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Sample Size for BE Study
How can select the sample size for BE study?
There should have a sufficient number of subjects for the bioequivalence analysis. It depends on the type of study and the availability of samples.
For example, the standard 2×2 cross-over study will use a particular calculation while studies with a different design or set of endpoints will use different calculations.
FDA recommends that applicants should enroll enough subjects to power the study at a level of 0.8 or higher, for a BE test to be carried out with a type 1 error rate of 0.05.
Applicants should consider also dropout chance. A sufficient number of subjects should enroll in the study to allow for dropouts. Dropouts generally should not be replaced because replacement of subjects during the study could complicate the statistical model and analysis.
For complex study designs with no analytical solutions for sample size calculation, simulation can be used to estimate the needed sample size in order to reach a desired power.
What is the minimum number of subjects required for a BE study?
As per EMA guideline, at least 12 subjects are required for BE study.