Výsledky vyhledávání - "Karl Brendel"

Akademický článek

Population pharmacokinetics of liposomal irinotecan in patients with cancer and exposure–safety analyses in patients with metastatic pancreatic cancer

Autor: Karl Brendel, Tanios Bekaii‐Saab, Patrick M Boland, Farshid Dayyani, Andrew Dean, Teresa Macarulla, Fiona Maxwell, Kabir Mody, Anna Pedret‐Dunn, Zev A Wainberg, Bin Zhang

Publikováno v: CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 12, Pp 1550-1563 (2021)

Abstract Liposomal irinotecan is a liposomal formulation of irinotecan, which prolongs circulation of irinotecan and its active metabolite SN‐38. A population pharmacokinetic (PK) model was developed based on data from seven studies (N = 440). Adeq

Externí odkaz: https://doaj.org/article/e00fe99ece8b44b19ef2e7b6979ee045

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Development and performance of npde for the evaluation of time-to-event models

Autor: Emmanuelle Comets, Marc Lavielle, Marc Cerou, Marylore Chenel, Karl Brendel

Publikováno v: Pharmaceutical Research
Pharmaceutical Research, 2018, 35 (2), pp.30. ⟨10.1007/s11095-017-2291-3⟩
Pharmaceutical Research, American Association of Pharmaceutical Scientists, 2018, 35 (2), pp.30. 〈10.1007/s11095-017-2291-3〉
Pharmaceutical Research, American Association of Pharmaceutical Scientists, 2018, 35 (2), pp.30. ⟨10.1007/s11095-017-2291-3⟩

International audience; Purpose - Normalised prediction distribution errors (npde) are used to graphically and statistically evaluate mixed-effect models for continuous responses. In this study, our aim was to extend npde to time-to-event (TTE) model

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0e6d477ca183022145d302d52d49292e
https://www.hal.inserm.fr/inserm-01695500v2

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Model-based approaches for ivabradine development in paediatric population, part I: study preparation assessment

Autor: Charlotte Gesson, Sylvain Fouliard, Marylore Chenel, François Bouzom, Sophie Peigné, Karl Brendel

Publikováno v: Journal of Pharmacokinetics and Pharmacodynamics. 43:13-27

The main objective was to help design a paediatric study for ivabradine, a compound already marketed in adults, focusing on: the paediatric formulation evaluation, the doses to be administered, the sampling design and the sampling technique. A second

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a0158a8c04081a40b334ea5549bbfdc2
https://doi.org/10.1007/s10928-015-9451-z

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First-in-human phase I study of oral S49076, a unique MET/AXL/FGFR inhibitor, in advanced solid tumours

Autor: V. Cattan, Sophie Postel-Vinay, Analia Azaro, Jordi Rodon, Jean-Charles Soria, Karl Brendel, Antoine Hollebecque, Lucie Marfai, Audrey Delmas, Stéphanie Malasse, Isabelle Sudey, Paolo Nuciforo

Publikováno v: European journal of cancer (Oxford, England : 1990). 81

Background and objectives S49076 is a novel ATP-competitive tyrosine kinase inhibitor of MET, AXL and FGFR with a unique selectivity profile. A phase I open-label study was undertaken to establish the tolerability profile and determine the recommende

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d77ec45b2b925a7a27ea150bab3c1677
https://pubmed.ncbi.nlm.nih.gov/28624695

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Metrics for External Model Evaluation with an Application to the Population Pharmacokinetics of Gliclazide

Autor: Karl Brendel, Emmanuelle Comets, Céline Laffont, Christian Laveille, France Mentré

Publikováno v: Pharmaceutical Research
Pharmaceutical Research, American Association of Pharmaceutical Scientists, 2006, 23 (9), pp.2036-49. ⟨10.1007/s11095-006-9067-5⟩

International audience; PURPOSE: The aim of this study is to define and illustrate metrics for the external evaluation of a population model. MATERIALS AND METHODS: In this paper, several types of metrics are defined: based on observations (standardi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b564c673e946569c81a6f3c3ec53f762
https://doi.org/10.1007/s11095-006-9067-5

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Absence of association between MDR1 genetic polymorphisms, indinavir pharmacokinetics and response to highly active antiretroviral therapy

Autor: Céline Verstuyft, Fabienne Marcellin, Laurence Morand-Joubert, Odile Launay, Karl Brendel, France Mentré, Gilles Peytavin, Laurence Gérard, Laurent Becquemont, Jean Pierre Aboulker

Publikováno v: AIDS. 19:2127-2131

Objective: The relationship between MDR1 single nucleotide polymorphisms (SNP) and the pharmacokinetic or pharmacodynamic responses to protease inhibitors has been recently challenged. Aim: The objective of the present study was to determine whether

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::169c9dc41eec67b3a53e67c100e8733a
https://doi.org/10.1097/01.aids.0000196122.91633.04

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

Autor: Karl, Brendel, Mayeule, Legrand, Anne-Marie, Taburet, Gabriel, Baron, Cécile, Goujard, France, Mentré

Publikováno v: Fundamental and Clinical Pharmacology. 19:373-383

The objectives of this study were to build a population pharmacokinetic model that describe plasma concentrations of indinavir in human immunodeficiency virus (HIV)-infected patients with sustained virological response under a stable antiretroviral c

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c2a1f568a6bec63e8b2d45fedae4b5dc
https://doi.org/10.1111/j.1472-8206.2005.00315.x

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Sampling designs for xerophthalmia prevalence surveys

Autor: Joanne Katz, Keith P. West, Karl Brendel, Steven S. Yoon

Publikováno v: International Journal of Epidemiology. 26:1041-1048

Background. The purpose of this study was to estimate the bias and design effects associated with the Expanded Program on Immunization's (EPI) sampling design when estimating xerophthalmia prevalence, and to estimate the savings associated with EPI i

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f1b995d9a87ba699afca9e44cf553d57
https://doi.org/10.1093/ije/26.5.1041

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Optimal sampling times for a drug and its metabolite using SIMCYP(®) simulations as prior information

Autor: Cyrielle Dumont, France Mentré, Clare Gaynor, Karl Brendel, Charlotte Gesson, Marylore Chenel

Publikováno v: Clinical Pharmacokinetics
Clinical Pharmacokinetics, Springer Verlag, 2013, 52 (1), pp.43-57. ⟨10.1007/s40262-012-0022-9⟩

International audience; BACKGROUND: Since 2007, it is mandatory for the pharmaceutical companies to submit a Paediatric Investigation Plan to the Paediatric Committee at the European Medicines Agency for any drug in development in adults, and it ofte

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::42983c0defcb18a27811282d77d27919
https://pubmed.ncbi.nlm.nih.gov/23212609

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Why should prediction discrepancies be renamed standardized visual predictive check?

Autor: Emmanuelle Comets, Karl Brendel, France Mentré

Publikováno v: Journal of Clinical Pharmacology
Journal of Clinical Pharmacology, Wiley, 2012, 52 (8), pp.1284-5. ⟨10.1177/0091270011412963⟩

We have read the paper by Wang and Zhang[1]. We are pleased to see that other authors further illustrate and also find nice properties for an evaluation tool that we first used more than ten years ago[2], presented at PAGE in 20003 and published exte

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fafe2c256225b1c35032ff50a9b11f06
https://pubmed.ncbi.nlm.nih.gov/21257797

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