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Efthymios Manolis

Showing results (11-20 of 23) with videos related to

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Clinical Pharmacology and Therapeutics|June 4, 2025
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, et al.
CPT: Pharmacometrics & Systems Pharmacology|August 13, 2024
EMA perspective on the value of model-informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeedingEfthymios Manolis, Flora Tshinanu Musuamba, Corinne S de Vries, et al.
Expert Opinion on Pharmacotherapy|March 17, 2015
Changes and determination of dosing recommendations for medicinal products recently authorised in the European UnionFalk Ehmann, Marisa Papaluca, Francesca Di Giuseppe, et al.
Paediatric Anaesthesia|January 20, 2011
Role of modeling and simulation in pediatric investigation plansEfthymios Manolis, Tariq Eldirdiry Osman, Ralf Herold, et al.
CPT: Pharmacometrics & Systems Pharmacology|November 10, 2018
Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future PerspectivesScott Marshall, Rajanikanth Madabushi, Efthymios Manolis, et al.
British Journal of Clinical Pharmacology|February 2, 2019
Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatricsCécile Ollivier, Andrew Thomson, Efthymios Manolis, et al.
CPT: Pharmacometrics & Systems Pharmacology|January 11, 2023
Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspectiveEfthymios Manolis, Alfredo García-Arieta, Anders Lindahl, et al.
CPT: Pharmacometrics & Systems Pharmacology|April 3, 2020
Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and ChallengesFlora T Musuamba, Roberta Bursi, Efthymios Manolis, et al.
CPT: Pharmacometrics & Systems Pharmacology|June 8, 2021
Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibilityFlora T Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, et al.
Clinical Pharmacology and Therapeutics|August 3, 2023
Model-Informed Drug Development: Steps Toward Harmonized GuidanceScott Marshall, Malidi Ahamadi, Jenny Chien, et al.
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Showing results (11-20 of 23) with videos related to

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Pageof 3
Clinical Pharmacology and Therapeutics|June 4, 2025
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, et al.
CPT: Pharmacometrics & Systems Pharmacology|August 13, 2024
EMA perspective on the value of model-informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeedingEfthymios Manolis, Flora Tshinanu Musuamba, Corinne S de Vries, et al.
Expert Opinion on Pharmacotherapy|March 17, 2015
Changes and determination of dosing recommendations for medicinal products recently authorised in the European UnionFalk Ehmann, Marisa Papaluca, Francesca Di Giuseppe, et al.
Paediatric Anaesthesia|January 20, 2011
Role of modeling and simulation in pediatric investigation plansEfthymios Manolis, Tariq Eldirdiry Osman, Ralf Herold, et al.
CPT: Pharmacometrics & Systems Pharmacology|November 10, 2018
Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future PerspectivesScott Marshall, Rajanikanth Madabushi, Efthymios Manolis, et al.
British Journal of Clinical Pharmacology|February 2, 2019
Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatricsCécile Ollivier, Andrew Thomson, Efthymios Manolis, et al.
CPT: Pharmacometrics & Systems Pharmacology|January 11, 2023
Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspectiveEfthymios Manolis, Alfredo García-Arieta, Anders Lindahl, et al.
CPT: Pharmacometrics & Systems Pharmacology|April 3, 2020
Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and ChallengesFlora T Musuamba, Roberta Bursi, Efthymios Manolis, et al.
CPT: Pharmacometrics & Systems Pharmacology|June 8, 2021
Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibilityFlora T Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, et al.
Clinical Pharmacology and Therapeutics|August 3, 2023
Model-Informed Drug Development: Steps Toward Harmonized GuidanceScott Marshall, Malidi Ahamadi, Jenny Chien, et al.
Pageof 3