You have already added 0 works in your ORCID record related to the merged Research product.
You have already added 0 works in your ORCID record related to the merged Research product.
Bioequivalence of Highly Variable Drugs
Bioequivalence of Highly Variable Drugs
Highly variable (HV) drugs are defined as those for which within-subject variability in bioequivalence (BE) measures is 30 % or greater. Studies designed to show whether a test highly variable drug product (either a generic or reformulated new drug) is bioequivalent to its corresponding reference highly variable drug product may need to enroll large numbers of subjects even when the products have no significant mean differences. To avoid unnecessary human testing, the US Food and Drug Administration (FDA) developed a reference-scaled average bioequivalence (RSABE) approach, whereby the BE acceptance limits are scaled to the variability of the reference product. For an acceptable RSABE study, an HV drug product must meet the scaled BE limit and a geometric mean ratio (GMR) constraint. The approach has been implemented successfully by the FDA, to date supporting approvals of both new generic drug products and reformulated modified-release (MR) new drug products.
- United States Food and Drug Administration United States
- Center for Drug Evaluation and Research United States
Microsoft Academic Graph classification: Generic drug Mathematics Bioequivalence Reliability engineering Geometric mean ratio Drug media_common.quotation_subject media_common Food and drug administration Reference product Limit (mathematics) Variable (computer science)
Microsoft Academic Graph classification: Generic drug Mathematics Bioequivalence Reliability engineering Geometric mean ratio Drug media_common.quotation_subject media_common Food and drug administration Reference product Limit (mathematics) Variable (computer science)
citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).3 popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.Average influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).Average impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.Average citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).3 popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.Average influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).Average impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.Average
Citations provided by BIP!Popularity provided by BIP!
- United States Food and Drug Administration United States
- Center for Drug Evaluation and Research United States
Highly variable (HV) drugs are defined as those for which within-subject variability in bioequivalence (BE) measures is 30 % or greater. Studies designed to show whether a test highly variable drug product (either a generic or reformulated new drug) is bioequivalent to its corresponding reference highly variable drug product may need to enroll large numbers of subjects even when the products have no significant mean differences. To avoid unnecessary human testing, the US Food and Drug Administration (FDA) developed a reference-scaled average bioequivalence (RSABE) approach, whereby the BE acceptance limits are scaled to the variability of the reference product. For an acceptable RSABE study, an HV drug product must meet the scaled BE limit and a geometric mean ratio (GMR) constraint. The approach has been implemented successfully by the FDA, to date supporting approvals of both new generic drug products and reformulated modified-release (MR) new drug products.