Animal Model

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Animal models for metabolic, neuromuscular and ophthalmological rare diseases

Published by Macmillan Publishers Limited

Animal ModelFeline ModelInfrafrontierMouse ModelNeuromuscular DiseaseOphtalmological Disease

the article provides a compilation of mammalian animal
models for metabolic, neuromuscular and ophthalmological orphan-designated conditions
based on information gathered by the EMA’s Committee for Orphan Medicinal Products (COMP). It is discussed the predictive value of the models and their advantages and limitations with the aim of highlighting those that are appropriate for the preclinical evaluation of novel
therapies, thereby facilitating further drug development for rare diseases.

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FDA Qualification process – Drug Development Tools

Published by IRDiRC

Animal ModelBiomarkerCenter for Drug Evaluation and ResearchClinical DevelopmentDrug Development ToolEndpointQualification ProcessRegulatory AffairsResearch and Drug Development

This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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