About: Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin

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An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin
Creator	Abrahamsson, Bertil Cristofoletti, Rodrigo Goodarzi, Navid Langguth, Peter Dressman, Jennifer Groot, D Mehta, Mehul Morgani, Ahmadreza Polli, James Shah, Vinod
Source	Elsevier; Medline; PMC
abstract	Abstract 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 according to the Biopharmaceutical Classification System, and taking a “worst case” approach, ribavirin should be assigned to class III. As ribavirin is transported across the brush border membrane of the human jejunum by hCNT2, it shows saturable uptake in the intestine. However, no common excipients have been shown to compete for ribavirin absorption, nor have problems with BE of immediate release ribavirin formulations containing different excipients and produced by different manufacturing methods been reported in the open literature. So the risk of bioinequivalence caused by these factors appears to be low. Ribavirin is considered a narrow therapeutic index drug, as judged by comparing the minimum effective concentration and minimum toxic concentrations in blood. Although ribavirin would not be eligible for approval via a Biopharmaceutical Classification System–based biowaiver procedure according to today's guidances due to its narrow therapeutic index, the risks of biowaiving should be weighed against the considerable risks associated with studying BE of ribavirin products in healthy subjects.
has issue date	2016-04-30(xsd:dateTime)
bibo:doi	10.1016/j.xphs.2016.01.017
bibo:pmid	26952879
has license	els-covid
sha1sum (hex)	70bb6d4d2a1e4ca1eb10556fc78e6ec6944d7210
schema:url	https://doi.org/10.1016/j.xphs.2016.01.017
resource representing a document's title	Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin
has PubMed Central identifier	PMC7126353
has PubMed identifier	26952879
schema:publication	Journal of Pharmaceutical Sciences
resource representing a document's body	covid:70bb6d4d2a1e4ca1eb10556fc78e6ec6944d7210#body_text
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