Cuando el formato de administración es el producto: el modelo de licenciamientos listos en Films Orales

There is a conventional way to think about Oral Films: as a formulation alternative to tablets. Easier to swallow, faster to dissolve, better adherence in certain patient populations. Useful, but secondary to the molecule. A recently announced licensing agreement in the Oral Films space challenges that framing. The deal combines [...]

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Qué significa la nueva guía de calidad del CTD de la FDA para el desarrollo farmacéutico

The regulatory landscape of pharmaceutical development continues to evolve, and recent updates from the US Food and Drug Administration (FDA) highlight how companies will need to adapt their documentation and quality strategies in the coming years. The FDA has released a draft revision of the Common Technical Document (CTD) Quality [...]

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