15223 IUPAC Gold Book - pharmaceutical equivalence 10.1351/goldbook.15223 15223 current 1 To be pharmaceutically equivalent, the generic and proprietary formulations must (1) contain the same amount of active ingredient; (2) contain the same active ingredient in the same dosage form; (3) be intended for the same route of administration; and (4) generally be labeled for the same conditions of use. It is not usually required that the generic and the reference drug contain the same excipients, or that the mechanism by which the active drug substance is released from the formulation be the same. But, the regulation authority approves the generic equivalent on the basis of certain in vitro and in vivo data. administration https://goldbook.iupac.org//terms/view/15143 bioequivalence https://goldbook.iupac.org//terms/view/15154 dosage form https://goldbook.iupac.org//terms/view/15175 formulations https://goldbook.iupac.org//terms/view/15188 nonproprietary https://goldbook.iupac.org//terms/view/15192 PAC, 2009, 81, 971. 'Glossary of terms related to pharmaceutics (IUPAC Recommendations 2009)' on page 993 (https://doi.org/10.1351/PAC-REC-04-10-14) https://goldbook.iupac.org/terms/view/15223/html https://goldbook.iupac.org/terms/view/15223/json https://goldbook.iupac.org/terms/view/15223/plain Citation: 'pharmaceutical equivalence' in IUPAC Compendium of Chemical Terminology, 5th ed. International Union of Pure and Applied Chemistry; 2025. Online version 5.0.0, 2025. 10.1351/goldbook.15223 The IUPAC Gold Book is licensed under Creative Commons Attribution-ShareAlike CC BY-SA 4.0 International (https://creativecommons.org/licenses/by-sa/4.0/) for individual terms. If you are interested in licensing the Gold Book for commercial use, please contact the IUPAC Executive Director at executivedirector@iupac.org . The International Union of Pure and Applied Chemistry (IUPAC) is continuously reviewing and, where needed, updating terms in the Compendium of Chemical Terminology (the IUPAC Gold Book). Users of these terms are encouraged to include the version of a term with its use and to check regularly for updates to term definitions that you are using. 2026-07-12T08:34:27+00:00