pharmaceutical equivalence
- Guideline or reference source
- CPMP/EWP/QWP/1401/98 Note for guidance on the investigation of bioavailability and bioequivalence
- Definition
- Medicinal products are pharmaceutically equivalent if they contain the same amount of the same active substance(s) in the same dosage forms that meet the same or comparable standards. Pharmaceutical equivalence does not necessarily imply bioequivalence as differences in the excipients and/or the manufacturing process can lead to faster or slower dissolution and/or absorption
- Related Term
- bioequivalence
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