Search Results - Flora T Musuamba

The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action by Roger K Verbeeck, Flora T Musuamba

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

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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 by Pauline Thémans, Pierre Marquet, Joseph J. Winkin, Flora T. Musuamba

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

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

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Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges by Flora T. Musuamba, Roberta Bursi, Efthymios Manolis, Kristin Karlsson, Alexander Kulesza, Eulalie Courcelles, Jean‐Pierre Boissel, Raphaëlle Lesage, Cécile Crozatier, Emmanuelle M. Voisin, Cécile F. Rousseau, Thierry Marchal, Rossana Alessandrello, Liesbet Geris

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Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility by Flora T. Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, Giulia Russo, Roberta Bursi, Luca Emili, Gaby Wangorsch, Efthymios Manolis, Kristin E. Karlsson, Alexander Kulesza, Eulalie Courcelles, Jean‐Pierre Boissel, Cécile F. Rousseau, Emmanuelle M. Voisin, Rossana Alessandrello, Nuno Curado, Enrico Dall'ara, Blanca Rodriguez, Francesco Pappalardo, Liesbet Geris

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