𝔖 Bobbio Scriptorium
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Interval Estimation for Ratios in Bioequivalence Trials

✍ Scribed by Keh-Wei Chen; Gang Li; Yanqing Sun; Shein-Chung Chow

Publisher
John Wiley and Sons
Year
1997
Tongue
English
Weight
573 KB
Volume
39
Category
Article
ISSN
0323-3847

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✦ Synopsis

Rinceton, N.J.

USA summrrry

The problem for assessment of equivalence in variability of bioavailability between two drug products is considered. An exact confidence region for the ratio between intrasubject variabilities is derived when the intersubject variance is known. When the intersubject variance is unknown, a large sample approximation is considered. The proposed method for assessing equivalence in variability of bioavailability appears to be asymptotically uncorrelated with the sample mean ratio for average bioavailabilty.

a result, the proposed method in conjunction with the sample mean ratio method can be utilized for assessing population bioequivalence. An example concerning a bioequivalence trial with 24 healthy volunteers is presented to illustrate the proposed method.

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