Pharmaceutical equivalence
Term · Chemistry · MLC-T-CHM-008717
The relationship between drug products that contain the same amount of the same active substance in the same dosage form and route of administration and that meet the same or comparable quality standards for identity, strength, purity and quality. Excipients may differ. Pharmaceutical equivalence is required before bioequivalence is assessed, but it does not by itself establish that the products act identically in patients.
| Identifier | MLC-T-CHM-008717 |
|---|---|
| Field | Chemistry |
| Subject | Chemistry and Human Health |
| References | 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) |
| See also | Administration; Bioequivalence; Dosage form; Formulation; Generic |
Record as JSON
{
"id": "MLC-T-CHM-008717",
"term": "Pharmaceutical equivalence",
"field": "Chemistry",
"definition": "The relationship between drug products that contain the same amount of the same active substance in the same dosage form and route of administration and that meet the same or comparable quality standards for identity, strength, purity and quality. Excipients may differ. Pharmaceutical equivalence is required before bioequivalence is assessed, but it does not by itself establish that the products act identically in patients.",
"subject": "Chemistry and Human Health",
"see_also": [
"administration",
"bioequivalence",
"dosage form",
"formulation",
"generic"
],
"references": [
"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)"
],
"url": "https://mlchart.com/terminology/chemistry/pharmaceutical-equivalence/"
}
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