A new generic tablet is compared with the innovator brand in a bioequivalence study. According to standard regulatory criteria (FDA/EMA), what parameter ranges must the generic satisfy to be declared bioequivalent?

• A 90% confidence interval of the ratio of AUC only must fall within 80% to 125%
• B 90% confidence interval of the ratio of AUC and Cmax must fall within 90% to 110%
• C The generic must have identical AUC and Cmax values to the innovator
• D 90% confidence interval of the ratio of AUC and Cmax must fall within 80% to 125% ✓

Explanation

Standard bioequivalence criteria require the 90% confidence interval for the geometric mean ratio (test/reference) of both AUC (extent of absorption) and Cmax (rate of absorption) to fall entirely within 80% to 125%. This is the accepted regulatory standard from both FDA and EMA. Narrow therapeutic index drugs sometimes have tighter Cmax limits, but the standard range is 80-125%.

Reference: Goodman and Gilman's The Pharmacological Basis of Therapeutics, 14th ed.

High-yield for: NEET PGINI-CETNExTFMGEUSMLEPLABMRCP

Written and medically reviewed by the StethoPrep medical team.