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Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
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2011 (English)In: Clinical Pharmacology and Therapeutics, ISSN 0009-9236, E-ISSN 1532-6519, Vol. 90, no 3, 467-470 p.Article in journal (Refereed) Published
Abstract [en]

The demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Biopharmaceutics Classification System (BCS) sets a scientific basis for an improved BE standard for immediate-release solid oral dosage forms. In this paper, we discuss BE and the BCS, as well as the issues that are currently relevant to BE as a pharmaceutical product standard.

Place, publisher, year, edition, pages
2011. Vol. 90, no 3, 467-470 p.
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Medical and Health Sciences
URN: urn:nbn:se:uu:diva-158570DOI: 10.1038/clpt.2011.109ISI: 000294247900023OAI: oai:DiVA.org:uu-158570DiVA: diva2:440557
Available from: 2011-09-13 Created: 2011-09-12 Last updated: 2011-09-13Bibliographically approved

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