Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore accordi...

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Detalles Bibliográficos
Autores principales: Goodarzi, Navid, Barazesh Morgani, Ahmadreza, Abrahamsson, Bertil, Cristofoletti, Rodrigo, Groot, D.W., Langguth, Peter, Mehta, Mehul U., Polli, James E., Shah, Vinod P., Dressman, Jennifer B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Pharmacists Association®. Published by Elsevier Inc. 2016
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7126353/
https://www.ncbi.nlm.nih.gov/pubmed/26952879
http://dx.doi.org/10.1016/j.xphs.2016.01.017

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