MLchartDataset catalogue

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.

Table 1. Record
IdentifierMLC-T-CHM-008717
FieldChemistry
SubjectChemistry and Human Health
ReferencesPAC, 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 alsoAdministration; 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/"
}

Record 9,254 of 13,676 in Chemistry terminology (MLC-0109). Request the full dataset.