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An individual bioequivalence criterion: regulatory considerations

✍ Scribed by Mei-Ling Chen; Rabindra Patnaik; Walter W. Hauck; Donald J. Schuirmann; Terry Hyslop; Roger Williams


Publisher
John Wiley and Sons
Year
2000
Tongue
English
Weight
656 KB
Volume
19
Category
Article
ISSN
0277-6715

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In December of 1997, the FDA proposed a draft guidance for future in vivo bioequivalence studies.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