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Sequential Bioequivalence Approaches for Parallel Designs
Regulators in EU, USA and Canada allow the use of two-stage approaches for evaluation of bioequivalence. The purpose of this paper is to evaluate such designs for parallel groups using trial simulations. The methods developed by Diane Potvin and co-workers were adapted to parallel designs. Trials we...
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer US
2014
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| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4012040/ https://ncbi.nlm.nih.gov/pubmed/24526610 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-014-9571-1 |
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