uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
The use of BDDCS in classifying the permeability of marketed drugs
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
Show others and affiliations
2008 (English)In: Pharmaceutical research, ISSN 0724-8741, E-ISSN 1573-904X, Vol. 25, no 3, 483-488 p.Article in journal (Refereed) Published
Abstract [en]

We recommend that regulatory agencies add the extent of drug metabolism (i.e., >or=90% metabolized) as an alternate method in defining Class 1 marketed drugs suitable for a waiver of in vivo studies of bioequivalence. That is, >or=90% metabolized is an additional methodology that may be substituted for >or=90% absorbed. We propose that the following criteria be used to define>or=90% metabolized for marketed drugs: Following a single oral dose to humans, administered at the highest dose strength, mass balance of the Phase 1 oxidative and Phase 2 conjugative drug metabolites in the urine and feces, measured either as unlabeled, radioactive labeled or nonradioactive labeled substances, account for >or=90% of the drug dosed. This is the strictest definition for a waiver based on metabolism. For an orally administered drug to be >or=90% metabolized by Phase 1 oxidative and Phase 2 conjugative processes, it is obvious that the drug must be absorbed. This proposal, which strictly conforms to the present>or=90% criteria, is a suggested modification to facilitate a number of marketed drugs being appropriately assigned to Class 1.

Place, publisher, year, edition, pages
Springer , 2008. Vol. 25, no 3, 483-488 p.
Keyword [en]
BCS, BDDCS, bioequivalence, elimination pathways
National Category
Pharmaceutical Sciences
URN: urn:nbn:se:uu:diva-86832DOI: 10.1007/s11095-007-9523-xPubMedID: 18236138OAI: oai:DiVA.org:uu-86832DiVA: diva2:127494
Available from: 2008-12-08 Created: 2008-12-08 Last updated: 2010-07-20Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full textPubMed

Search in DiVA

By author/editor
Lennernäs, Hans
By organisation
Department of Pharmacy
In the same journal
Pharmaceutical research
Pharmaceutical Sciences

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 201 hits
ReferencesLink to record
Permanent link

Direct link