Regulations of Bioavailability and Bioequivalence Studies Article 3

The terms used in the Regulation defined as follows:1.Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are no intended to be absorbed into the blood stream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.2.Pharmaceutical equivalents means drug products in identical dosage forms that contain identical amounts of the identical active drug ingredient, and meets either the identical compendial or other applicable quality standards provided by the central competent health authority.3.Pharmaceutical alternatives means drug products that contain the identical therapeutic moiety, or its precursor, but not necessarily in the same amount or dosage form or as the same salt or ester. Testing specifications of the drug product should meets either the identical compendial or other applicable quality standards provided by the central competent health authority.Bioequivalence means the absence of a significant difference in the bioavailability between two pharmaceutical equivalents or pharmaceutical alternatives when administered at the same molar dose under similar conditions in an appropriately designed study.