𝔖 Bobbio Scriptorium
✦   LIBER   ✦

Consideration of individual bioequivalence

✍ Scribed by Sharon Anderson; Walter W. Hauck

Book ID
112473544
Publisher
Springer
Year
1990
Tongue
English
Weight
901 KB
Volume
18
Category
Article
ISSN
1573-8744

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πŸ“œ SIMILAR VOLUMES

Some statistical considerations on the F
Some statistical considerations on the FDA draft guidance for individual bioequivalence
✍ Francis C. Hsuan πŸ“‚ Article πŸ“… 2000 πŸ› John Wiley and Sons 🌐 English βš– 56 KB πŸ‘ 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In December of 1997, the FDA proposed a draft guidance for future in vivo bioequivalence studies.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

The basis for individual bioequivalence
The basis for individual bioequivalence
✍ R. L. Williams; R. N. Patnaik; M-L. Chen; FDA Population and Individual Bioequiv πŸ“‚ Article πŸ“… 2000 πŸ› Springer-Verlag 🌐 English βš– 524 KB
The bootstrap procedure in individual bi
The bootstrap procedure in individual bioequivalence
✍ Jun Shao; Shein-Chung Chow; Bill Wang πŸ“‚ Article πŸ“… 2000 πŸ› John Wiley and Sons 🌐 English βš– 101 KB

A bootstrap-type hypothesis test procedure for assessing individual (or population) bioequivalence between two drug formulations is suggested in a draft guidance from the United States Food and Drug Administration (FDA). The purpose of this article is to study the unknown properties of this test pro