Statistical aspects of bioequivalence assessment in the pharmaceutical industry

Since the early 1990's, average bioequivalence studies have served as the international standard for demonstrating that two formulations of drug product will provide the same therapeutic benefit and safety profile when used in the marketplace. Population (PBE) and Individual (IBE) bioequivalenc...

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Bibliographic Details
Main Author: Patterson, Scott Daniel
Published: University College London (University of London) 2003
Subjects:
Online Access:http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.407352