A generic tablet formulation is being evaluated for bioequivalence against the reference product. According to standard regulatory convention accepted in Indian and international guidelines, bioequivalence is typically concluded when:

• A The mean AUC ratio of test to reference exceeds 1.0 exactly
• B The 90% confidence interval of the test/reference ratios for AUC and Cmax falls within 80% to 125% ✓
• C The test product achieves at least 80% of the reference Cmax in every individual subject
• D The disintegration and dissolution times of both products are identical

Explanation

Bioequivalence studies use a crossover design in healthy volunteers, and equivalence is declared when the 90% confidence interval for the geometric mean test/reference ratios of AUC (extent) and usually Cmax (rate) lies entirely within the 80 to 125% acceptance range. Option A ignores variability and confidence limits. Option C imposes a per-subject criterion that no guideline uses. Option D describes pharmaceutical equivalence parameters, which alone do not establish bioequivalence.

Reference: Katzung's Basic and Clinical Pharmacology, 15th ed.

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