𝔖 Bobbio Scriptorium
✦   LIBER   ✦

Statistical considerations in bioequivalence trials

✍ Scribed by Chow, Shein-Chung; Liu, Jen-Pei


Book ID
120249471
Publisher
Taylor and Francis Group
Year
1994
Tongue
English
Weight
714 KB
Volume
23
Category
Article
ISSN
0361-0926

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In December of 1997, the FDA proposed a draft guidance for future in vivo bioequivalence studies.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

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