The biopharmaceutics classification system (BCS): class III drugs - better candidates for BA/BE waiver?
Current guidelines (CPMP Note for Guidance in Europe and FDA Guidance for Industry in the USA) consider a waiver of bioavailability/bioequivalence studies for immediate release dosage forms of highly soluble, highly permeable drug substances (Class I according to the BCS). In this paper, a waiver of BA/BE studies is being proposed also for Class III compounds (high solubility and low permeability) in fast dissolving products without excipients which may modify gastro-intestinal transit or membrane permeation. This type of drug substance may be an even better candidate for a waiver as, in this case, bioavailability will not so much depend on the formulation characteristics, as on drug substance properties (e.g. permeability).
Blume
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HH
SocraTec R&D, Feldbergstrasse 59, 61440, Oberursel, Germany. h.h.blume@t-online.de
Schug
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BS
D001682:Biological Availability; D001702:Biopharmaceutics / Q000145:classification*; D005060:Europe; D005772:Gastrointestinal Transit / Q000187:drug effects; D010539:Permeability; D017410:Practice Guidelines as Topic; D012995:Solubility; D013810:Therapeutic Equivalency; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration