Publications by authors named "Dinah M Duarte"

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Navigating the orphan medicinal product designation: Evidence requirements for gene therapies in Europe.
Gloria M Palomo, Tomas Pose-Boirazian, Frauke Naumann-Winter, Enrico Costa, Dinah M Duarte

Mol Ther· June 2025

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Advancing rare disease treatment: EMA's decade-long insights into engineered adoptive cell therapy for rare cancers and orphan designation.
Maria Elisabeth Kalland, Tomas Pose-Boirazian, Gloria Maria Palomo, Frauke Naumann-Winter, Enrico Costa, Dinah M Duarte

Gene Ther· July 2024

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Trends from two decades of orphan designations in paediatric rare neuromuscular diseases.
Dinah M Duarte, Maria Beatriz da Silva Lima, Bruno Sepodes

J Neurol Sci· May 2024

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The European landscape for gene therapies in orphan diseases: 6-year experience with the EMA Committee for Orphan Medicinal Products.
Gloria M Palomo, Tomas Pose-Boirazian, Frauke Naumann-Winter, Enrico Costa, Dinah M Duarte

Mol Ther· December 2023

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The translational value of animal models in orphan medicines designations for rare paediatric neurological diseases.
Dinah M Duarte, Maria Beatriz da Silva Lima, Bruno Sepodes

Regul Toxicol Pharmacol· December 2020

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Rebuttal to Dr. Andrew and Dr. Keller letter to the Editor on "Juvenile animal studies in oncology medicines for children".
Dinah M Duarte

Reprod Toxicol· December 2016

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Use of juvenile animal studies to support oncology medicine development in children.
Dinah M Duarte

Reprod Toxicol· August 2015

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Juvenile animal studies in the development of pediatric medicines: experience from European medicines and pediatric investigation plans.
Dinah M Duarte, Beatriz Silva-Lima

Birth Defects Res B Dev Reprod Toxicol· August 2011

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