Evaluation of equivalence of two formulations of a drug typically entails the comparison of average bioavailabilities. Recently, however, authors have become aware that this may be insufficient to assess individual bioequivalence, that is, interchangeability of formulations on an individual basis. T
The basis for individual bioequivalence
β Scribed by R. L. Williams; R. N. Patnaik; M-L. Chen; FDA Population and Individual Bioequivalence Working Group
- Book ID
- 105731516
- Publisher
- Springer-Verlag
- Year
- 2000
- Tongue
- English
- Weight
- 524 KB
- Volume
- 25
- Category
- Article
- ISSN
- 0378-7966
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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test procedure for assessing individual (or population) bioequivalence between two drug formulations is suggested in a draft guidance from the United States Food and Drug Administration (FDA).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
In December of 1997, the FDA proposed a draft guidance for future in vivo bioequivalence studies.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