ABSTRACT
The design of bioequivalence studies is a vast topic and there are numerous R packages to analyze the data. Bioequivalence is the study of two drugs for comparability of their bioavailability at the site of action. For example, two drugs with the same active ingredient may have different routes of administration and may need to be compared for bioequivalence. Another example is a drug, which may have changed its formulation during the drug development process and needs to be compared to the original formulation. The Two One-Sided t-Tests procedure was developed to compare test and reference products for bioequivalence. There are many designs of bioequivalence studies, such as the parallel design, multiarm parallel, replicate, crossovers, and others. Power and sample size and confidence interval calculations are automated for a variety of bioequivalence designs including, parallel, crossover, crossover replicate, partial replicates, repeated crossovers, paired means, and others.
