Publications by authors named "Efthymios Manolis"

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Reply to: "Current Use of PBPK Modeling in New Medicinal Product Approvals at EMA: A Clinical Appraisal of Voclosporin in Lupus Nephritis".
Polly Paul, Pieter J Colin, Flora Musuamba Tshinanu, Carolien Versantvoort, Efthymios Manolis

Clin Pharmacol Ther· September 2025

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Current Use of Physiologically Based Pharmacokinetic modeling in New Medicinal Product Approvals at EMA.
Polly Paul, Pieter J Colin, Flora Musuamba Tshinanu, Carolien Versantvoort, Efthymios Manolis

Clin Pharmacol Ther· March 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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Model-Informed Drug Development: Steps Toward Harmonized Guidance.
Scott Marshall, Malidi Ahamadi, Jenny Chien, Daisuke Iwata, Pavel Farkas, Efthymios Manolis

Clin Pharmacol Ther· November 2023

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Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective.
Efthymios Manolis, Alfredo García-Arieta, Anders Lindahl, Evangelos Kotzagiorgis, Jobst Limberg

CPT Pharmacometrics Syst Pharmacol· May 2023

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Drug Clearance in Neonates: A Combination of Population Pharmacokinetic Modelling and Machine Learning Approaches to Improve Individual Prediction.
Bo-Hao Tang, Zheng Guan, Karel Allegaert, Yue-E Wu, Efthymios Manolis

Clin Pharmacokinet· 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, Efthymios Manolis

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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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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Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics.
Cécile Ollivier, Andrew Thomson, Efthymios Manolis, Kevin Blake, Kristin E Karlsson

Br J Clin Pharmacol· April 2019

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Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives.
Scott Marshall, Rajanikanth Madabushi, Efthymios Manolis, Kevin Krudys, Alexander Staab

CPT Pharmacometrics Syst Pharmacol· February 2019

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

CPT Pharmacometrics Syst Pharmacol· July 2017

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Chest imaging in CF studies - Commentary.
Irmgard Eichler, Efthymios Manolis

J Cyst Fibros· March 2017

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Hollow Fiber System Model for Tuberculosis: The European Medicines Agency Experience.
Marco Cavaleri, Efthymios Manolis

Clin Infect Dis· August 2015

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The European Medicines Agency experience with biomarker qualification.
Efthymios Manolis, Armin Koch, Dieter Deforce, Spiros Vamvakas

Methods Mol Biol· July 2015

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Changes and determination of dosing recommendations for medicinal products recently authorised in the European Union.
Falk Ehmann, Marisa Papaluca, Francesca Di Giuseppe, Luca Pani, Andrea Eskova, Efthymios Manolis

Expert Opin Pharmacother· April 2015

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Implementation of proteomic biomarkers: making it work.
Harald Mischak, John P A Ioannidis, Angel Argiles, Teresa K Attwood, Erik Bongcam-Rudloff, Efthymios Manolis

Eur J Clin Invest· September 2012

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Pharmacometrics for regulatory decision making: status and perspective.
Efthymios Manolis, Ralf Herold

Clin Pharmacokinet· October 2011

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New pathway for qualification of novel methodologies in the European Medicines Agency.
Efthymios Manolis, Spiros Vamvakas, Maria Isaac

Proteomics Clin Appl· June 2011

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Role of modeling and simulation in pediatric investigation plans.
Efthymios Manolis, Tariq Eldirdiry Osman, Ralf Herold, Franz Koenig, Paolo Tomasi

Paediatr Anaesth· March 2011

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Proposals for model-based paediatric medicinal development within the current European Union regulatory framework.
Efthymios Manolis, Gérard Pons

Br J Clin Pharmacol· October 2009

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Ribavirin pharmacokinetics in renal and liver transplant patients: evidence that it depends on renal function.
Nassim Kamar, Etienne Chatelut, Efthymios Manolis, Thierry Lafont, Jacques Izopet

Am J Kidney Dis· January 2004

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