Molecular Pharmaceutics
Researchers from University of Maryland describe findings in molecular pharmaceutics
Published in Drug Week, November 19th, 2010
"The Biopharmaceutics Classification System (BCS) is employed to waive in vivo bioequivalence testing (i.e. provide ''biowaivers'') for new and generic drugs that are BCS class I. Granting biowaivers under systems such as the BCS eliminates unnecessary drug exposures to healthy subjects and provides economic relief, while maintaining the high public health standard for therapeutic equivalence. International scientific consensus suggests class III drugs are also eligible for biowaivers," investigators in the United States report.
"The objective of this study was to estimate the economic impact of class I BCS-based biowaivers, along with the economic impact of a potential...
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Source: Drug Week (2010-11-19)
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