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Clinical Pharmacology and Therapeutics
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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 breastfeeding
Efthymios 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 Union
Falk Ehmann, Marisa Papaluca, Francesca Di Giuseppe, et al.
Paediatric Anaesthesia
|
January 20, 2011
Role of modeling and simulation in pediatric investigation plans
Efthymios 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 Perspectives
Scott 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 paediatrics
Cécile 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 perspective
Efthymios 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 Challenges
Flora 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 credibility
Flora T Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, et al.
Clinical Pharmacology and Therapeutics
|
August 3, 2023
Model-Informed Drug Development: Steps Toward Harmonized Guidance
Scott Marshall, Malidi Ahamadi, Jenny Chien, et al.
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Showing results (11-20 of 23) with videos related to
Sort By:
Page
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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 breastfeeding
Efthymios 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 Union
Falk Ehmann, Marisa Papaluca, Francesca Di Giuseppe, et al.
Paediatric Anaesthesia
|
January 20, 2011
Role of modeling and simulation in pediatric investigation plans
Efthymios 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 Perspectives
Scott 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 paediatrics
Cécile 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 perspective
Efthymios 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 Challenges
Flora 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 credibility
Flora T Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, et al.
Clinical Pharmacology and Therapeutics
|
August 3, 2023
Model-Informed Drug Development: Steps Toward Harmonized Guidance
Scott Marshall, Malidi Ahamadi, Jenny Chien, et al.
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of 3