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Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch

This paper presents a rational workflow for developing enabling formulations, such as amorphous solid dispersions, via hot-melt extrusion in less than a year. First, our approach to an integrated product and process development framework is described, including state-of-the-art theoretical concepts,...

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Detalles Bibliográficos
Autores principales: Matić, Josip, Paudel, Amrit, Bauer, Hannes, Garcia, Raymar Andreina Lara, Biedrzycka, Kinga, Khinast, Johannes G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7308264/
https://www.ncbi.nlm.nih.gov/pubmed/32572701
http://dx.doi.org/10.1208/s12249-020-01713-0