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An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence
Reference-scaled average bioequivalence (RSABE) has been recommended by Food and Drug Administration (FDA), and in its closely related form by European Medicines Agency (EMA), for the determination of bioequivalence (BE) of highly variable (HV) and narrow therapeutic index (NTI) drug products. FDA s...
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| Veröffentlicht in: | AAPS J |
|---|---|
| Hauptverfasser: | , |
| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
Springer US
2016
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| Schlagworte: | |
| Online Zugang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4779113/ https://ncbi.nlm.nih.gov/pubmed/26831249 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-016-9873-6 |
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