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International Pharmaceutical Regulatory Monitor
September 2012 | Vol. 40 No. 9
Health Canada May Allow Drug 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 provide a reasonable estimate of the relative in vivo performance of the two products, according to new Health Canada draft guidance.
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