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## Madame Emmanuelle Comets Madame Christine Veyrat-Follet

### Citations

201 |
Bootstrap method: another look at the jacknife. Ann Stat
- Efron
- 1979
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Citation Context ...ved data with replacement to create new datasets having the same size as the original dataset, then fit each bootstrap dataset to construct the distribution of an estimator or a statistic of interest =-=[2,3]-=-. In standard linear regression, the most simple and intuitive method is the case bootstrap which consists of resampling the pairs of observations with replacement. However, other bootstrap methods ex... |

196 |
Tibshirani RJ
- Efron
- 1998
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Citation Context ...s’ interest in the pharmaceutical industry. To date, the best characterized and most highly validated anti-angiogenic approach involves targeting the vascular endothelial growth factor (VEGF) pathway =-=[3]-=-. Vascular endothelial growth factor is the most potent pro-angiogenic growth factor, promoting the formation of blood vessels which are required for both normal and neoplastic tissue growth [1, 4].VE... |

41 | A Singularly Valuable Decomposition: The SVD of a Matrix
- Kalman
- 1996
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Citation Context ...could be considered as pharmacodynamic data information of this drug. Our model development was in agreement with the guidelines of modelling for drugs with TMDD properties as mentioned by Yan et al. =-=[23]-=-. To our knowledge, the model that we developed is the first mechanism-based population pharmacokinetic model for an anti-VEGF drug. In conclusion, the present PK model for aflibercept characterizes w... |

32 |
A procedure for generating bootstrap samples for the validation of nonlinear mixed-effects population models. Comput Methods Programs Biomed 59:19–29.
- Parke, NH, et al.
- 1999
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Citation Context ...in 6.7% papers) and structural model selection (in 3.3% papers). Both nonparametric case bootstrap and parametric bootstrap are implemented in programs, Wings for NONMEM and Pearl-speaks-NONMEM (PsN) =-=[13,14]-=-. While the case bootstrap has been mostly used in population PKPD, there have been very few studies in the literature to evaluate its performance, especially in comparison with the nonparametric/para... |

18 |
Bootstrap Methods and their Application. Cambridge:
- AC, DV
- 1997
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Citation Context ...nase activity of their cytodomains, initiating intracellular signalling.VEGF is expressed in a large variety of malignant tumours, such as tumours of the breast,brain, lung and gastrointestinal tract =-=[5]-=-. Blockade of the VEGF pathway is therefore an effective therapeutic strategy for inhibiting tumour growth [4–6]. Aflibercept (also called VEGF-Trap, Regeneron Pharmaceutics/Sanofi-aventis research) i... |

17 |
Bithell J (2000) Bootstrap confidence intervals: when, which, what? A practical guide for medical statisticians. Stat Med 19:1141–1164
- Carpenter
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Citation Context ...ared with a similar anti-angiogenic agent, bevacizumab, the central volume of distribution was close but the clearance of total aflibercept was nearly four times faster than that of total bevacizumab =-=[20]-=-. From MM parameters, the production rate of VEGF and the irreversible binding constant were calculated to be 0.99 mg day-1 and 2.91 mgml-1 or 19909 pM, respectively. The irreversible binding constant... |

6 |
EN (2005) PsN-Toolkit—a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed 79:241–257
- Lindbom, Pihlgren, et al.
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Citation Context ...flibercept, representing 32.5% of data, were taken into account and used for model development using the extended SAEM algorithm implemented in MONOLIX as an exact maximum likelihood estimationmethod =-=[14]-=-. In this algorithm,the left-censored data are simulated in a right-truncated Gaussian distribution, instead of being imputed by the LOQ value or half of the LOQ value.The data of bound aflibercept co... |

4 |
Chinchilli VM
- EF
- 1997
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Citation Context ...evaluation of the model was based on goodnessof-fit (GOF) plots, including plots of observations vs. individual and population predictions and plots of normalized prediction distribution error (NPDE) =-=[16]-=-. A visual predictive check (VPC) was used to assess model predictive performance, based on the simulation of 500 data sets. Results Data The database for population PK analysis contained data from 56... |

3 |
Marathe VV (1977) Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. J Pharmacokinet Biopharm 5:445–479
- LB, Rosenberg
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Citation Context ... 3,sv er sio ns1s- 9sN ovs2 01 3 Introduction Angiogenesis, the development of new blood vessels from pre-existing vasculature, participates in a variety of physiological processes and disease states =-=[1]-=-. Its critical role in tumour development and progression was established 30 years ago [2]. This discovery brought a new effective approach called anti-angiogenic therapy to cancer treatment, which co... |

3 |
Putter H, Buydens LMC (2000) The bootstrap: a tutorial. Chemom Intell Lab Syst 54:35–52
- Wehrens
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Citation Context ...MDD.sPAGE 19, Abstr 1728 [www.page-meeting.org/?abstract=1728]s34. Kut C, Mac Gabhann F, Popel AS (2007) Where is VEGF in the body? A meta-analysis ofsVEGF distribution in cancer. British J Cancer 97 =-=(7)-=-:978-985s35. Stefanini MO, Wu FT, Mac Gabhann F, Popel AS (2008) A compartment model of VEGFsdistribution in blood, healthy and diseased tissues. BMC Syst Biol 2:77s36. Lu JF, Bruno R, Eppler S, Novot... |

3 |
An approximate likelihood approach to nonlinear mixed effects models via spline approximation. Comput Stat Data Anal 46:747–776
- Ge, Bickel, et al.
- 2004
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Citation Context ...rcerpt 0.05 (9.0) 17.1(3.0) Vp (l) 4.94 (4.0) 27.3 (10) Bound aflibercept – 12.6 (4.0) Q (l day-1) 1.39 (9.0) 49.8 (14) Vt (l) 2.33 (7.0) 39.8 (14) Vb (l) 4.94 (=Vp) – Vmax (mg day-1) 0.99 (5.0) 13.6 =-=(17)-=- Km (mg ml-1) 2.91 (11) 45.6 (15 kint (day-1) 0.028 (5.0) – CL: clearance of free aflibercept from central compartment (CL = kel·Vp). Q: intercompartment clearance of free aflibercept (Q = ktp·Vt = kp... |

2 |
NONMEM User’s Guide-Part i. User Basic Guide
- Beal, LB
- 1989
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Citation Context ...valuated analytically. The likelihood is usually approximated by linearisation of the function f , such as First Order (FO) and First Order Conditional Estimation (FOCE) methods implemented in NONMEM =-=[15]-=-. These methods linearise the structural model either around the expectation of the random effects (FO) or around the individual predictions of the random effects (FOCE). Although the linearisation me... |

2 |
Falandry C, Favier L, Trillet-Lenoir V, Assadourian S, Soussan-Lazard K, Ziti-Ljajic S, Fumoleau P (2012) Phase I dose-escalation study of aflibercept in combination with docetaxel and cisplatin in patients with advanced solid tumours
- Freyer, Isambert, et al.
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Citation Context ... J, Carpenter JR, Kepler MA. Using SAS to conduct nonparametric residual bootstrap multilevel modeling with a small number of groups. Computer Methods and Programs in Biomedicine 2006; 82(2):130–143. =-=[24]-=- Holford NHG, Chan PLS, Nutt JG, Kieburtz K, Shoulson I, Parkinson Study Group. Disease progression and pharmacodynamics in Parkinson disease–evidence for functional protection with levodopa and other... |

2 |
Ozguroglu M, Goksel T, Baldotto C
- Ramlau, Gorbunova, et al.
- 2012
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Citation Context ...valuation of the model was based on goodness-of-fit (GOF) plots, including plots ofsobservations versus individual and population predictions. Plots of normalized predictionsdistribution error (NPDE) =-=[25,26]-=- versus time since last dose (TimeL) were used to assess modelspredictive performance, based on the simulation of 1000 datasets. The NPDE plots with 95%sprediction intervals around the 10th, 50th and ... |

1 |
The Jacknife and Bootstrap Springer.New
- Shao, Tu
- 1995
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Citation Context ... is the case bootstrap which consists of resampling the pairs of observations with replacement. However, other bootstrap methods exist; for example the residual bootstrap and the parametric bootstrap =-=[4,5,6,7]-=-. The residual bootstrap resamples the observed residuals obtained after model fitting then constructs the bootstrap samples. The parametric bootstrap adopts the principle of the residual bootstrap bu... |

1 |
Krishen A
- Das
- 1999
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Citation Context ...th its receptors on endothelial cells. Thesaffinity of aflibercept for VEGF-A (Kd in vitro = 0.5 pM) is higher than that of anti-VEGFsmonoclonal antibodies, such as bevacizumab (Kd in vitro = 500 pM) =-=[8,9]-=-.sPreclinical studies in mice have demonstrated the effects of aflibercept on capillary regression,snarrowing of vessels, blood flow cessation as well as endothelial cell apoptosis [10]. Inhibition of... |

1 |
Nonlinear Mixed-effects Models and Bootstrap resampling: Analysis of Non-normal Repeated
- Halimi
- 2005
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Citation Context ...o account the characteristics of mixed-effects models with two levels of variability (between-subject and residual variability) [8]. Resampling random effects may be coupled with resampling residuals =-=[8,9,10, 11]-=-. The case bootstrap can be combined with the residual bootstrap [6]. In a previous study [12], we conducted a simulation study to evaluate different bootstrap methods that could be used for linear mi... |

1 |
Leeden R, Busing FMTA, Meijer E
- der
- 1997
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Citation Context ...finity to its pharmacologic target such that this interaction is reflected in the pharmacokinetic properties of the drug.A general PKmodel for drugs exhibiting TMDD has been developed by Mager et al. =-=[10, 11]-=-. This model describes the elimination pathway of drug plasma concentrations as the combination of first-order elimination from the central compartment and specific target binding clearance followed b... |

1 |
Zhang JT (2002) The study of long-term hiv dynamics using semi-parametric non-linear mixed-effects models. Stat Med 21:3655–3675
- Wu
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Citation Context ...stems 2000; 54(1):35–52. [10] Ocana J, El Halimi R, Ruiz de Villa MC, Sanchez JA. Bootstrapping repeated measures data in a nonlinear mixed-models context. Mathematics Preprint Series 2005; 367:1–31. =-=[11]-=- Flachaire E. Bootstrapping heteroskedastic regression models: wild bootstrap vs. pairs bootstrap. Computational Statistics and Data Analysis 2005; 49(2):361–376. [12] Halimi R. Nonlinear mixed-effect... |

1 |
Mentre F, Holford NH, Veyrat-Follet C, Comets E (2013) A comparison of bootstrap approaches for estimating uncertainty of parameters in linear mixed-effects models. Pharm Stat. Doi: 10.1002/pst.1561
- HT
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Citation Context ...ugh it is yet unclear which elements should be measured to estimate all the parameters in the full TMDD model. In order to overcome this problem, several simpler forms of the TMDD model were proposed =-=[12, 13]-=-. There are mainly three approximations: quasi equilibrium (QE), quasi steady-state (QSS) and Michaelis–Menten (MM). The QE approximation is based on the assumption that the drug–target binding is muc... |

1 |
Lavielle M, Moulines E
- Delyon
- 1999
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Citation Context ... is reasonable and consistent with the study of Eppler et al. on the development of a TMDD model for recombinant human VEGF (rhVEGF) after i.v. administration in patients with coronary artery disease =-=[18]-=-.VEGF binding to its high affinity receptors was concluded as an essentially irreversible process in vivo.Afliberceptmight have the same properties because this drug is produced from two high affinity... |

1 |
Rasbash J (2003) A novel bootstrap procedure for assessing the relationship between class size and achievement. Appl Statist 52:431–443
- JR, Goldstein
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Citation Context ...s level. This idea of accounting for the difference between the estimated and empirical variance of residuals through an estimate of the shrinkage was proposed in bootstrapping ordinary linear models =-=[21]-=- and was extended for the two levels of variability found in mixed models by Wang et al. [23]. The performance of different bootstrap methods was evaluated under different conditions: the rich design ... |

1 |
MA (2006) Using SAS to conduct nonparametric residual bootstrap multilevel modeling with a small number of groups. Comput Methods Programs Biomed 82:130–143
- Wang, JR, et al.
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Citation Context ...010) Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patientsswith advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGBs80303). J Clin Oncol 28 =-=(22)-=-:3617-3622s41. Rudge JS, Holash J, Hylton D, Russell M, Jiang S, Leidich R, Papadopoulos N, Pyles EA,sTorri A, Wiegand SJ, Thurston G, Stahl N, Yancopoulos GD (2007) VEGF Trap complexsformation measur... |