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FDAnews Drug Daily Bulletin
Oct. 10, 2012 | Vol. 9 No. 199
Health Canada May Allow Sponsors to Skirt Human Bioavailability Studies
Drug sponsors may be able to avoid establishing in vivo bioequivalence as part of safety and efficacy data requirements in situations where in vitro data provides a reasonable estimate of the relative in vivo performance of the two products, according to a new Health Canada draft guidance. The August draft details the application process for a biopharmaceutics classification system-based biowaver and applies only to BCS Class I and III drugs. Class I drug substances are classified as having high solubility and high absorption, while Class III drugs have high solubility and low absorption.
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