의약품의 동등성/대체 조제

Therapeutic Equivalence/Generic Substituton

Many drugs are marketed by more than one pharmaceutical manufacturer. Because of the plethora of drug products containing the same amount of active drug, physicians, pharmacists, and others who prescribe, dispense, or purchase drugs must select generic products that produce an equivalent therapeutic effect to the brand product. Bioequivalent drug products are pharmaceutical equivalents that have similar bioavailability when given in the same molar dose. Therapeutic equivalents are drug products that contain the same therapeutically active drug that should give the same therapeutic effect and have equal potential for adverse effects under conditions set forth in the labels of these drug products. Therapeutic equivalent drug products must be (1) safe and effective, (2) pharmaceutical equivalents, (3) bioequivalent, (4) adequately labeled, and (5) manufactured in compliance with current good manufacturing practices. Generic subsitution is the process of dispensing a different brand or unbranded drug product in place of the prescribed drug product. The substituted drug product contains the same active ingredient or therapeutic moiety. This process requires the physician's permission.