Some statistical considerations on the F
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Francis C. Hsuan
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Article
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2000
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John Wiley and Sons
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English
β 56 KB
π 2 views
In December of 1997, the FDA proposed a draft guidance for future in vivo bioequivalence studies. The guidance suggested speciΓΏc criteria for new drug sponsors to show individual bioequivalence (IBE). The criteria use a mixed-scaling aggregate strategy. It has been generally accepted that, under som