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Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs
Various approaches for evaluating the bioequivalence (BE) of highly variable drugs (CV ≥ 30%) have been debated for many years. More recently, the FDA conducted research to evaluate one such approach: scaled average BE. A main objective of this study was to determine the impact of scaled average BE...
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| Autori principali: | , , , , , , |
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| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
Springer US
2008
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| Soggetti: | |
| Accesso online: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2761698/ https://ncbi.nlm.nih.gov/pubmed/18726698 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-008-9053-4 |
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