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- NCIT_C71763 IAO_0000115 "The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. Where there is an intentional difference in rate (e.g., in certain controlled release dosage forms), certain pharmaceutical equivalents or alternatives may be considered bioequivalent if there is no significant difference in the extent to which the active ingredient or moiety from each product becomes available at the site of drug action. This applies only if the difference in the rate at which the active ingredient or moiety becomes available at the site of drug action is intentional and is reflected in the proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug (21CFR320.1)." @default.
- NCIT_C71763 NCIT_NHC0 "C71763" @default.
- NCIT_C71763 NCIT_P106 "Qualitative Concept" @default.
- NCIT_C71763 NCIT_P108 "Bioequivalence" @default.
- NCIT_C71763 NCIT_P207 "C0039789" @default.
- NCIT_C71763 NCIT_P322 "CDISC-GLOSS" @default.
- NCIT_C71763 NCIT_P325 "Scientific basis on which drugs with the same active ingredient(s) are compared. NOTE: To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions." @default.
- NCIT_C71763 NCIT_P366 "Bioequivalence" @default.
- NCIT_C71763 normalizedInformationContent "100" @default.
- NCIT_C71763 referenceCount "1" @default.
- NCIT_C71763 hasExactSynonym "Bioequivalence" @default.
- NCIT_C71763 hasExactSynonym "bioequivalence" @default.
- NCIT_C71763 inSubset NCIT_C61410 @default.
- NCIT_C71763 inSubset NCIT_C67497 @default.
- NCIT_C71763 type Class @default.
- NCIT_C71763 isDefinedBy ncit.owl @default.
- NCIT_C71763 label "Bioequivalence" @default.
- NCIT_C71763 subClassOf NCIT_C20189 @default.
- NCIT_C71763 subClassOf NCIT_C25447 @default.
- NCIT_C71763 subClassOf NCIT_C43242 @default.
- NCIT_C71763 subClassOf NCIT_C53450 @default.
- NCIT_C71763 subClassOf NCIT_C71763 @default.