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Clinical Trials Advisor
Sept. 27, 2012 | Vol. 17 No. 19
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a reasonable estimate of the relative in vivo performance of the two products, according to a new Health Canada draft guidance.
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