Bioequivalence testing criteria

A high degree of sensitivity of in vitro dissolution tests to formulation differences raises questions about the appropriate acceptance criteria—how similar should two in vitro dissolution profiles be to be considered similar The SUPAC-IR introduced to the regulatory decision-making process a metric referred to as f2 [43] for profile comparison. Application of this criterion to the examples cited in this report (e.g., piroxicam formulations) would have resulted in a recommendation for the in vivo bioequivalence study. 

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Bioequivalence Criterion and the Population Bioequivalence Criterion. The Individual Bioequivalence Criterion calls for a replicate study design, whereas the Population Bioequivalence Criterion does not involve a replicate study design, but a replicate crossover design or parallel design, which can also be used for this criterion. A replicate study design is one in which both the test and the reference drug products are administered to the same individuals on two separate occasions. 

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