statistical methods in bioequivalence

Statistical methods in bioequivalence involve comparing two drug formulations to ensure they release the active ingredient into the bloodstream at similar rates and amounts. This typically includes calculating parameters like the average time to reach peak concentration and total exposure. Using statistical tests and confidence intervals, researchers determine if these values are sufficiently close—usually within 80-125%—to confirm that the generic version works just as effectively and safely as the original. This approach provides a scientific basis for approving generic drugs, ensuring consistency and reliability for patients.