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Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives

A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug Products. Industrial Scientists that were involved in product devel...

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Detalles Bibliográficos
Autores principales: McAllister, Mark, Flanagan, Talia, Boon, Karin, Pepin, Xavier, Tistaert, Christophe, Jamei, Masoud, Abend, Andreas, Kotzagiorgis, Evangelos, Mackie, Claire
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7022466/
https://www.ncbi.nlm.nih.gov/pubmed/31878006
http://dx.doi.org/10.3390/pharmaceutics12010019