Dosing by Labeled Concentration

The potency of the pioneer and generic products should be assayed prior to conducting the BE study to ensure that the FDA or compendial specifications are met. The Center recommends that the potency of the pioneer and generic lots should differ by no more than + 5% for dosage form products.

The animals should be dosed according to the labeled concentration or strength of the product, rather than the assayed potency of the individual batch (i.e., the dose should not be corrected for the assayed potency of the product). The BE data or derived parameters should not be normalized to account for any potency differences between the pioneer and generic product lots.

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