Clinical bioequivalence

2/26/01


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Table of Contents

Clinical bioequivalence

Specific example

Clinical bioequivalence

Clinical bioequivalence

Clinical bioequivalence

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Manufacturer proposal

Initial assumptions

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To determine the number of subjects (n) required to detect a difference d with confidence a and power 1 - b with the two one-sided test approach, use the following:

For a = 0.05 and b = 0.2:

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Conclusions

Advisory Committee discussion

 Author: CBER