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Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system
H Vogelpoel1, J Welink, G L Amidon
1RIVM-National Institute for Public Health and the Environment, Center for Quality of Chemical-Pharmaceutical Products, P.O. Box 1, 3720 BA Bilthoven, The Netherlands.
Abstract:
Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapamil hydrochloride, propranolol hydrochloride, and atenolol in the form of BCS-monographs. Data on the qualitative composition of immediate release (IR) tablets containing these active substances with a Marketing Authorization (MA) in the Netherlands (NL) are also provided; in view of these MA's the assumption was made that these tablets were bioequivalent to the innovator product. The development of a database with BCS-related data is announced by the International Pharmaceutical Federation (FIP).
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