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Showing 1–3 of 3 results
Advanced filters: Author: Maria Mavris Clear advanced filters

  • Animal models are vital tools in the development of therapies for orphan diseases, given the small populations of patients available to evaluate the therapies. Here, Sepodes and colleagues from the European Medicines Agency's Committee for Orphan Medicinal Products harness their experience to provide an overview of the animal models used to support regulatory applications for metabolic, neuromuscular and ophthalmological rare diseases.

    • Guillaume Vaquer
    • Frida Rivière Dannerstedt
    • Bruno Sepodes
    Reviews
    Nature Reviews Drug Discovery
    Volume: 12, P: 287-305

  • The European Medicines Agency and the US Food and Drug Administration have committed to engaging patients in their regulatory processes to promote patient-focused medicinal product development, as well as improve transparency and trust in the regulatory system. Here, we highlight exchanges of experience between the agencies and some impacts on patient engagement.

    • Maria Mavris
    • Andrea Furia Helms
    • Nathalie Bere
    Comments & Opinion
    Nature Reviews Drug Discovery
    Volume: 18, P: 885-886

  • Zoned crystals may reflect magma chamber dynamics, where changes in temperature, pressure and timescale before volcanic eruption may be measured. Petrone et al. develop a new Non-Isothermal Diffusion Incremental Step model to reconstruct crystal lifetime histories to constrain pre-eruptive magmatic processes.

    • Chiara Maria Petrone
    • Giuseppe Bugatti
    • Simone Tommasini
    ResearchOpen Access
    Nature Communications
    Volume: 7, P: 1-11