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dc.contributor.authorGupta, E
dc.contributor.authorBarends, D M
dc.contributor.authorYamashita, E
dc.contributor.authorLentz, K A
dc.contributor.authorHarmsze, A M
dc.contributor.authorShah, V P
dc.contributor.authorDressman, J B
dc.contributor.authorLipper, R A
dc.date.accessioned2006-12-21T10:15:35Z
dc.date.available2006-12-21T10:15:35Z
dc.date.issued2006-11-01
dc.identifier.citationEur J Pharm Sci 2006, 29(3-4):315-24en
dc.identifier.issn0928-0987
dc.identifier.pmid16806858
dc.identifier.doi10.1016/j.ejps.2006.05.001
dc.identifier.urihttp://hdl.handle.net/10029/6694
dc.description.abstractThe regulations with respect to biowaivers for immediate release (IR) solid oral dosage forms in the USA, the EU, Japan and from the World Health Organization (WHO) are summarized and compared. Two case studies are presented, one from our own files and one from the open literature, showing the similarities and the differences among the qualification requirements of the four systems. The regulatory experience gained up to now is reviewed and expected future trends are discussed.
dc.format.extent127810 bytes
dc.format.mimetypeapplication/pdf
dc.language.isoenen
dc.titleReview of global regulations concerning biowaivers for immediate release solid oral dosage forms.en
dc.typeArticleen
dc.format.digYES
refterms.dateFOA2018-12-18T14:38:37Z
html.description.abstractThe regulations with respect to biowaivers for immediate release (IR) solid oral dosage forms in the USA, the EU, Japan and from the World Health Organization (WHO) are summarized and compared. Two case studies are presented, one from our own files and one from the open literature, showing the similarities and the differences among the qualification requirements of the four systems. The regulatory experience gained up to now is reviewed and expected future trends are discussed.


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