Publications by authors named "Flora Musuamba"

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Advancing the frontier of rare disease modeling: a critical appraisal of in silico technologies.
Francesca Pistollato, Fabia Furtmann, Lindsay J Marshall, Surat Parvatam, Jan Turner, Flora Tshinanu Musuamba

NPJ Digit Med· November 2025

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Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products.
Ross L Walenga, Khondoker Alam, James F Clarke, Jan De Backer, Markus Fridén, Flora T Musuamba

Pharm Res· May 2025

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Advancing in Silico Clinical Trials for Regulatory Adoption and Innovation.
Georgia Karanasiou, Elazer Edelman, Francois-Henri Boissel, Robert Byrne, Luca Emili, Flora Musuamba

IEEE J Biomed Health Inform· April 2025

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AI-Driven Applications in Clinical Pharmacology and Translational Science: Insights From the ASCPT 2024 AI Preconference.
Mohamed H Shahin, Prashant Desai, Nadia Terranova, Yuanfang Guan, Tomáš Helikar, Flora T Musuamba

Clin Transl Sci· April 2025

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Hydroxychloroquine use during the first COVID-19 wave: a case study highlighting the urgent need to enhance research practices within the publication ecosystem.
Charlotte Beaudart, Flora Musuamba, Médéa Locquet, Jean-Michel Dogné, Jonathan Douxfils

Arch Public Health· April 2025

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EMA perspective on the value of model-informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding.
Efthymios Manolis, Flora Tshinanu Musuamba, Corinne S de Vries, Pieter J Colin, Martin B Oleksiewicz

CPT Pharmacometrics Syst Pharmacol· November 2024

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Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics.
Sihem Ait-Oudhia, Yow-Ming Wang, Anne-Gaelle Dosne, Amit Roy, Jin Y Jin, Flora T Musuamba

Clin Pharmacol Ther· March 2024

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Moving Toward a Question-Centric Approach for Regulatory Decision Making in the Context of Drug Assessment.
Flora T Musuamba, S Y Amy Cheung, Pieter Colin, Elin H Davies, Jeffrey S Barret

Clin Pharmacol Ther· July 2023

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Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework.
Ine Skottheim Rusten, Flora Tshinanu Musuamba

CPT Pharmacometrics Syst Pharmacol· November 2021

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Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility.
Flora T Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, Giulia Russo, Roberta Bursi

CPT Pharmacometrics Syst Pharmacol· August 2021

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The European Medicines Agency Experience With Pediatric Dose Selection.
Efthymios Manolis, Flora T Musuamba, Kristin E Karlsson

J Clin Pharmacol· June 2021

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Model informed dosing of hydroxycholoroquine in COVID-19 patients: Learnings from the recent experience, remaining uncertainties and gaps.
Pauline Thémans, Nicolas Dauby, Loïc Schrooyen, Faustine Lebout, Marc Delforge, Flora T Musuamba

Br J Clin Pharmacol· February 2021

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Population Pharmacokinetics of Hydroxychloroquine in COVID-19 Patients: Implications for Dose Optimization.
Pauline Thémans, Leila Belkhir, Nicolas Dauby, Jean-Cyr Yombi, Julien De Greef, Flora T Musuamba

Eur J Drug Metab Pharmacokinet· December 2020

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Dose Rationale for Amoxicillin in Neonatal Sepsis When Referral Is Not Possible.
Salvatore D'Agate, Flora Tshinanu Musuamba, Oscar Della Pasqua

Front Pharmacol· September 2020

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Regulatory Considerations for Building an In Silico Clinical Pharmacology Backbone by 2030.
Efthymios Manolis, Flora T Musuamba, Kristin E Karlsson

Clin Pharmacol Ther· April 2020

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Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges.
Flora T Musuamba, Roberta Bursi, Efthymios Manolis, Kristin Karlsson, Alexander Kulesza

CPT Pharmacometrics Syst Pharmacol· April 2020

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Toward a robust tool for pharmacokinetic-based personalization of treatment with tacrolimus in solid organ transplantation: A model-based meta-analysis approach.
Tom M Nanga, Thao T P Doan, Pierre Marquet, Flora T Musuamba

Br J Clin Pharmacol· December 2019

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Towards a Generic Tool for Prediction of Meropenem Systemic and Infection-Site Exposure: A Physiologically Based Pharmacokinetic Model for Adult Patients with Pneumonia.
Pauline Thémans, Pierre Marquet, Joseph J Winkin, Flora T Musuamba

Drugs R D· June 2019

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Commentary on the MID3 Good Practices Paper.
Efthymios Manolis, Jacob Brogren, Susan Cole, Justin L Hay, Anna Nordmark, Flora Tshinanu Musuamba

CPT Pharmacometrics Syst Pharmacol· July 2017

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Modelled target attainment after meropenem infusion in patients with severe nosocomial pneumonia: the PROMESSE study.
Frédéric Frippiat, Flora Tshinanu Musuamba, Laurence Seidel, Adelin Albert, Raphaël Denooz

J Antimicrob Chemother· January 2015

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Prediction of paraquat exposure and toxicity in clinically ill poisoned patients: a model based approach.
Klintean Wunnapuk, Fahim Mohammed, Indika Gawarammana, Xin Liu, Roger K Verbeeck, Flora T Musuamba

Br J Clin Pharmacol· October 2014

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Is plasma and urine neutrophil gelatinase-associated lipocalin (NGAL) determination in donors and recipients predictive of renal function after kidney transplantation?
Antoine Buemi, Flora Musuamba, Stephan Frederic, Anne Douhet, Martine De Meyer

Clin Biochem· October 2014

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Influence of donor-recipient CYP3A4/5 genotypes, age and fluconazole on tacrolimus pharmacokinetics in pediatric liver transplantation: a population approach.
Vanessa Guy-Viterbo, Henry Baudet, Laure Elens, Vincent Haufroid, Florence Lacaille, Flora Musuamba

Pharmacogenomics· June 2014

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Population pharmacokinetic analysis of tacrolimus early after pediatric liver transplantation.
Flora T Musuamba, Vanessa Guy-Viterbo, Raymond Reding, Roger K Verbeeck, Pierre Wallemacq

Ther Drug Monit· February 2014

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Population pharmacokinetic analysis of tacrolimus in the first year after pediatric liver transplantation.
V Guy-Viterbo, A Scohy, R K Verbeeck, R Reding, P Wallemacq, Flora Tshinanu Musuamba

Eur J Clin Pharmacol· August 2013

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