Bioavailability  indicates a measurement of the rate and extent (amount) of therapeutically active drug which reaches the general circulation.
Bioequivalent Drug Products  means pharmaceutical equivalents or pharmaceutical alternatives whose rate and extent of absorption do not show a significant difference when administered at the same molar dose of the therapeutic moiety under similar experimental conditions, either single dose or multiple dose. Some pharmaceutical equivalents or pharmaceutical alternatives may be equivalent in the extent of their absorption but not in their rate of absorption and yet may be considered bioequivalent because such differences in the rate of absorption are intentional and are reflected in the labeling, are not essential to the attainment of effective body drug concentrations on chronic use, or are considered medically insignificant for the particular drug product studied.
Bioequivalence Requirement  means a requirement imposed by the Food and Drug Administration for the in vitro and/or in vivo testing of specified drug products which must be satisfied as a condition of marketing.
Brand Name  is the trade name of the drug.
Chemical Name  is the name used by the organic chemist to indicate the chemical structure of the drug.
Drug Product  means a finished dosage form, e.g., tablet, capsule, or solution, that contains the active drug ingredient, generally, but not necessarily, in association with inactive ingredients.
Generic Name  is the established, non proprietary or common name of the active drug in a drug product.
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. Each such drug product individually meets either the identical or its own respective compendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times and/or dissolution rates.
Pharmaceutical Equivalent  means drug products that contain identical amounts of the identical active drug ingredient, i.e., the salt or ester of the same therapeutic moiety, in identical dosage forms, but not necessarily containing the same inactive ingredients, and that meet the identical compendial or other applicable standard of identity, strength, quality, and purity, including potency and where applicable, content uniformity, disintegration times and/or dissolution rate.
Copyright 2001 David W.A. Bourne