What variability is allowed in bioequivalence statistics?

What variability is allowed in bioequivalence statistics?

• A. +/-5%
• B. +/-10%
• C. +/-20%
• D. +/-50%

Answer: (C)

In bioequivalence, you’re assessing whether two products deliver similar exposure, typically using the ratio of key PK metrics (like AUC and Cmax) comparing test to reference. The allowed variability is defined by an equivalence window: the 90% confidence interval for this ratio must lie between 80% and 125%. That window translates to a ±20% range around 1.0, meaning about a 20% difference in either direction is considered acceptable. So the allowed variability is plus or minus 20 percent. The other options would impose changes tighter or looser than the standard regulatory criteria (5%, 10%, or 50%), which aren’t the accepted BE standard.

In bioequivalence, you’re assessing whether two products deliver similar exposure, typically using the ratio of key PK metrics (like AUC and Cmax) comparing test to reference. The allowed variability is defined by an equivalence window: the 90% confidence interval for this ratio must lie between 80% and 125%. That window translates to a ±20% range around 1.0, meaning about a 20% difference in either direction is considered acceptable. So the allowed variability is plus or minus 20 percent. The other options would impose changes tighter or looser than the standard regulatory criteria (5%, 10%, or 50%), which aren’t the accepted BE standard.