Which statement about AB ratings is true?

Which statement about AB ratings is true?

• A. The AB rating indicates the product is not approved for sale
• B. The AB rating indicates the product is a biologic
• C. The AB rating indicates the product has no dosage form variations
• D. Actual or potential bioequivalence problems have been resolved and the product is therapeutically equivalent to pharmaceutically equivalent products

Answer: (D)

AB ratings are about therapeutic equivalence after confirming bioequivalence. When a product carries this rating, it means there are no unresolved bioavailability problems and it behaves the same as a pharmaceutically equivalent reference product in the body. In practical terms, the active ingredient, dose form, and strength match the reference, and studies have shown the two products are bioequivalent, so one can be substituted for the other under appropriate regulations. This rating does not indicate something about being a biologic, nor does it suggest there are no dosage form variations overall, and it does not mean the product is not approved for sale.

AB ratings are about therapeutic equivalence after confirming bioequivalence. When a product carries this rating, it means there are no unresolved bioavailability problems and it behaves the same as a pharmaceutically equivalent reference product in the body. In practical terms, the active ingredient, dose form, and strength match the reference, and studies have shown the two products are bioequivalent, so one can be substituted for the other under appropriate regulations. This rating does not indicate something about being a biologic, nor does it suggest there are no dosage form variations overall, and it does not mean the product is not approved for sale.