Publications by authors named "Bernard Sebastien"

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Innovations and Best Practices for Therapeutic Development in Pediatric Rare Diseases: A Model-Informed Drug Development Perspective.
Rajesh Krishna, Satyendra Suryawanshi, Juliane Rascher, Sonja Hartmann, Bernard Sebastien

Clin Pharmacol Ther· December 2025

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Sharp Bounds for Continuous-Valued Treatment Effects with Unobserved Confounders.
Jean-Baptiste Baitairian, Bernard Sebastien, Rana Jreich, Sandrine Katsahian, Agathe Guilloux

Biom J· October 2025

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Pediatric Rare Diseases Development in the Pharmaceutical Industry: An International Consortium for Innovation and Quality in Pharmaceutical Development, Clinical Pharmacology Leadership Group-Pediatrics Working Group, Rare Diseases Subteam Whitepaper Examining the Current Landscape and Recommendations for the Future.
Rajesh Krishna, Bernard Sebastien, Solange Corriol-Rohou, S Y Amy Cheung, Jing Liu

Clin Pharmacol Ther· December 2024

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Randomized Phase III Study of Amcenestrant Plus Palbociclib Versus Letrozole Plus Palbociclib in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Primary Results From AMEERA-5.
Javier Cortés, Sara A Hurvitz, Joyce O'Shaughnessy, Suzette Delaloge, Hiroji Iwata, Bernard Sebastien

J Clin Oncol· August 2024

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Empirical bayes approach for dynamic bayesian borrowing for clinical trials in rare diseases.
Bernard Sebastien

J Pharmacokinet Pharmacodyn· December 2023

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Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials.
Bernard Sebastien, S Y Amy Cheung, Solange Corriol-Rohou, Margaret Gamalo-Siebers, Rana Jreich

J Biopharm Stat· November 2023

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An Overview of Current Methods for Real-world Applications to Generalize or Transport Clinical Trial Findings to Target Populations of Interest.
Albee Y Ling, Maria E Montez-Rath, Paulo Carita, Karen J Chandross, Laurence Lucats, Bernard Sebastien

Epidemiology· September 2023

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Development and validation of a predictive model to guide the use of plerixafor in pediatric population.
Bernard Sebastien, Peter Cheverton, Catherine Magnin, Jihane Aouni, Remi Castan

Bone Marrow Transplant· December 2022

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Exposure-response analyses for selection/confirmation of optimal isatuximab dosing regimen in combination with pomalidomide/dexamethasone treatment in patients with multiple myeloma.
Fatiha Rachedi, Kimiko Koiwai, Nadia Gaudel-Dedieu, Bernard Sebastien, Hoai-Thu Thai

CPT Pharmacometrics Syst Pharmacol· June 2022

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Joint modelling and simulation of M-protein dynamics and progression-free survival for alternative isatuximab dosing with pomalidomide/dexamethasone.
Hoai-Thu Thai, Nadia Gaudel, Marc Cerou, Geraldine Ayral, Jean-Baptiste Fau, Bernard Sebastien

Br J Clin Pharmacol· May 2022

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Comparison of statistical methodologies used to estimate the treatment effect on time-to-event outcomes in observational studies.
Rana Jreich, Bernard Sebastien

J Biopharm Stat· July 2021

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Matching-adjusted indirect comparisons: Application to time-to-event data.
Jihane Aouni, Nadia Gaudel-Dedieu, Bernard Sebastien

Stat Med· February 2021

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Design optimization for dose-finding trials: a review.
Jihane Aouni, Jean Noel Bacro, Gwladys Toulemonde, Pierre Colin, Loic Darchy, Bernard Sebastien

J Biopharm Stat· July 2020

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Evaluation of non-linear-mixed-effect modeling to reduce the sample sizes of pediatric trials in type 2 diabetes mellitus.
Clémence Rigaux, Bernard Sébastien

J Pharmacokinet Pharmacodyn· February 2020

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Cardiac risk assessment based on early Phase I data and PK-QTc analysis is concordant with the outcome of thorough QTc trials: an assessment based on eleven drug candidates.
Puneet Gaitonde, Yeamin Huh, Borje Darpo, Georg Ferber, Günter Heimann, Bernard Sebastien

J Pharmacokinet Pharmacodyn· December 2019

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Nonlinear joint models for individual dynamic prediction of risk of death using Hamiltonian Monte Carlo: application to metastatic prostate cancer.
Solène Desmée, France Mentré, Christine Veyrat-Follet, Bernard Sébastien, Jérémie Guedj

BMC Med Res Methodol· July 2017

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Using the SAEM algorithm for mechanistic joint models characterizing the relationship between nonlinear PSA kinetics and survival in prostate cancer patients.
Solène Desmée, France Mentré, Christine Veyrat-Follet, Bernard Sébastien, Jérémie Guedj

Biometrics· March 2017

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Model averaging inconcentration-QT analyses.
Bernard Sébastien, David Hoffman, Clémence Rigaux, Franck Pellissier, Jérôme Msihid

Pharm Stat· November 2016

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A drug and disease model for lixisenatide, a GLP-1 receptor agonist in type 2 diabetes.
Justin J Wilkins, Michel Dubar, Bernard Sébastien, Christian Laveille

J Clin Pharmacol· March 2014

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Comment on: Cheng, Chow, Burt, and Cosmatos (2008). Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variables. Journal of Biopharmaceutical Statistics 18(3):494-501.
Bernard Sebastien

J Biopharm Stat· September 2010

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