The European-funded project Smart-4-Fabry has been conceived to obtain a new nanoformulation of GLA enzyme using nanocapsules, that will improve the toleration and efficacy compared to the current enzyme replacement treatment with non-formulated GLA. The innovation aims to achieve a significant reduction of the actual high cost of Fabry disease treatment and an improvement in the quality of life of Fabry disease patients.
Join the final project workshop on 03-FEB-2021. Details and more information about the project under https://smart4fabry.eu
We are pleased to announce that we have prepared some useful content from our Webinar "Informed decisions in dermal drug development with dOFM". Please find below a collection of valuable insights, a comprehensive Q&A Catalogue and easy access to all relevant resources. Browse through a collection of questions raised by our listeners during the live webinar to see which topics are particularly relevant for our audience. Take a more detailed look at the slides and download the presentation including some additional notes from our dOFM experts.
The U.S. Food and Drug Administration recently published a video showing the potential of dermal open-flow microperfusion (dOFM) for generic drug development.
FDA approval for most topical generic drugs requires a clinical endpoint study to compare the therapeutic effect with the original product. JOANNEUM RESEARCH HEALTH has developed a new method and strategy (dOFM) to apply for the approval of generic drugs without the need of a clinical endpoint study. Now, the FDA has released a short video illustrating the use of dOFM to evaluate bioequivalence for topical drugs.