicolas Simon Cluster analysis : an alternative method for covariate selection in population pharmacokinetics modeling
96. Stacey Tannenbaum A Novel Method for Simulation of Correlated Continuous and Categorical Variables Using A Single Multivariate Distribution
97. Eric Tousset Non-Adherence to Prescribed Therapy is a Major Obstacle for Population PK/PD Studies
98. Tamara van Steeg The influence of an increase in plasma protein binding on the pharmacokinetics and pharmacodynamics of S(-)-Propranolol
99. Justin Wilkins Predicting recovery progression in acute stroke using the Barthel Index
100. Miren Zamacona Modelling time varying kinetics using time dependent feedback control on clearance
101. Stefano Zamuner Use population approach to characterize PK time-course with erratic absorption
102. Per-Henrik Zingmark Modelling a spontaneously reported side-effect by use of a Markov mixed-effects model
103. Klaas Zuideveld Agonist-antagonist interaction models with slope factor: implications of an alternative derivation

Methodology: Model evaluation

104. Karl Brendel Metrics based on objective function for external validation of a population pharmacokinetic model
105. Nick Holford The Visual Predictive Check – Superiority to Standard Diagnostic (Rorschach) Plots