Review of global regulations concerning biowaivers for immediate release solid oral dosage forms.

2.50
Hdl Handle:
http://hdl.handle.net/10029/6694
Title:
Review of global regulations concerning biowaivers for immediate release solid oral dosage forms.
Authors:
Gupta, E; Barends, D M; Yamashita, E; Lentz, K A; Harmsze, A M; Shah, V P; Dressman, J B; Lipper, R A
Abstract:
The 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.
Citation:
Eur J Pharm Sci 2006, 29(3-4):315-24
Issue Date:
1-Nov-2006
URI:
http://hdl.handle.net/10029/6694
DOI:
10.1016/j.ejps.2006.05.001
PubMed ID:
16806858
Type:
Article
Language:
en
ISSN:
0928-0987
Appears in Collections:
Public Health and Health Care

Full metadata record

DC FieldValue Language
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.en
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-

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