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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Detalhes bibliográficos
Publicado no:J Pharm Sci
Main Authors: 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: Artigo
Idioma:Inglês
Publicado em: American Pharmacists Association®. Published by Elsevier Inc. 2016
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Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7126353/
https://ncbi.nlm.nih.gov/pubmed/26952879
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.xphs.2016.01.017
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