𝔖 Bobbio Scriptorium
✦   LIBER   ✦

TOLERANCE INTERVALS FOR ASSESSING INDIVIDUAL BIOEQUIVALENCE

✍ Scribed by EILEEN B. BROWN; HARI K. IYER; C. MING WANG

Publisher
John Wiley and Sons
Year
1997
Tongue
English
Weight
276 KB
Volume
16
Category
Article
ISSN
0277-6715

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✦ Synopsis

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. This paper outlines a tolerance interval procedure to assess individual bioequivalence based on a model that includes a subject by formulation interaction. We give methods for several higher-order cross-over designs along with examples.

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