COMMENTARY Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms Based on Biopharmaceutics Classification System (BCS) Literature Data: Verapamil Hydrochloride, Propranolol Hydrochloride, and Atenolol
نویسنده
چکیده
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 assumptionwasmade that these tabletswerebioequivalent to the innovator product. The development of a database with BCS-related data is announced by the International Pharmaceutical Federation (FIP). 2004 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 93:1945–1956, 2004
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