Flora T. Musuamba

Brussels, BRU, Belgium

Last Updated: 09/26/2026

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Found 42 publications

From animal testing to model-informed drug development: building on ICH M15 and EMA initiatives to make new approach methodologies (NAMs) deliver.

From animal testing to model-informed drug development: building on ICH M15 and EMA initiatives to make new approach methodologies (NAMs) deliver.

Journal: Frontiers in pharmacology

Published: May 11, 2026

Why Pediatric CAR-T Therapies Still Lag Behind: Insights from Six Treatments Centrally Approved in Europe.

Why Pediatric CAR-T Therapies Still Lag Behind: Insights from Six Treatments Centrally Approved in Europe.

Journal: Clinical pharmacology and therapeutics

Published: December 16, 2025

Differences in Physiologically Based Pharmacokinetic Predictions between Software Platforms Can Be Clinically Relevant: Cases of Levornestrogel and Ethinylestradiol Concentrations with SIMCYP versus PK-Sim from a User Perspective.

Differences in Physiologically Based Pharmacokinetic Predictions between Software Platforms Can Be Clinically Relevant: Cases of Levornestrogel and Ethinylestradiol Concentrations with SIMCYP versus PK-Sim from a User Perspective.

Journal: European journal of drug metabolism and pharmacokinetics

Published: September 16, 2025

Assessment and Benchmarking of Model Informed Approaches in Drug Development for Hemoglobinopathies: A Review of Scientific Advices From January 2000 to December 2024.

Assessment and Benchmarking of Model Informed Approaches in Drug Development for Hemoglobinopathies: A Review of Scientific Advices From January 2000 to December 2024.

Journal: CPT: pharmacometrics & systems pharmacology

Published: September 05, 2025

Model informed assessment of QT prolongation during drug development: a five-year retrospective analysis of EMA scientific advices.

Model informed assessment of QT prolongation during drug development: a five-year retrospective analysis of EMA scientific advices.

Journal: Journal of pharmacokinetics and pharmacodynamics

Published: September 04, 2025

Modeling and Simulation in Development and Regulatory Approval of Chimeric Antigen Receptor T-Cell Therapies: An Analysis of European Medicines Agency Centralized Procedures From 2018 to 2024.

Modeling and Simulation in Development and Regulatory Approval of Chimeric Antigen Receptor T-Cell Therapies: An Analysis of European Medicines Agency Centralized Procedures From 2018 to 2024.

Journal: CPT: pharmacometrics & systems pharmacology

Published: August 24, 2025

Use of Modeling and Simulation to Inform the Development of Monoclonal Antibodies to Treat Moderate-to-Severe Asthma: A Retrospective Review of EMA Centralized Procedure From 2014 to 2024.

Use of Modeling and Simulation to Inform the Development of Monoclonal Antibodies to Treat Moderate-to-Severe Asthma: A Retrospective Review of EMA Centralized Procedure From 2014 to 2024.

Journal: CPT: pharmacometrics & systems pharmacology

Published: August 24, 2025

Application of a Stochastic Simulation-estimation Approach to Optimize Pharmacokinetic Study Design in the Context of Paediatric Extrapolation: A Tool to Support Decision-making by Drug Sponsors and Regulators.

Application of a Stochastic Simulation-estimation Approach to Optimize Pharmacokinetic Study Design in the Context of Paediatric Extrapolation: A Tool to Support Decision-making by Drug Sponsors and Regulators.

Journal: Pharmaceutical research

Published: August 20, 2025

Advancing the frontier of rare disease modeling: a critical appraisal of in silico technologies.

Advancing the frontier of rare disease modeling: a critical appraisal of in silico technologies.

Journal: NPJ digital medicine

Published: May 24, 2025

AI-Driven Applications in Clinical Pharmacology and Translational Science: Insights From the ASCPT 2024 AI Preconference.

AI-Driven Applications in Clinical Pharmacology and Translational Science: Insights From the ASCPT 2024 AI Preconference.

Journal: Clinical and translational science

Published: December 19, 2024

Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products.

Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products.

Journal: Pharmaceutical research

Published: November 26, 2024

Advancing in Silico Clinical Trials for Regulatory Adoption and Innovation.

Advancing in Silico Clinical Trials for Regulatory Adoption and Innovation.

Journal: IEEE journal of biomedical and health informatics

Published: November 08, 2024

Showing 1-12 of 42

Last Updated: 09/26/2026