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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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| 出版年: | AAPS J |
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| 主要な著者: | , |
| フォーマット: | Artigo |
| 言語: | Inglês |
| 出版事項: |
Springer US
2016
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| 主題: | |
| オンライン･アクセス: | 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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